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Pharmacokinetics and Safety Study of PT010 and PT003 in Healthy Chinese Adult Subjects

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ClinicalTrials.gov Identifier: NCT03075267
Recruitment Status : Completed
First Posted : March 9, 2017
Results First Posted : January 19, 2021
Last Update Posted : January 19, 2021
Sponsor:
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease
Interventions Drug: PT010 (BGF MDI) 320/14.4/9.6 µg
Drug: PT010 (BGF MDI) 160/14.4/9.6 µg
Drug: PT003 (GFF MDI) 14.4/9.6 µg
Enrollment 96
Recruitment Details This study was conducted at a single site in China.
Pre-assignment Details Subjects were randomized in a 1:1:1 ratio to 1 of 3 treatments: BGF MDI 320/14.4/9.6 μg, BGF MDI 160/14.4/9.6 μg, or GFF MDI 14.4/9.6 μg.
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Hide Arm/Group Description PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
Period Title: Overall Study
Started 32 32 32
Completed 31 32 32
Not Completed 1 0 0
Reason Not Completed
Protocol Violation             1             0             0
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg Total
Hide Arm/Group Description PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg Total of all reporting groups
Overall Number of Baseline Participants 32 32 32 96
Overall Number of Units Analyzed
Type of Units Analyzed: Demographics
32 32 32 96
Hide Baseline Analysis Population Description
Safety Population - all subjects who received at least 1 dose of any blinded study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 32 participants 32 participants 96 participants
25.1  (3.8) 26.9  (5.1) 24.7  (4.1) 25.6  (4.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 32 participants 32 participants 96 participants
Female
7
  21.9%
6
  18.8%
3
   9.4%
16
  16.7%
Male
25
  78.1%
26
  81.3%
29
  90.6%
80
  83.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Chinese subjects Number Analyzed 32 participants 32 participants 32 participants 96 participants
32 32 32 96
Smoking Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 32 participants 32 participants 96 participants
Non Smoker
28
  87.5%
29
  90.6%
30
  93.8%
87
  90.6%
Former Smoker
4
  12.5%
3
   9.4%
2
   6.3%
9
   9.4%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 32 participants 32 participants 32 participants 96 participants
59.99  (5.29) 60.00  (6.13) 62.75  (5.31) 60.91  (5.68)
BMI  
Median (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 32 participants 32 participants 32 participants 96 participants
21.5  (1.4) 21.6  (1.2) 21.9  (1.1) 21.7  (1.2)
1.Primary Outcome
Title Maximum Plasma Concentration (Cmax) - Budesonide
Hide Description Maximum plasma concentration (Cmax) of Budesonide Day 1
Time Frame Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
Overall Number of Participants Analyzed 32 32
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: pg/mL
459.308
(67.6%)
224.298
(98.1%)
2.Primary Outcome
Title Maximum Plasma Concentration (Cmax) - Budesonide
Hide Description Maximum plasma concentration (Cmax) of Budesonide Day 8
Time Frame Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
Overall Number of Participants Analyzed 31 32
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: pg/mL
626.435
(78.1%)
315.425
(80.2%)
3.Primary Outcome
Title Maximum Plasma Concentration (Cmax) - Glycopyrronium
Hide Description Maximum plasma concentration (Cmax) of Glycopyrronium Day 1
Time Frame Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
Overall Number of Participants Analyzed 32 31 31
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: pg/mL
4.884
(92.5%)
5.286
(120.8%)
5.674
(113.4%)
4.Primary Outcome
Title Maximum Plasma Concentration (Cmax) - Glycopyrronium
Hide Description Maximum plasma concentration (Cmax) of Glycopyrronium Day 8
Time Frame Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
Overall Number of Participants Analyzed 31 32 32
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: pg/mL
11.303
(96.9%)
11.754
(103.0%)
13.124
(82.3%)
5.Primary Outcome
Title Maximum Plasma Concentration (Cmax) - Formoterol
Hide Description Maximum plasma concentration (Cmax) of Formoterol Day 1
Time Frame Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
Overall Number of Participants Analyzed 32 32 32
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: pg/mL
9.651
(55.8%)
9.932
(71.9%)
10.618
(76.6%)
6.Primary Outcome
Title Maximum Plasma Concentration (Cmax) - Formoterol
Hide Description Maximum plasma concentration (Cmax) of Formoterol Day 8
Time Frame Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
Overall Number of Participants Analyzed 31 32 32
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: pg/mL
16.125
(59.1%)
16.945
(54.5%)
17.710
(57.6%)
7.Primary Outcome
Title Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Budesonide
Hide Description Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Budesonide Day 1
Time Frame Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
Overall Number of Participants Analyzed 32 32
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*pg/mL
1747.910
(43.5%)
811.812
(58.2%)
8.Primary Outcome
Title Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Budesonide
Hide Description Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Budesonide Day 8
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
Overall Number of Participants Analyzed 31 32
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*pg/mL
2509.888
(53.4%)
1249.615
(52.0%)
9.Primary Outcome
Title Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Glycopyrronium
Hide Description Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Glycopyrronium Day 1
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
Overall Number of Participants Analyzed 20 19 20
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*pg/mL
29.400
(23.5%)
27.197
(41.3%)
29.002
(42.6%)
10.Primary Outcome
Title Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Glycopyrronium
Hide Description Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Glycopyrronium Day 8
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
Overall Number of Participants Analyzed 29 28 31
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*pg/mL
69.487
(64.8%)
77.078
(47.5%)
72.636
(57.2%)
11.Primary Outcome
Title Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Formoterol
Hide Description Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Formoterol Day 1
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
Overall Number of Participants Analyzed 32 32 28
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*pg/mL
47.843
(35.0%)
46.492
(39.3%)
53.583
(38.0%)
12.Primary Outcome
Title Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Formoterol
Hide Description Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Formoterol Day 8
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
Overall Number of Participants Analyzed 31 32 32
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*pg/mL
81.936
(39.5%)
85.322
(34.0%)
83.499
(37.8%)
13.Primary Outcome
Title Time to Maximum Plasma Concentration (Tmax) - Budesonide
Hide Description Time to maximum plasma concentration (tmax) - Budesonide Day 1
Time Frame Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
Overall Number of Participants Analyzed 32 32
Median (Full Range)
Unit of Measure: h
0.333
(0.10 to 2.00)
0.333
(0.10 to 2.00)
14.Primary Outcome
Title Time to Maximum Plasma Concentration (Tmax) - Budesonide
Hide Description Time to maximum plasma concentration (tmax) - Budesonide Day 8
Time Frame Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
Overall Number of Participants Analyzed 31 32
Median (Full Range)
Unit of Measure: h
0.333
(0.10 to 4.00)
0.333
(0.03 to 4.00)
15.Primary Outcome
Title Time to Maximum Plasma Concentration (Tmax) - Glycopyrronium
Hide Description Time to maximum plasma concentration (tmax) - Glycopyrronium Day 1
Time Frame Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
Overall Number of Participants Analyzed 32 31 31
Median (Full Range)
Unit of Measure: h
0.100
(0.03 to 2.00)
0.100
(0.03 to 4.00)
0.100
(0.03 to 4.00)
16.Primary Outcome
Title Time to Maximum Plasma Concentration (Tmax) - Glycopyrronium
Hide Description Time to maximum plasma concentration (tmax) - Glycopyrronium Day 8
Time Frame Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
Overall Number of Participants Analyzed 31 32 32
Median (Full Range)
Unit of Measure: h
0.333
(0.03 to 4.00)
0.333
(0.03 to 4.00)
0.333
(0.03 to 2.00)
17.Primary Outcome
Title Time to Maximum Plasma Concentration (Tmax) - Formoterol
Hide Description Time to maximum plasma concentration (tmax) - Formoterol Day 1
Time Frame Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
Overall Number of Participants Analyzed 32 32 32
Median (Full Range)
Unit of Measure: h
0.833
(0.10 to 2.00)
0.100
(0.10 to 2.00)
0.100
(0.10 to 2.00)
18.Primary Outcome
Title Time to Maximum Plasma Concentration (Tmax) - Formoterol
Hide Description Time to maximum plasma concentration (tmax) - Formoterol Day 8
Time Frame Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
Overall Number of Participants Analyzed 31 32 32
Median (Full Range)
Unit of Measure: h
0.100
(0.10 to 2.00)
0.100
(0.10 to 4.00)
0.100
(0.10 to 4.00)
19.Primary Outcome
Title Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Budesonide
Hide Description Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-t) - Budesonide Day 1
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
Overall Number of Participants Analyzed 32 32
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*pg/mL
1884.912
(43.5%)
830.012
(61.1%)
20.Primary Outcome
Title Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Glycopyrronium
Hide Description Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-t) - Glycopyrronium Day 1
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
Overall Number of Participants Analyzed 31 30 28
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*pg/mL
17.616
(89.8%)
17.707
(111.2%)
20.287
(103.3%)
21.Primary Outcome
Title Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Formoterol
Hide Description Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-t) - Formoterol Day 1
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
Overall Number of Participants Analyzed 32 32 32
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*pg/mL
48.326
(41.4%)
47.408
(48.2%)
45.950
(78.1%)
22.Primary Outcome
Title Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Budesonide
Hide Description Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Budesonide Day 1
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
Overall Number of Participants Analyzed 32 32
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*pg/mL
1936.211
(42.0%)
876.673
(58.8%)
23.Primary Outcome
Title Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Glycopyrronium
Hide Description Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Glycopyrronium Day 1
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
Overall Number of Participants Analyzed 5 1 3
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*pg/mL
35.465
(19.6%)
33.014 [1] 
(NA%)
43.537
(18.3%)
[1]
value assessed on only one patient - no coefficient of variation
24.Primary Outcome
Title Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Formoterol
Hide Description Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Formoterol Day 1
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
Overall Number of Participants Analyzed 21 18 19
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*pg/mL
61.617
(37.5%)
73.123
(40.5%)
70.608
(46.0%)
25.Primary Outcome
Title Elimination Half-life (t½) - Budesonide
Hide Description Elimination half-life (t½) - Budesonide Day 1
Time Frame Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
Overall Number of Participants Analyzed 32 32
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h
4.572
(25.3%)
3.168
(31.9%)
26.Primary Outcome
Title Elimination Half-life (t½) - Glycopyrronium
Hide Description Elimination half-life (t½) - Glycopyrronium Day 1
Time Frame Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
Overall Number of Participants Analyzed 20 14 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h
5.676
(52.5%)
8.539
(161.3%)
6.194
(108.2%)
27.Primary Outcome
Title Elimination Half-life (t½) - Formoterol
Hide Description Elimination half-life (t½) - Formoterol Day 1
Time Frame Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
Overall Number of Participants Analyzed 31 32 28
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h
5.098
(22.7%)
5.657
(38.1%)
5.628
(34.2%)
28.Primary Outcome
Title Apparent Total Body Clearance (CL/F) - Budesonide
Hide Description Apparent total body clearance (CL/F) - Budesonide Day 1
Time Frame Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
Overall Number of Participants Analyzed 32 32
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L/h
165.271
(42.0%)
182.508
(58.8%)
29.Primary Outcome
Title Apparent Total Body Clearance (CL/F) - Glycopyrronium
Hide Description Apparent total body clearance (CL/F) - Glycopyrronium Day 1
Time Frame Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
Overall Number of Participants Analyzed 5 1 3
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L/h
406.038
(19.6%)
436.184 [1] 
(NA%)
330.757
(18.3%)
[1]
value assessed on only one patient - no coefficient of variation
30.Primary Outcome
Title Apparent Total Body Clearance (CL/F) - Formoterol
Hide Description Apparent total body clearance (CL/F) - Formoterol Day 1
Time Frame Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
Overall Number of Participants Analyzed 21 18 19
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L/h
155.801
(37.5%)
131.286
(40.5%)
135.962
(46.0%)
31.Primary Outcome
Title Apparent Volume of Distribution (Vd/F) - Budesonide
Hide Description Apparent volume of distribution (Vd/F) - Budesonide - Day 1
Time Frame Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
Overall Number of Participants Analyzed 32 32
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L
1090.237
(43.0%)
834.269
(56.2%)
32.Primary Outcome
Title Apparent Volume of Distribution (Vd/F) - Glycopyrronium
Hide Description Apparent volume of distribution (Vd/F) - Glycopyrronium - Day 1
Time Frame Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
Overall Number of Participants Analyzed 5 1 3
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L
2172.038
(17.6%)
2123.999 [1] 
(NA%)
1864.314
(49.8%)
[1]
value assessed on only one patient - no coefficient of variation
33.Primary Outcome
Title Apparent Volume of Distribution (Vd/F) - Formoterol
Hide Description Apparent volume of distribution (Vd/F) - Formoterol - Day 1
Time Frame Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
Overall Number of Participants Analyzed 21 18 19
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L
1125.215
(26.0%)
1000.172
(29.2%)
1035.257
(30.9%)
34.Primary Outcome
Title Terminal Elimination Rate Constant (λz) - Budesonide
Hide Description Terminal elimination rate constant (λz) - Budesonide - Day 1
Time Frame Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
Overall Number of Participants Analyzed 32 32
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: 1/h
0.152
(25.3%)
0.219
(31.9%)
35.Primary Outcome
Title Terminal Elimination Rate Constant (λz) - Glycopyrronium
Hide Description Terminal elimination rate constant (λz) - Glycopyrronium - Day 1
Time Frame Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
Overall Number of Participants Analyzed 20 14 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: 1/h
0.122
(52.5%)
0.081
(161.3%)
0.112
(108.2%)
36.Primary Outcome
Title Terminal Elimination Rate Constant (λz) - Formoterol
Hide Description Terminal elimination rate constant (λz) - Formoterol - Day 1
Time Frame Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
Overall Number of Participants Analyzed 31 32 28
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: 1/h
0.136
(22.7%)
0.123
(38.1%)
0.123
(34.2%)
37.Primary Outcome
Title Accumulation Ratio for Cmax (RAC [Cmax]) - Budesonide
Hide Description Accumulation ratio for Cmax (RAC [Cmax]) - Budesonide
Time Frame Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose and Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
Overall Number of Participants Analyzed 31 32
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
1.400
(71.4%)
1.406
(62.6%)
38.Primary Outcome
Title Accumulation Ratio for Cmax (RAC [Cmax]) - Glycopyrronium
Hide Description Accumulation ratio for Cmax (RAC [Cmax]) - Glycopyrronium
Time Frame Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose and Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
Overall Number of Participants Analyzed 31 31 31
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
2.383
(86.4%)
2.319
(90.3%)
2.412
(89.7%)
39.Primary Outcome
Title Accumulation Ratio for Cmax (RAC [Cmax]) - Formoterol
Hide Description Accumulation ratio for Cmax (RAC [Cmax]) - Formoterol
Time Frame Day 1 and Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
Overall Number of Participants Analyzed 31 32 32
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
1.678
(50.1%)
1.706
(42.1%)
1.668
(62.2%)
40.Primary Outcome
Title Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Budesonide
Hide Description Accumulation ratio for AUC 0-12 (RAC [AUC 0-12]) - Budesonide
Time Frame Day 1 and Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
Overall Number of Participants Analyzed 31 32
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
1.455
(45.9%)
1.539
(37.1%)
41.Primary Outcome
Title Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Glycopyrronium
Hide Description Accumulation ratio for AUC 0-12 (RAC [AUC 0-12]) - Glycopyrronium
Time Frame Day 1 and Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
Overall Number of Participants Analyzed 18 18 19
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
3.324
(47.5%)
3.030
(43.0%)
3.189
(31.5%)
42.Primary Outcome
Title Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Formoterol
Hide Description Accumulation ratio for AUC 0-12 (RAC [AUC 0-12]) - Formoterol
Time Frame Day 1 and Day 8
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Hide Analysis Population Description
PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
Overall Number of Participants Analyzed 31 32 28
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
1.718
(28.7%)
1.835
(26.2%)
1.620
(27.5%)
43.Secondary Outcome
Title Physical Exam Findings
Hide Description Number of subjects with clinically significant changes in post baseline physical exam findings
Time Frame Visit 4, Day 8
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Safety Population
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
Overall Number of Participants Analyzed 32 32 32
Measure Type: Count of Participants
Unit of Measure: Participants
Significant Findings
0
   0.0%
0
   0.0%
0
   0.0%
44.Secondary Outcome
Title Laboratory Tests
Hide Description Number of subjects with clinically significant changes in post baseline laboratory tests
Time Frame Visit 4, Day 8
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Safety Population
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
Overall Number of Participants Analyzed 32 32 32
Measure Type: Count of Participants
Unit of Measure: Participants
Potassium
0
   0.0%
1
   3.1%
0
   0.0%
45.Secondary Outcome
Title Electrocardiogram
Hide Description Number of subjects with clinically significant changes in post baseline electrocardiogram
Time Frame Visit 4, Day 8
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Safety Population
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
Overall Number of Participants Analyzed 32 32 32
Measure Type: Count of Participants
Unit of Measure: Participants
Significant electrocardiogram changes
0
   0.0%
0
   0.0%
0
   0.0%
46.Secondary Outcome
Title Serious Adverse Events/Adverse Events
Hide Description Number of subjects with clinically significant changes in post baseline serious TEAEs (treatment-emergent adverse events) or TEAEs leading to withdrawal
Time Frame Visit 4, Day 8
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Safety Population
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
Overall Number of Participants Analyzed 32 32 32
Measure Type: Count of Participants
Unit of Measure: Participants
Serious TEAEs/TEAEs leading to withdrawal
0
   0.0%
0
   0.0%
0
   0.0%
47.Secondary Outcome
Title Vital Signs
Hide Description Number of subjects with clinically significant changes in post baseline vital signs
Time Frame Visit 4, Day 8
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Safety Population
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Hide Arm/Group Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
Overall Number of Participants Analyzed 32 32 32
Measure Type: Count of Participants
Unit of Measure: Participants
Bradycardia events
2
   6.3%
0
   0.0%
0
   0.0%
Time Frame Adverse Events were collected from the first administration of study drug through the Final Telephone Follow-up.
Adverse Event Reporting Description The Safety Population was defined as all subjects who receive at least one dose of any blinded study drug. Serious Adverse Events were collected from the first administration of study drug up to 14 days following the last dose of study drug administration.
 
Arm/Group Title PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Hide Arm/Group Description PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
All-Cause Mortality
PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)      0/32 (0.00%)      0/32 (0.00%)    
Hide Serious Adverse Events
PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/32 (0.00%)      0/32 (0.00%)      0/32 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PT010 (BGF MDI) 320/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/32 (43.75%)      11/32 (34.38%)      14/32 (43.75%)    
General disorders       
Sensation of foreign body  1  1/32 (3.13%)  1 1/32 (3.13%)  1 3/32 (9.38%)  3
Investigations       
Blood glucose increased  1  4/32 (12.50%)  4 3/32 (9.38%)  3 4/32 (12.50%)  4
Blood potassium increased  1  2/32 (6.25%)  2 1/32 (3.13%)  2 5/32 (15.63%)  5
Blood potassium decreased  1  2/32 (6.25%)  3 4/32 (12.50%)  4 1/32 (3.13%)  1
Bilirubin conjugated increased  1  0/32 (0.00%)  0 1/32 (3.13%)  1 2/32 (6.25%)  2
Blood bilirubin increased  1  0/32 (0.00%)  0 1/32 (3.13%)  1 2/32 (6.25%)  2
Blood uric acid increased  1  2/32 (6.25%)  2 1/32 (3.13%)  1 0/32 (0.00%)  0
Alanine aminotransferase increased  1  0/32 (0.00%)  0 0/32 (0.00%)  0 2/32 (6.25%)  2
Blood glucose decreased  1  2/32 (6.25%)  2 0/32 (0.00%)  0 0/32 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Dry throat  1  3/32 (9.38%)  3 2/32 (6.25%)  2 4/32 (12.50%)  4
Oropharyngeal pain  1  2/32 (6.25%)  2 1/32 (3.13%)  1 2/32 (6.25%)  3
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The study site will have the opportunity to publish the results of the study, provided that the sponsor has had the opportunity to review and comment on the study site's proposed publication prior to its being submitted for publication with the prior advice of legal (intellectual property counsel) and with proper regard to the protection of subjects' identities.
Results Point of Contact
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Name/Title: Pearl Therapeutics, Inc.
Organization: Pearl Therapeutics, Inc.
Phone: 1-877-240-9479
EMail: information.center@astrazeneca.com
Layout table for additonal information
Responsible Party: Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03075267    
Other Study ID Numbers: PT010010
First Submitted: March 6, 2017
First Posted: March 9, 2017
Results First Submitted: June 11, 2020
Results First Posted: January 19, 2021
Last Update Posted: January 19, 2021