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Study to Assess Efficacy and Safety of PT009 Compared to PT005, PT008, and Symbicort® Turbuhaler® on Lung Function Over 24-Weeks in Subjects With Moderate to Very Severe COPD (telos)

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ClinicalTrials.gov Identifier: NCT02766608
Recruitment Status : Completed
First Posted : May 10, 2016
Results First Posted : September 24, 2019
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disorder
Interventions Drug: BFF MDI 320/9.6 μg
Drug: BFF MDI 160/9.6 μg
Drug: FF MDI 9.6 μg
Drug: BD MDI 320 μg
Drug: Symbicort® TBH 400/12 μg BID
Enrollment 2389
Recruitment Details This study randomized subjects at 244 study centers in 7 countries, from June 2016 and November 2017. The study period was scheduled to take up to approximately 30 weeks for each individual subject from the time of screening through the follow-up period.
Pre-assignment Details Subjects were randomized in a 3:3:3:1:1 ratio to BFF 320/9.6, BFF 160/9.6, FF 9.6, BD 320, and Symbicort.
Arm/Group Title BFF MDI 320/9.6 μg BFF MDI 160/9.6 μg FF MDI 9.6 μg BD MDI 320 μg Symbicort TBH 400/12 μg
Hide Arm/Group Description Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg Formoterol Fumarate Metered Dose Inhalation 9.6 μg Budesonide Metered Dose Inhalation 320 μg Symbicort Turbuhaler 400/12 μg
Period Title: Overall Study
Started [1] 655 637 644 206 219
Completed [2] 576 567 554 169 190
Not Completed 79 70 90 37 29
Reason Not Completed
Adverse Event             27             22             17             13             12
Withdrawal by Subject             21             20             24             13             10
Lack of Efficacy             16             15             32             8             2
Lost to Follow-up             6             3             5             2             2
Physician Decision             3             2             3             1             2
Protocol disc criteria             3             3             4             0             0
Protocol Violation             0             4             4             0             1
Administrative Reasons             3             1             1             0             0
[1]
mITT Population
[2]
Completed Treatment
Arm/Group Title BFF MDI 320/9.6 μg BFF MDI 160/9.6 μg FF MDI 9.6 μg BD MDI 320 μg Symbicort TBH 400/12 μg Total
Hide Arm/Group Description Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg Formoterol Fumarate Metered Dose Inhalation 9.6 μg Budesonide Metered Dose Inhalation 320 μg Symbicort Turbuhaler 400/12 μg Total of all reporting groups
Overall Number of Baseline Participants 664 649 648 209 219 2389
Hide Baseline Analysis Population Description
The Modified Intent-To-Treat (mITT) Population is a subset of the ITT Population, and is defined as all subjects with post-randomization data obtained prior to discontinuation from treatment. The Intent-To-Treat (ITT) Population is defined as all subjects who were randomized to treatment and received any amount of the study treatment.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 655 participants 637 participants 644 participants 206 participants 219 participants 2361 participants
64.2  (7.7) 64.3  (7.6) 64.1  (8.0) 64.2  (7.4) 65.3  (7.0) 64.3  (7.7)
[1]
Measure Analysis Population Description: mITT
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Values listed are mITT population Number Analyzed 655 participants 637 participants 644 participants 206 participants 219 participants 2361 participants
Female
253
  38.6%
260
  40.8%
261
  40.5%
81
  39.3%
78
  35.6%
933
  39.5%
Male
402
  61.4%
377
  59.2%
383
  59.5%
125
  60.7%
141
  64.4%
1428
  60.5%
[1]
Measure Analysis Population Description: mITT
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Values listed are mITT population Number Analyzed 655 participants 637 participants 644 participants 206 participants 219 participants 2361 participants
Hispanic or Latino
16
   2.4%
18
   2.8%
21
   3.3%
8
   3.9%
6
   2.7%
69
   2.9%
Not Hispanic or Latino
637
  97.3%
616
  96.7%
623
  96.7%
198
  96.1%
212
  96.8%
2286
  96.8%
Unknown or Not Reported
2
   0.3%
3
   0.5%
0
   0.0%
0
   0.0%
1
   0.5%
6
   0.3%
[1]
Measure Analysis Population Description: mITT
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Values listed are mITT population Number Analyzed 655 participants 637 participants 644 participants 206 participants 219 participants 2361 participants
American Indian or Alaska Native
2
   0.3%
2
   0.3%
2
   0.3%
0
   0.0%
0
   0.0%
6
   0.3%
Asian
1
   0.2%
1
   0.2%
0
   0.0%
0
   0.0%
1
   0.5%
3
   0.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
19
   2.9%
15
   2.4%
20
   3.1%
9
   4.4%
8
   3.7%
71
   3.0%
White
633
  96.6%
619
  97.2%
622
  96.6%
197
  95.6%
210
  95.9%
2281
  96.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description: mITT
1.Primary Outcome
Title Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (BFF MDI Versus FF MDI)
Hide Description Change from baseline in morning pre-dose trough FEV1 (Forced expiratory volume in 1 second) at Week 24 (BFF MDI versus FF MDI)
Time Frame at Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title BFF MDI 320/9.6 μg BFF MDI 160/9.6 μg FF MDI 9.6 μg
Hide Arm/Group Description:
Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg
Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg
Formoterol Fumarate Metered Dose Inhalation 9.6 μg
Overall Number of Participants Analyzed 571 564 550
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liter
0.036
(0.019 to 0.053)
0.017
(0.000 to 0.034)
-0.003
(-0.020 to 0.015)
2.Primary Outcome
Title Change From Baseline in FEV1 AUC0-4 (BFF MDI vs BD MDI)
Hide Description Changes from baseline in FEV1 AUC0-4 were normalized by taking the area under the curve value and dividing by the length of time under consideration (usually 4 hours). This normalization represents a weighted average of the change from baseline in FEV1 over the 4-hour period.
Time Frame at Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title BFF MDI 320/9.6 μg BFF MDI 160/9.6 μg FF MDI 9.6 ug BD MDI 320 ug Symbicort TBH 400/12 ug
Hide Arm/Group Description:
Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg
Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg
Formoterol Fumarate Metered Dose Inhalation 9.6 μg
Budesonide Metered Dose Inhalation 320 μg
Symbicort Turbuhaler 400/12 ug
Overall Number of Participants Analyzed 571 565 549 168 189
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liter
0.194
(0.177 to 0.212)
0.179
(0.161 to 0.197)
0.161
(0.143 to 0.179)
0.022
(-0.011 to 0.054)
0.187
(0.157 to 0.218)
3.Secondary Outcome
Title Time to First Moderate or Severe COPD Exacerbation (BFF MDI vs FF MDI).
Hide Description Time to first moderate or severe COPD (Chronic Obstructive Pulmonary Disease) exacerbation (BFF MDI vs FF MDI).
Time Frame over 24 Weeks (timepoints of 4, 12 & 20 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title BFF MDI 320/9.6 μg BFF MDI 160/9.6 μg FF MDI 9.6 μg BD MDI 320 μg Symbicort TBH 400/12 ug
Hide Arm/Group Description:
Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg
Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg
Formoterol Fumarate Metered Dose Inhalation 9.6 μg
Budesonide Metered Dose Inhalation 320 μg
Symbicort Turbuhaler 400/12 ug
Overall Number of Participants Analyzed 655 637 644 206 219
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Percentage of Subjects to Exacerbate at 4 Weeks
3.2
(2.1 to 4.9)
3.3
(2.2 to 5.1)
5.5
(4.0 to 7.6)
7.0
(4.2 to 11.5)
1.8
(0.7 to 4.8)
Percentage of Subjects to Exacerbate at 12 Weeks
9.8
(7.7 to 12.4)
9.9
(7.8 to 12.5)
15.0
(12.4 to 18.1)
14.9
(10.6 to 20.7)
8.6
(5.5 to 13.3)
Percentage of Subjects to Exacerbate at 20 Weeks
14.4
(11.9 to 17.4)
18.5
(15.6 to 21.8)
20.5
(17.5 to 23.9)
17.7
(13.0 to 23.9)
13.1
(9.2 to 18.6)
4.Secondary Outcome
Title Percentage of Subjects Achieving an MCID (Minimal Clinically Important Difference) of 4 Units or More in SGRQ at Week 24
Hide Description The SGRQ (St. George's Respiratory Questionnaire) is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of BFF MDI, FF MDI, BD MDI, & Symbicort TBH on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life.
Time Frame at Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title BFF MDI 320/9.6 μg BFF MDI 160/9.6 μg FF MDI 9.6 μg BD MDI 320 μg Symbicort TBH 400/12 μg
Hide Arm/Group Description:
Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg
Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg
Formoterol Fumarate Metered Dose Inhalation 9.6 μg
Budesonide Metered Dose Inhalation 320 μg
Symbicort Turbuhaler 400/12 μg
Overall Number of Participants Analyzed 649 635 640 204 217
Measure Type: Number
Unit of Measure: Percentage of Subjects
48.12 47.22 41.59 43.62 53.78
5.Secondary Outcome
Title Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (BFF MDI vs BD MDI)
Hide Description Change from baseline in morning pre-dose trough FEV1(Forced Expiratory Volume in 1 second) at Week 24 (BFF MDI vs BD MDI)
Time Frame at Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title BFF MDI 320/9.6 μg BFF MDI 160/9.6 μg FF MDI 9.6 μg BD MDI 320 μg Symbicort TBH 400/12 μg
Hide Arm/Group Description:
Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg
Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg
Formoterol Fumarate Metered Dose Inhalation 9.6 μg
Budesonide Metered Dose Inhalation 320 μg
Symbicort Turbuhaler 400/12 μg
Overall Number of Participants Analyzed 571 564 550 168 189
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liter
0.036
(0.019 to 0.053)
0.017
(0.000 to 0.034)
-0.003
(-0.020 to 0.015)
-0.028
(-0.060 to 0.003)
0.039
(0.009 to 0.069)
6.Secondary Outcome
Title Peak Change From Baseline in FEV1 at Week 24 (BFF MDI vs BD MDI)
Hide Description Peak change from baseline in FEV1 (Forced Expiratory Volume in 1 second) at Week 24 (BFF MDI vs BD MDI)
Time Frame at Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title BFF MDI 320/9.6 μg BFF MDI 160/9.6 μg FF MDI 9.6 μg BD MDI 320 μg Symbicort TBH 400/12 μg
Hide Arm/Group Description:
Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg
Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg
Formoterol Fumarate Metered Dose Inhalation 9.6 μg
Budesonide Metered Dose Inhalation 320 μg
Symbicort Turbuhaler 400/12 μg
Overall Number of Participants Analyzed 571 565 549 168 189
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liter
0.272
(0.254 to 0.291)
0.258
(0.239 to 0.276)
0.243
(0.224 to 0.261)
0.116
(0.082 to 0.150)
0.267
(0.253 to 0.299)
7.Secondary Outcome
Title Change From Baseline in Average Daily Rescue Ventolin HFA Use Over 24 Weeks (BFF MDI vs BD MDI)
Hide Description Change from baseline in average daily rescue Ventolin HFA use over 24 weeks (BFF MDI vs BD MDI)
Time Frame over 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title BFF MDI 320/9.6 μg BFF MDI 160/9.6 μg FF MDI 9.6 μg BD MDI 320 μg Symbicort TBH 400/12 μg
Hide Arm/Group Description:
Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg
Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg
Formoterol Fumarate Metered Dose Inhalation 9.6 μg
Budesonide Metered Dose Inhalation 320 μg
Symbicort Turbuhaler 400/12 μg
Overall Number of Participants Analyzed 654 636 641 206 218
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Puffs per day
-1.3
(-1.5 to -1.1)
-1.3
(-1.4 to -1.1)
-1.1
(-1.2 to -0.9)
-0.6
(-0.9 to -0.3)
-1.2
(-1.5 to -0.9)
8.Secondary Outcome
Title FEV1 on Day 1, 5 Minutes, Time to Onset of Action Determination
Hide Description Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.
Time Frame Day 1 - 5 Minutes
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title BFF MDI 320/9.6 μg BFF MDI 160/9.6 μg FF MDI 9.6 μg BD MDI 320 μg Symbicort TBH 400/12 μg
Hide Arm/Group Description:
Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg
Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg
Formoterol Fumarate Metered Dose Inhalation 9.6 μg
Budesonide Metered Dose Inhalation 320 μg
Symbicort Turbuhaler 400/12 μg
Overall Number of Participants Analyzed 535 536 534 171 173
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liter
0.157
(0.148 to 0.166)
0.151
(0.142 to 0.161)
0.160
(0.150 to 0.169)
0.025
(0.009 to 0.041)
0.131
(0.115 to 0.148)
9.Secondary Outcome
Title FEV1 on Day 1, 15 Minutes, Time to Onset of Action Determination
Hide Description Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.
Time Frame Day 1 - 15 Minutes
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title BFF MDI 320/9.6 μg BFF MDI 160/9.6 μg FF MDI 9.6 μg BD MDI 320 μg Symbicort TBH 400/12 μg
Hide Arm/Group Description:
Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg
Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg
Formoterol Fumarate Metered Dose Inhalation 9.6 μg
Budesonide Metered Dose Inhalation 320 μg
Symbicort Turbuhaler 400/12 μg
Overall Number of Participants Analyzed 624 615 612 203 211
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liter
0.190
(0.180 to 0.200)
0.186
(0.176 to 0.196)
0.201
(0.191 to 0.211)
0.040
(0.022 to 0.058)
0.167
(0.149 to 0.184)
10.Secondary Outcome
Title FEV1 on Day 1, 30 Minutes, Time to Onset of Action Determination
Hide Description Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.
Time Frame Day 1 - 30 Minutes
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title BFF MDI 320/9.6 μg BFF MDI 160/9.6 μg FF MDI 9.6 μg BD MDI 320 μg Symbicort TBH 400/12 μg
Hide Arm/Group Description:
Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg
Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg
Formoterol Fumarate Metered Dose Inhalation 9.6 μg
Budesonide Metered Dose Inhalation 320 μg
Symbicort Turbuhaler 400/12 μg
Overall Number of Participants Analyzed 648 627 638 203 214
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liter
0.207
(0.196 to 0.217)
0.207
(0.196 to 0.218)
0.215
(0.205 to 0.226)
0.047
(0.028 to 0.066)
0.190
(0.172 to 0.209)
11.Secondary Outcome
Title FEV1 on Day 1, 1 Hour, Time to Onset of Action Determination
Hide Description Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.
Time Frame Day 1 - 1 Hour
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title BFF MDI 320/9.6 μg BFF MDI 160/9.6 μg FF MDI 9.6 μg BD MDI 320 μg Symbicort TBH 400/12 μg
Hide Arm/Group Description:
Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg
Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg
Formoterol Fumarate Metered Dose Inhalation 9.6 μg
Budesonide Metered Dose Inhalation 320 μg
Symbicort Turbuhaler 400/12 μg
Overall Number of Participants Analyzed 649 628 640 204 215
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liter
0.225
(0.213 to 0.236)
0.221
(0.210 to 0.233)
0.236
(0.225 to 0.248)
0.053
(0.033 to 0.073)
0.211
(0.191 to 0.231)
12.Secondary Outcome
Title FEV1 on Day 1, 2 Hours, Time to Onset of Action Determination
Hide Description Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.
Time Frame Day 1 - 2 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title BFF MDI 320/9.6 μg BFF MDI 160/9.6 μg FF MDI 9.6 μg BD MDI 320 μg Symbicort TBH 400/12 μg
Hide Arm/Group Description:
Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg
Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg
Formoterol Fumarate Metered Dose Inhalation 9.6 μg
Budesonide Metered Dose Inhalation 320 μg
Symbicort Turbuhaler 400/12 μg
Overall Number of Participants Analyzed 649 629 636 205 217
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liter
0.253
(0.241 to 0.265)
0.234
(0.222 to 0.247)
0.244
(0.231 to 0.256)
0.063
(0.042 to 0.085)
0.221
(0.200 to 0.243)
13.Secondary Outcome
Title FEV1 on Day 1, 4 Hours, Time to Onset of Action Determination
Hide Description Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.
Time Frame Day 1 - 4 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title BFF MDI 320/9.6 μg BFF MDI 160/9.6 μg FF MDI 9.6 μg BD MDI 320 μg Symbicort TBH 400/12 μg
Hide Arm/Group Description:
Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg
Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg
Formoterol Fumarate Metered Dose Inhalation 9.6 μg
Budesonide Metered Dose Inhalation 320 μg
Symbicort Turbuhaler 400/12 μg
Overall Number of Participants Analyzed 651 630 634 201 217
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liter
0.230
(0.216 to 0.243)
0.215
(0.202 to 0.229)
0.212
(0.199 to 0.226)
0.073
(0.049 to 0.097)
0.209
(0.186 to 0.232)
14.Other Pre-specified Outcome
Title Substudy: 12-hour PFT Endpoint FEV1 AUC0-12
Hide Description Substudy: 12-hour PFT (Pulmonary Function Test) endpoint FEV1 (Forced Expiratory Volume) AUC0-12 (Area under the Curve 0-12). Changes from baseline in FEV1 AUC0-12 were normalized by taking the area under the curve value and dividing by the length of time under consideration. This normalization represents a weighted average of the change from baseline in FEV1 over the 12-hour period.
Time Frame at Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title BFF MDI 320/9.6 μg BFF MDI 160/9.6 μg FF MDI 9.6 μg BD MDI 320 μg
Hide Arm/Group Description:
Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg
Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg
Formoterol Fumarate Metered Dose Inhalation 9.6 μg
Budesonide Metered Dose Inhalation 320 μg
Overall Number of Participants Analyzed 160 167 189 47
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liter
0.135
(0.107 to 0.163)
0.124
(0.097 to 0.152)
0.117
(0.089 to 0.145)
0.024
(-0.028 to 0.075)
Time Frame Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug
Adverse Event Reporting Description Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
 
Arm/Group Title BFF MDI 320/9.6 μg BFF MDI 160/9.6 μg FF MDI 9.6 μg BD MDI 320 μg Symbicort TBH 400/12 μg
Hide Arm/Group Description Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg Formoterol Fumarate Metered Dose Inhalation 9.6 μg Budesonide Metered Dose Inhalation 320 μg Symbicort Turbuhaler 400/12 μg
All-Cause Mortality
BFF MDI 320/9.6 μg BFF MDI 160/9.6 μg FF MDI 9.6 μg BD MDI 320 μg Symbicort TBH 400/12 μg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/655 (0.46%)      2/637 (0.31%)      2/644 (0.31%)      0/206 (0.00%)      2/219 (0.91%)    
Hide Serious Adverse Events
BFF MDI 320/9.6 μg BFF MDI 160/9.6 μg FF MDI 9.6 μg BD MDI 320 μg Symbicort TBH 400/12 μg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   42/655 (6.41%)      45/637 (7.06%)      72/644 (11.18%)      15/206 (7.28%)      20/219 (9.13%)    
Cardiac disorders           
Atrial fibrillation † 1  1/655 (0.15%)  1 5/637 (0.78%)  5 2/644 (0.31%)  2 1/206 (0.49%)  1 0/219 (0.00%)  0
Cardiac failure congestive † 1  1/655 (0.15%)  1 1/637 (0.16%)  1 1/644 (0.16%)  2 2/206 (0.97%)  2 1/219 (0.46%)  1
Acute myocardial infarction † 1  0/655 (0.00%)  0 2/637 (0.31%)  2 2/644 (0.31%)  2 0/206 (0.00%)  0 0/219 (0.00%)  0
Angina pectoris † 1  1/655 (0.15%)  1 2/637 (0.31%)  2 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Angina unstable † 1  0/655 (0.00%)  0 2/637 (0.31%)  2 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Atrial flutter † 1  1/655 (0.15%)  1 0/637 (0.00%)  0 1/644 (0.16%)  1 1/206 (0.49%)  1 0/219 (0.00%)  0
Cardiac failure † 1  2/655 (0.31%)  2 0/637 (0.00%)  0 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Cardiac failure chronic † 1  0/655 (0.00%)  0 2/637 (0.31%)  2 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Myocardial ischaemia † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 1/644 (0.16%)  2 1/206 (0.49%)  1 0/219 (0.00%)  0
Atrioventricular block complete † 1  0/655 (0.00%)  0 1/637 (0.16%)  1 0/644 (0.00%)  0 1/206 (0.49%)  1 0/219 (0.00%)  0
Cardiac arrest † 1  1/655 (0.15%)  1 1/637 (0.16%)  1 0/644 (0.00%)  0 0/206 (0.00%)  0 0/219 (0.00%)  0
Coronary artery disease † 1  0/655 (0.00%)  0 1/637 (0.16%)  1 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Arteriosclerosis coronary artery † 1  0/655 (0.00%)  0 1/637 (0.16%)  1 0/644 (0.00%)  0 0/206 (0.00%)  0 0/219 (0.00%)  0
Congestive cardiomyopathy † 1  0/655 (0.00%)  0 1/637 (0.16%)  1 0/644 (0.00%)  0 0/206 (0.00%)  0 0/219 (0.00%)  0
Coronary artery stenosis † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 0/644 (0.00%)  0 1/206 (0.49%)  1 0/219 (0.00%)  0
Myocardial infarction † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 0/644 (0.00%)  0 1/206 (0.49%)  1 0/219 (0.00%)  0
Eye disorders           
Cataract † 1  0/655 (0.00%)  0 1/637 (0.16%)  1 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Gastrointestinal disorders           
Small intestinal obstruction † 1  0/655 (0.00%)  0 1/637 (0.16%)  1 2/644 (0.31%)  2 0/206 (0.00%)  0 0/219 (0.00%)  0
Pancreatitis acute † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 0/644 (0.00%)  0 0/206 (0.00%)  0 2/219 (0.91%)  2
Abdominal pain † 1  1/655 (0.15%)  1 0/637 (0.00%)  0 0/644 (0.00%)  0 0/206 (0.00%)  0 0/219 (0.00%)  0
Colitis ischaemic † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Diverticulum intestinal † 1  0/655 (0.00%)  0 1/637 (0.16%)  1 0/644 (0.00%)  0 0/206 (0.00%)  0 0/219 (0.00%)  0
Gastrointestinal ulcer † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Hiatus hernia † 1  1/655 (0.15%)  1 0/637 (0.00%)  0 0/644 (0.00%)  0 0/206 (0.00%)  0 0/219 (0.00%)  0
Inflammatory bowel disease † 1  1/655 (0.15%)  1 0/637 (0.00%)  0 0/644 (0.00%)  0 0/206 (0.00%)  0 0/219 (0.00%)  0
Inguinal hernia † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 0/644 (0.00%)  0 1/206 (0.49%)  1 0/219 (0.00%)  0
Pancreatitis † 1  0/655 (0.00%)  0 1/637 (0.16%)  1 0/644 (0.00%)  0 0/206 (0.00%)  0 0/219 (0.00%)  0
Strangulated umbilical hernia † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 0/644 (0.00%)  0 1/206 (0.49%)  1 0/219 (0.00%)  0
Upper gastrointestinal haemorrhage † 1  0/655 (0.00%)  0 1/637 (0.16%)  1 0/644 (0.00%)  0 0/206 (0.00%)  0 0/219 (0.00%)  0
General disorders           
Chest discomfort † 1  1/655 (0.15%)  1 0/637 (0.00%)  0 0/644 (0.00%)  0 0/206 (0.00%)  0 0/219 (0.00%)  0
Chest pain † 1  1/655 (0.15%)  1 0/637 (0.00%)  0 0/644 (0.00%)  0 0/206 (0.00%)  0 0/219 (0.00%)  0
Death † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 0/644 (0.00%)  0 0/206 (0.00%)  0 1/219 (0.46%)  1
Incarcerated hernia † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Sudden cardiac death † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Hepatobiliary disorders           
Cholecystitis † 1  1/655 (0.15%)  1 0/637 (0.00%)  0 1/644 (0.16%)  1 1/206 (0.49%)  1 0/219 (0.00%)  0
Bile duct stone † 1  1/655 (0.15%)  1 0/637 (0.00%)  0 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Cholelithiasis † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 1/644 (0.16%)  1 0/206 (0.00%)  0 1/219 (0.46%)  1
Cholecystitis acute † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Infections and infestations           
Pneumonia † 1  4/655 (0.61%)  4 5/637 (0.78%)  5 6/644 (0.93%)  7 0/206 (0.00%)  0 3/219 (1.37%)  3
Abdominal hernia gangrenous † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 0/644 (0.00%)  0 0/206 (0.00%)  0 1/219 (0.46%)  1
Breast abscess † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Cellulitis † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Clostridium difficile colitis † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Sepsis † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 0/644 (0.00%)  0 0/206 (0.00%)  0 1/219 (0.46%)  1
Staphylococcal infection † 1  0/655 (0.00%)  0 1/637 (0.16%)  1 0/644 (0.00%)  0 0/206 (0.00%)  0 0/219 (0.00%)  0
Tooth abscess † 1  0/655 (0.00%)  0 1/637 (0.16%)  1 0/644 (0.00%)  0 0/206 (0.00%)  0 0/219 (0.00%)  0
Injury, poisoning and procedural complications           
Hip fracture † 1  0/655 (0.00%)  0 1/637 (0.16%)  1 0/644 (0.00%)  0 0/206 (0.00%)  0 1/219 (0.46%)  1
Acetabulum fracture † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 0/644 (0.00%)  0 0/206 (0.00%)  0 1/219 (0.46%)  1
Dural tear † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Femur fracture † 1  1/655 (0.15%)  1 0/637 (0.00%)  0 0/644 (0.00%)  0 0/206 (0.00%)  0 0/219 (0.00%)  0
Forearm fracture † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 0/644 (0.00%)  0 0/206 (0.00%)  0 1/219 (0.46%)  1
Lower limb fracture † 1  1/655 (0.15%)  1 0/637 (0.00%)  0 0/644 (0.00%)  0 0/206 (0.00%)  0 0/219 (0.00%)  0
Radius fracture † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 0/644 (0.00%)  0 1/206 (0.49%)  1 0/219 (0.00%)  0
Rib fracture † 1  1/655 (0.15%)  1 0/637 (0.00%)  0 0/644 (0.00%)  0 0/206 (0.00%)  0 0/219 (0.00%)  0
Thermal burn † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 0/644 (0.00%)  0 0/206 (0.00%)  0 1/219 (0.46%)  1
Upper limb fracture † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Vascular pseudoaneurysm † 1  1/655 (0.15%)  1 0/637 (0.00%)  0 0/644 (0.00%)  0 0/206 (0.00%)  0 0/219 (0.00%)  0
Skull fractured base † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Metabolism and nutrition disorders           
Cachexia † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 0/644 (0.00%)  0 0/206 (0.00%)  0 1/219 (0.46%)  1
Diabetes mellitus † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Diabetes with hyperosmolarity † 1  1/655 (0.15%)  1 0/637 (0.00%)  0 0/644 (0.00%)  0 0/206 (0.00%)  0 0/219 (0.00%)  0
Electrolyte imbalance † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Gout † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Osteoarthritis † 1  1/655 (0.15%)  1 0/637 (0.00%)  0 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Arthralgia † 1  0/655 (0.00%)  0 1/637 (0.16%)  2 0/644 (0.00%)  0 0/206 (0.00%)  0 0/219 (0.00%)  0
Arthritis † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Bursitis † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 0/644 (0.00%)  0 0/206 (0.00%)  0 1/219 (0.46%)  1
Musculoskeletal chest pain † 1  1/655 (0.15%)  1 0/637 (0.00%)  0 0/644 (0.00%)  0 0/206 (0.00%)  0 0/219 (0.00%)  0
Tendonitis † 1  1/655 (0.15%)  1 0/637 (0.00%)  0 0/644 (0.00%)  0 0/206 (0.00%)  0 0/219 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Adenocarcinoma of colon † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 0/644 (0.00%)  0 1/206 (0.49%)  1 0/219 (0.00%)  0
Brain cancer metastatic † 1  0/655 (0.00%)  0 1/637 (0.16%)  1 0/644 (0.00%)  0 0/206 (0.00%)  0 0/219 (0.00%)  0
Breast cancer male † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Bronchial carcinoma † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 0/644 (0.00%)  0 1/206 (0.49%)  1 0/219 (0.00%)  0
Gastric neoplasm † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Lung neoplasm malignant † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Mesothelioma † 1  1/655 (0.15%)  1 0/637 (0.00%)  0 0/644 (0.00%)  0 0/206 (0.00%)  0 0/219 (0.00%)  0
Metastases to liver † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 0/644 (0.00%)  0 1/206 (0.49%)  1 0/219 (0.00%)  0
Metastatic carcinoma of the bladder † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Non-small cell lung cancer † 1  0/655 (0.00%)  0 1/637 (0.16%)  1 0/644 (0.00%)  0 0/206 (0.00%)  0 0/219 (0.00%)  0
Pancreatic carcinoma metastatic † 1  1/655 (0.15%)  1 0/637 (0.00%)  0 0/644 (0.00%)  0 0/206 (0.00%)  0 0/219 (0.00%)  0
Prostate cancer † 1  1/655 (0.15%)  1 0/637 (0.00%)  0 0/644 (0.00%)  0 0/206 (0.00%)  0 0/219 (0.00%)  0
Transitional cell carcinoma † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 0/644 (0.00%)  0 0/206 (0.00%)  0 1/219 (0.46%)  1
Nervous system disorders           
Ischaemic stroke † 1  0/655 (0.00%)  0 1/637 (0.16%)  1 2/644 (0.31%)  2 0/206 (0.00%)  0 1/219 (0.46%)  1
Cerebrovascular accident † 1  1/655 (0.15%)  1 0/637 (0.00%)  0 1/644 (0.16%)  1 0/206 (0.00%)  0 1/219 (0.46%)  1
Transient ischaemic attack † 1  0/655 (0.00%)  0 1/637 (0.16%)  1 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Carotid artery stenosis † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Embolic stroke † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 0/644 (0.00%)  0 1/206 (0.49%)  1 0/219 (0.00%)  0
Epilepsy † 1  0/655 (0.00%)  0 1/637 (0.16%)  1 0/644 (0.00%)  0 0/206 (0.00%)  0 0/219 (0.00%)  0
Hypoaesthesia † 1  0/655 (0.00%)  0 1/637 (0.16%)  1 0/644 (0.00%)  0 0/206 (0.00%)  0 0/219 (0.00%)  0
Intracranial aneurysm † 1  0/655 (0.00%)  0 1/637 (0.16%)  1 0/644 (0.00%)  0 0/206 (0.00%)  0 0/219 (0.00%)  0
Syncope † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Product Issues           
Device battery issue † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Psychiatric disorders           
Mental status changes † 1  0/655 (0.00%)  0 1/637 (0.16%)  1 0/644 (0.00%)  0 0/206 (0.00%)  0 0/219 (0.00%)  0
Renal and urinary disorders           
Acute kidney injury † 1  1/655 (0.15%)  1 0/637 (0.00%)  0 0/644 (0.00%)  0 0/206 (0.00%)  0 0/219 (0.00%)  0
Chronic kidney disease † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Hypertonic bladder † 1  1/655 (0.15%)  1 0/637 (0.00%)  0 0/644 (0.00%)  0 0/206 (0.00%)  0 0/219 (0.00%)  0
Renal tubular necrosis † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Renal cyst † 1  1/655 (0.15%)  1 0/637 (0.00%)  0 0/644 (0.00%)  0 0/206 (0.00%)  0 0/219 (0.00%)  0
Reproductive system and breast disorders           
Prostatic haemorrhage † 1  1/655 (0.15%)  1 0/637 (0.00%)  0 0/644 (0.00%)  0 0/206 (0.00%)  0 0/219 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Chronic obstructive pulmonary disease † 1  15/655 (2.29%)  16 10/637 (1.57%)  10 29/644 (4.50%)  35 2/206 (0.97%)  2 6/219 (2.74%)  6
Acute respiratory failure † 1  2/655 (0.31%)  2 2/637 (0.31%)  2 4/644 (0.62%)  4 0/206 (0.00%)  0 1/219 (0.46%)  1
Pulmonary embolism † 1  1/655 (0.15%)  1 0/637 (0.00%)  0 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Respiratory failure † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 1/644 (0.16%)  1 0/206 (0.00%)  0 1/219 (0.46%)  1
Pleural effusion † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Vascular disorders           
Arteriosclerosis † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Haematoma † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Hypertensive emergency † 1  0/655 (0.00%)  0 1/637 (0.16%)  1 0/644 (0.00%)  0 0/206 (0.00%)  0 0/219 (0.00%)  0
Peripheral artery thrombosis † 1  0/655 (0.00%)  0 1/637 (0.16%)  1 0/644 (0.00%)  0 0/206 (0.00%)  0 0/219 (0.00%)  0
Peripheral ischaemia † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
Thrombophlebitis superficial † 1  0/655 (0.00%)  0 0/637 (0.00%)  0 1/644 (0.16%)  1 0/206 (0.00%)  0 0/219 (0.00%)  0
1
Term from vocabulary, MedDRA
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
BFF MDI 320/9.6 μg BFF MDI 160/9.6 μg FF MDI 9.6 μg BD MDI 320 μg Symbicort TBH 400/12 μg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   240/655 (36.64%)      201/637 (31.55%)      219/644 (34.01%)      75/206 (36.41%)      57/219 (26.03%)    
Gastrointestinal disorders           
Diarrhoea † 1  9/655 (1.37%)  9 9/637 (1.41%)  9 9/644 (1.40%)  9 5/206 (2.43%)  6 3/219 (1.37%)  3
General disorders           
Fatigue † 1  1/655 (0.15%)  1 1/637 (0.16%)  1 5/644 (0.78%)  5 5/206 (2.43%)  5 1/219 (0.46%)  1
Infections and infestations           
Nasopharyngitis † 1  40/655 (6.11%)  46 40/637 (6.28%)  44 43/644 (6.68%)  46 17/206 (8.25%)  18 14/219 (6.39%)  18
Upper respiratory tract infection † 1  25/655 (3.82%)  27 21/637 (3.30%)  24 20/644 (3.11%)  20 5/206 (2.43%)  7 3/219 (1.37%)  3
Chronic obstructive pulmonary disease † 1  16/655 (2.44%)  17 10/637 (1.57%)  10 30/644 (4.66%)  36 2/206 (0.97%)  2 6/219 (2.74%)  6
Oral candidiasis † 1  17/655 (2.60%)  18 14/637 (2.20%)  15 5/644 (0.78%)  6 3/206 (1.46%)  3 3/219 (1.37%)  3
Bronchitis † 1  16/655 (2.44%)  17 7/637 (1.10%)  8 10/644 (1.55%)  10 4/206 (1.94%)  4 2/219 (0.91%)  2
Sinusitis † 1  10/655 (1.53%)  12 9/637 (1.41%)  10 12/644 (1.86%)  13 2/206 (0.97%)  2 5/219 (2.28%)  5
Musculoskeletal and connective tissue disorders           
Back pain † 1  18/655 (2.75%)  21 13/637 (2.04%)  14 18/644 (2.80%)  19 3/206 (1.46%)  3 2/219 (0.91%)  2
Muscle spasms † 1  14/655 (2.14%)  15 6/637 (0.94%)  6 6/644 (0.93%)  7 0/206 (0.00%)  0 8/219 (3.65%)  8
Nervous system disorders           
Headache † 1  19/655 (2.90%)  27 8/637 (1.26%)  10 15/644 (2.33%)  15 3/206 (1.46%)  4 1/219 (0.46%)  3
Psychiatric disorders           
Anxiety † 1  6/655 (0.92%)  6 2/637 (0.31%)  2 4/644 (0.62%)  4 5/206 (2.43%)  5 1/219 (0.46%)  1
Respiratory, thoracic and mediastinal disorders           
Cough † 1  7/655 (1.07%)  8 15/637 (2.35%)  15 15/644 (2.33%)  15 7/206 (3.40%)  7 0/219 (0.00%)  0
Dyspnoea † 1  12/655 (1.83%)  12 11/637 (1.73%)  11 9/644 (1.40%)  9 7/206 (3.40%)  7 3/219 (1.37%)  3
Dysphonia † 1  16/655 (2.44%)  16 13/637 (2.04%)  13 3/644 (0.47%)  3 2/206 (0.97%)  2 1/219 (0.46%)  1
Vascular disorders           
Hypertension † 1  14/655 (2.14%)  14 22/637 (3.45%)  22 15/644 (2.33%)  15 5/206 (2.43%)  5 4/219 (1.83%)  5
1
Term from vocabulary, MedDRA
†
Indicates events were collected by systematic assessment
[Not Specified]
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.
Drafts of any and all publications or presentations of this study must be submitted at least 30 days prior to submission for publication or presentation to Pearl Therapeutics for review, approval, and to ensure consistency. Pearl Therapeutics has the right to request appropriate modification to correct facts and to represent it's opinions, or the opinions of the publication committee, if these differ with the proposed publication.
Results Point of Contact
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Name/Title: Paul M. Dorinsky, MD
Organization: Pearl Therapeutics, a Member of the AstraZeneca Group
Phone: 650-305-2600
EMail: paul.dorinsky1@astrazeneca.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02766608    
Other Study ID Numbers: PT009002
First Submitted: May 6, 2016
First Posted: May 10, 2016
Results First Submitted: November 30, 2018
Results First Posted: September 24, 2019
Last Update Posted: September 24, 2019