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Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PT001, PT003, and PT005 Following Chronic Dosing (7 Days) in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

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ClinicalTrials.gov Identifier: NCT01085045
Recruitment Status : Completed
First Posted : March 11, 2010
Results First Posted : April 26, 2017
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease
Interventions Drug: PT003 MDI
Drug: PT005 MDI
Drug: Placebo MDI
Drug: Tiotropium bromide 18 μg (Spiriva Handihaler®)
Drug: Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Drug: PT001 MDI
Enrollment 118
Recruitment Details Conducted at 16 sites in Australia, New Zealand and the US from 24 March 2010 -28 October 2010. The entire study period was a maximum of 20 weeks. Chronic dosing (7 days), 4-period, 8-treatment, incomplete block, cross-over conducted in two parts.
Pre-assignment Details Part A: 4-period, 8-treatment, incomplete block cross-over. Subjects randomized to 1 of 48 sequences, each subject received 4 of 8 possible treatments. Part B: 4-period, 4-treatment, full cross-over. Each subject randomized to 1 of 24 sequences and each sequence was assigned to at least 1 subject.
Arm/Group Title Overall Study
Hide Arm/Group Description Sentinel patients were the first 4 patients enrolled to receive one week of treatment with either GFF MDI 72/9.6mcg, GFF MDI 36/9.6 mcg, GP MDI 36 mcg or FF MDI 9.6 mcg because this was the first time GFF MDI was administered to patients with COPD, the sentinel patients provided additional assurance of safety.9.6
Period Title: Part A
Started 122
GFF MDI 72/9.6mcg 40
GFF MDI 36/9.6 µg (PT003) 42
GP MDI 36 µg (PT001) 40
Spiriva 18 µg 58
FF MDI 9.6 µg (PT005) 20
FF MDI 7.2 µg (PT005) 21
Placebo MDI 5
Foradil 12 µg 14
Completed 104
Not Completed 18
Reason Not Completed
Withdrawal by Subject             4
Adverse Event             6
Protocol Violation             1
Protocol Specified Criteria             7
Period Title: Part B
Started 104
GFF MDI 72/9.6mcg (PT003) 0
GFF MDI 36/9.6 µg 0
Spiriva 18 µg 0
FF MDI 9.6 µg (PT005) 43
FF MDI 7.2 µg (PT005) 43
Placebo MDI 47
Foradil 12 µg 41
GP MDI 36 µg (PT001) 0
Completed 89
Not Completed 15
Reason Not Completed
Withdrawal by Subject             2
Protocol Specified Criteria             6
Lost to Follow-up             1
Adverse Event             6
Arm/Group Title All Subjects
Hide Arm/Group Description All Baseline Subjects
Overall Number of Baseline Participants 122
Hide Baseline Analysis Population Description
Analysis Population included all randomized participants. 118 plus 4 sentinel patients to make 122.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 122 participants
63.4  (8.92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 122 participants
Female
53
  43.4%
Male
69
  56.6%
1.Primary Outcome
Title FEV1 AUC 0-12 on Day 7
Hide Description Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 (normalized) relative to baseline FEV1 following 7-day dose administration
Time Frame "Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 10, 11.5, and 12 hours post-dose on Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat (MITT) Population - not including the 4 sentinel patients.
Arm/Group Title GFF MDI 72/9.6 μg GFF MDI 36/9.6 μg GP MDI 36 μg Spiriva 18 μg FF MDI 9.6 μg FF MDI 7.2 μg Foradil 12 μg
Hide Arm/Group Description:
GFF MDI 72/9.6 μg (PT003)
GFF MDI 36/9.6 μg (PT003)
GP MDI 36 μg (PT001)
Spiriva 18 μg
FF MDI 9.6 μg (PT005)
FF MDI 7.2 μg (PT005)
Foradil 12 μg
Overall Number of Participants Analyzed 37 38 35 53 55 58 53
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters
1.537
(1.499 to 1.575)
1.529
(1.492 to 1.567)
1.429
(1.389 to 1.469)
1.434
(1.401 to 1.467)
1.421
(1.386 to 1.455)
1.413
(1.379 to 1.446)
1.437
(1.401 to 1.472)
2.Secondary Outcome
Title Peak Change From BL in FEV1 on Day 1
Hide Description Peak change from Baseline in FEV1 on Day 1
Time Frame Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
MITT Population - not including the 4 sentinel patients.
Arm/Group Title GFF MDI 72/9.6 μg GFF MDI 36/9.6 μg GP MDI 36 μg Spiriva 18 μg FF MDI 9.6 μg FF MDI 7.2 μg Foradil 12 μg
Hide Arm/Group Description:
GFF MDI 72/9.6 μg (PT003)
GFF MDI 36/9.6 μg (PT003)
GP MDI 36 μg (PT001)
Spiriva 18 μg
FF MDI 9.6 μg (PT005)
FF MDI 7.2 μg (PT005)
Foradil 12 μg
Overall Number of Participants Analyzed 38 39 38 56 58 63 54
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters
0.370
(0.325 to 0.416)
0.357
(0.312 to 0.401)
0.289
(0.243 to 0.335)
0.266
(0.229 to 0.304)
0.308
(0.269 to 0.348)
0.310
(0.273 to 0.348)
0.299
(0.258 to 0.340)
3.Secondary Outcome
Title Peak Change From BL in FEV1 on Day 7
Hide Description Peak change from Baseline (BL) in FEV1 on Day 7
Time Frame Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
MITT Population - not including the 4 sentinel patients.
Arm/Group Title GFF MDI 72/9.6 μg GFF MDI 36/9.6 μg GP MDI 36 μg Spiriva 18 μg FF MDI 9.6 μg FF MDI 7.2 μg Foradil 12 μg
Hide Arm/Group Description:
GFF MDI 72/9.6 μg (PT003)
GFF MDI 36/9.6 μg (PT003)
GP MDI 36 μg (PT001)
Spiriva 18 μg
FF MDI 9.6 μg (PT005)
FF MDI 7.2 μg (PT005)
Foradil 12 μg
Overall Number of Participants Analyzed 38 39 38 53 58 61 54
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters
0.438
(0.396 to 0.481)
0.440
(0.398 to 0.481)
0.313
(0.270 to 0.356)
0.298
(0.262 to 0.335)
0.337
(0.300 to 0.374)
0.330
(0.294 to 0.366)
0.356
(0.317 to 0.395)
4.Secondary Outcome
Title Peak Change From BL in Inspiratory Capacity on Day 1
Hide Description Peak change from Baseline in Inspiratory Capacity (IC) on Day 1
Time Frame Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
MITT Population - not including the 4 sentinel patients.
Arm/Group Title GFF MDI 72/9.6 μg GFF MDI 36/9.6 μg GP MDI 36 μg Spiriva 18 μg FF MDI 9.6 μg FF MDI 7.2 μg Foradil 12 μg
Hide Arm/Group Description:
GFF MDI 72/9.6 μg (PT003)
GFF MDI 36/9.6 μg (PT003)
GP MDI 36 μg (PT001)
Spiriva 18 μg
FF MDI 9.6 μg (PT005)
FF MDI 7.2 μg (PT005)
Foradil 12 μg
Overall Number of Participants Analyzed 38 39 38 56 58 63 54
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters
0.495
(0.411 to 0.579)
0.411
(0.330 to 0.493)
0.430
(0.346 to 0.514)
0.347
(0.278 to 0.416)
0.362
(0.290 to 0.433)
0.352
(0.283 to 0.420)
0.374
(0.299 to 0.449)
5.Secondary Outcome
Title Peak Change From BL IC on Day 7
Hide Description Peak Change from Baseline Inspiratory Capacity on following 7-day dose administration
Time Frame Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
MITT Population - not including the 4 sentinel patients.
Arm/Group Title GFF MDI 72/9.6 μg GFF MDI 36/9.6 μg GP MDI 36 μg Spiriva 18 μg FF MDI 9.6 μg FF MDI 7.2 μg Foradil 12 μg
Hide Arm/Group Description:
GFF MDI 72/9.6 μg (PT003)
GFF MDI 36/9.6 μg (PT003)
GP MDI 36 μg (PT001)
Spiriva 18 μg
FF MDI 9.6 μg (PT005)
FF MDI 7.2 μg (PT005)
Foradil 12 μg
Overall Number of Participants Analyzed 37 39 38 53 58 61 54
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters
0.409
(0.327 to 0.491)
0.438
(0.359 to 0.516)
0.331
(0.249 to 0.412)
0.314
(0.244 to 0.383)
0.359
(0.289 to 0.430)
0.376
(0.307 to 0.444)
0.393
(0.319 to 0.466)
6.Secondary Outcome
Title Time to Onset of Action >=10% Improvement in FEV1 on Day 1
Hide Description Time to Onset of Action where the improvement in FEV1 on Day 1 was >=10%
Time Frame Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
MITT Population - not including the 4 sentinel patients.
Arm/Group Title GFF MDI 72/9.6 μg GFF MDI 36/9.6 μg GP MDI 36 μg Spiriva 18 μg FF MDI 9.6 μg FF MDI 7.2 μg Foradil 12 μg
Hide Arm/Group Description:
GFF MDI 72/9.6 μg (PT003)
GFF MDI 36/9.6 μg (PT003)
GP MDI 36 μg (PT001)
Spiriva 18 μg
FF MDI 9.6 μg (PT005)
FF MDI 7.2 μg (PT005)
Foradil 12 μg
Overall Number of Participants Analyzed 36 39 37 54 57 61 50
Measure Type: Number
Unit of Measure: Participants
15 Minutes 22 20 14 22 37 34 30
30 Minutes 5 7 10 4 10 12 6
60 Minutes 4 6 3 7 4 4 6
120 Minutes 2 1 4 5 0 2 3
No onset 3 5 6 16 6 9 5
7.Secondary Outcome
Title Percentage of Patients Achieving >=12% Improvement in FEV1 on Day 1
Hide Description Time to Onset of Action where the improvement in FEV1 on Day 1 was >= 12%
Time Frame Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
MITT Population - not including the 4 sentinel patients.
Arm/Group Title GFF MDI 72/9.6 μg GFF MDI 36/9.6 μg GP MDI 36 μg Spiriva 18 μg FF MDI 9.6 μg FF MDI 7.2 μg Foradil 12 μg
Hide Arm/Group Description:
GFF MDI 72/9.6 μg (PT003)
GFF MDI 36/9.6 μg (PT003)
GP MDI 36 μg (PT001)
Spiriva 18 μg
FF MDI 9.6 μg (PT005)
FF MDI 7.2 μg (PT005)
Foradil 12 μg
Overall Number of Participants Analyzed 38 39 38 56 58 63 54
Measure Type: Number
Unit of Measure: Percentage of Participants
86.84 87.18 73.68 66.07 84.48 82.54 85.19
8.Secondary Outcome
Title Change in Morning Pre-dose FEV1 on Day 7
Hide Description Change from Baseline in morning pre-dose FEV1 on Day 7
Time Frame Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
MITT Population - not including the 4 sentinel patients.
Arm/Group Title GFF MDI 72/9.6 μg GFF MDI 36/9.6 μg GP MDI 36 μg Spiriva 18 μg FF MDI 9.6 μg FF MDI 7.2 μg Foradil 12 μg
Hide Arm/Group Description:
GFF MDI 72/9.6 μg (PT003)
GFF MDI 36/9.6 μg (PT003)
GP MDI 36 μg (PT001)
Spiriva 18 μg
FF MDI 9.6 μg (PT005)
FF MDI 7.2 μg (PT005)
Foradil 12 μg
Overall Number of Participants Analyzed 38 39 38 53 58 61 54
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters
0.193
(0.148 to 0.237)
0.170
(0.126 to 0.213)
0.097
(0.052 to 0.142)
0.097
(0.058 to 0.136)
0.064
(0.024 to 0.103)
0.073
(0.034 to 0.111)
0.101
(0.060 to 0.142)
9.Secondary Outcome
Title 12 hr Post-dose Trough FEV1 on Day 7
Hide Description 12 hour post-dose trough Forced Expiratory Volume in 1 second on Day 7
Time Frame Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
MITT Population - not including the 4 sentinel patients.
Arm/Group Title GFF MDI 72/9.6 μg GFF MDI 36/9.6 μg GP MDI 36 μg Spiriva 18 μg FF MDI 9.6 μg FF MDI 7.2 μg Foradil 12 μg
Hide Arm/Group Description:
GFF MDI 72/9.6 μg (PT003)
GFF MDI 36/9.6 μg (PT003)
GP MDI 36 μg (PT001)
Spiriva 18 μg
FF MDI 9.6 μg (PT005)
FF MDI 7.2 μg (PT005)
Foradil 12 μg
Overall Number of Participants Analyzed 37 38 35 53 55 58 53
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters
1.405
(1.358 to 1.453)
1.441
(1.395 to 1.488)
1.383
(1.333 to 1.432)
1.398
(1.357 to 1.439)
1.349
(1.306 to 1.393)
1.378
(1.336 to 1.419)
1.358
(1.314 to 1.402)
10.Secondary Outcome
Title Change From BL in Mean Morning Pre-dose Daily Peak Flow Rate on Day 7
Hide Description Change from BaseLine in mean morning pre-dose daily peak flow rate on Day 7
Time Frame Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
MITT Population - not including the 4 sentinel patients.
Arm/Group Title GFF MDI 72/9.6 μg GFF MDI 36/9.6 μg GP MDI 36 μg Spiriva 18 μg FF MDI 9.6 μg FF MDI 7.2 μg Foradil 12 μg
Hide Arm/Group Description:
GFF MDI 72/9.6 μg (PT003)
GFF MDI 36/9.6 μg (PT003)
GP MDI 36 μg (PT001)
Spiriva 18 μg
FF MDI 9.6 μg (PT005)
FF MDI 7.2 μg (PT005)
Foradil 12 μg
Overall Number of Participants Analyzed 38 39 38 54 56 60 52
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters / Minute
30.263
(21.479 to 39.046)
28.152
(19.756 to 36.547)
16.439
(7.620 to 25.259)
11.817
(4.316 to 19.317)
12.424
(4.593 to 20.256)
10.211
(2.692 to 17.730)
13.426
(5.426 to 21.426)
11.Secondary Outcome
Title Change From BL in Mean Morning Post-dose Daily Peak Flow Rate on Day 7
Hide Description Change from BaseLine in mean morning post-dose daily peak flow rate on Day 7
Time Frame Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
MITT Population - not including the 4 sentinel patients.
Arm/Group Title GFF MDI 72/9.6 μg GFF MDI 36/9.6 μg GP MDI 36 μg Spiriva 18 μg FF MDI 9.6 μg FF MDI 7.2 μg Foradil 12 μg
Hide Arm/Group Description:
GFF MDI 72/9.6 μg (PT003)
GFF MDI 36/9.6 μg (PT003)
GP MDI 36 μg (PT001)
Spiriva 18 μg
FF MDI 9.6 μg (PT005)
FF MDI 7.2 μg (PT005)
Foradil 12 μg
Overall Number of Participants Analyzed 38 39 38 54 56 60 52
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters / Minute
56.666
(47.631 to 65.700)
53.411
(44.600 to 62.221)
33.652
(24.553 to 42.750)
27.668
(19.742 to 35.594)
41.287
(33.105 to 49.468)
38.712
(30.799 to 46.624)
39.132
(30.761 to 47.502)
12.Secondary Outcome
Title Change From BL in Mean Evening Pre-dose Daily Peak Flow Rate on Day 7
Hide Description Change from BaseLine in mean evening pre-dose daily peak flow rate on Day 7
Time Frame Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
MITT Population - not including the 4 sentinel patients.
Arm/Group Title GFF MDI 72/9.6 μg GFF MDI 36/9.6 μg GP MDI 36 μg FF MDI 9.6 μg FF MDI 7.2 μg Foradil 12 μg
Hide Arm/Group Description:
GFF MDI 72/9.6 μg (PT003)
GFF MDI 36/9.6 μg (PT003)
GP MDI 36 μg (PT001)
FF MDI 9.6 μg (PT005)
FF MDI 7.2 μg (PT005)
Foradil 12 μg
Overall Number of Participants Analyzed 38 39 38 56 60 52
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters / Minute
35.0945
(25.888 to 44.302)
30.817
(21.713 to 39.920)
18.487
(9.034 to 27.939)
17.190
(9.029 to 25.350)
14.805
(6.800 to 22.810)
17.789
(9.383 to 26.194)
13.Secondary Outcome
Title Change From BL in Mean Evening Post-dose Daily Peak Flow Rate on Day 7
Hide Description Change from BaseLine in mean evening post-dose daily peak flow rate on Day 7
Time Frame Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
MITT Population - not including the 4 sentinel patients.
Arm/Group Title GFF MDI 72/9.6 μg GFF MDI 36/9.6 μg GP MDI 36 μg Spiriva 18 μg FF MDI 9.6 μg FF MDI 7.2 μg Foradil 12 μg
Hide Arm/Group Description:
GFF MDI 72/9.6 μg (PT003)
GFF MDI 36/9.6 μg (PT003)
GP MDI 36 μg (PT001)
Spiriva 18 μg
FF MDI 9.6 μg (PT005)
FF MDI 7.2 μg (PT005)
Foradil 12 μg
Overall Number of Participants Analyzed 38 39 38 51 56 59 52
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters / Minute
53.863
(43.924 to 63.802)
58.326
(48.553 to 68.099)
36.637
(26.685 to 46.589)
24.253
(15.172 to 33.335)
41.395
(32.252 to 50.538)
37.192
(28.251 to 46.132)
39.323
(30.024 to 48.621)
Time Frame Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Adverse Event Reporting Description Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
 
Arm/Group Title GP/FF MDI 72/9.6 μg GP/FF MDI 36/9.6 μg GP MDI 36 μg Spiriva FF MDI 9.6 μg FF MDI 7.2 μg Placebo Foradil Aerolizer
Hide Arm/Group Description GP/FF MDI 72/9.6 μg (PT003) GP/FF MDI 36/9.6 μg (PT003) GP MDI 36 μg (PT001) Handihaler 18 μg FF MDI 9.6 μg (PT005) FF MDI 7.2 μg (PT005) Placebo MDI Foradil Aerolizer 12 μg
All-Cause Mortality
GP/FF MDI 72/9.6 μg GP/FF MDI 36/9.6 μg GP MDI 36 μg Spiriva FF MDI 9.6 μg FF MDI 7.2 μg Placebo Foradil Aerolizer
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
GP/FF MDI 72/9.6 μg GP/FF MDI 36/9.6 μg GP MDI 36 μg Spiriva FF MDI 9.6 μg FF MDI 7.2 μg Placebo Foradil Aerolizer
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/41 (0.00%)      1/43 (2.33%)      0/41 (0.00%)      2/58 (3.45%)      1/64 (1.56%)      2/64 (3.13%)      0/52 (0.00%)      0/55 (0.00%)    
Gastrointestinal disorders                 
Gastritis  1  0/41 (0.00%)  0 0/43 (0.00%)  0 0/41 (0.00%)  0 0/58 (0.00%)  0 1/64 (1.56%)  1 0/64 (0.00%)  0 0/52 (0.00%)  0 0/55 (0.00%)  0
General disorders                 
Chest pain  1  0/41 (0.00%)  0 0/43 (0.00%)  0 0/41 (0.00%)  0 0/58 (0.00%)  0 0/64 (0.00%)  0 1/64 (1.56%)  1 0/52 (0.00%)  0 0/55 (0.00%)  0
Infections and infestations                 
Appendicitis perforated  1  0/41 (0.00%)  0 1/43 (2.33%)  1 0/41 (0.00%)  0 0/58 (0.00%)  0 0/64 (0.00%)  0 0/64 (0.00%)  0 0/52 (0.00%)  0 0/55 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                 
Chronic obstructive pulmonary disease  1  0/41 (0.00%)  0 0/43 (0.00%)  0 0/41 (0.00%)  0 0/58 (0.00%)  0 0/64 (0.00%)  0 1/64 (1.56%)  1 0/52 (0.00%)  0 0/55 (0.00%)  0
Foreign Body Aspiration  1  0/41 (0.00%)  0 0/43 (0.00%)  0 0/41 (0.00%)  0 1/58 (1.72%)  1 0/64 (0.00%)  0 0/64 (0.00%)  0 0/52 (0.00%)  0 0/55 (0.00%)  0
Vascular disorders                 
Aortic aneurysm  1  0/41 (0.00%)  0 0/43 (0.00%)  0 0/41 (0.00%)  0 1/58 (1.72%)  1 0/64 (0.00%)  0 0/64 (0.00%)  0 0/52 (0.00%)  0 0/55 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GP/FF MDI 72/9.6 μg GP/FF MDI 36/9.6 μg GP MDI 36 μg Spiriva FF MDI 9.6 μg FF MDI 7.2 μg Placebo Foradil Aerolizer
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/41 (34.15%)      17/43 (39.53%)      10/41 (24.39%)      9/58 (15.52%)      5/64 (7.81%)      4/64 (6.25%)      4/52 (7.69%)      7/55 (12.73%)    
Gastrointestinal disorders                 
Dry Mouth  1  8/41 (19.51%)  10 3/43 (6.98%)  5 6/41 (14.63%)  7 5/58 (8.62%)  6 3/64 (4.69%)  4 3/64 (4.69%)  4 1/52 (1.92%)  1 3/55 (5.45%)  4
Nervous system disorders                 
Headache  1  5/41 (12.20%)  6 5/43 (11.63%)  19 2/41 (4.88%)  2 1/58 (1.72%)  1 1/64 (1.56%)  1 0/64 (0.00%)  0 1/52 (1.92%)  1 3/55 (5.45%)  3
Tremor  1  1/41 (2.44%)  1 6/43 (13.95%)  8 1/41 (2.44%)  1 1/58 (1.72%)  1 0/64 (0.00%)  0 1/64 (1.56%)  1 0/52 (0.00%)  0 0/55 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                 
Cough  1  0/41 (0.00%)  0 3/43 (6.98%)  3 1/41 (2.44%)  1 2/58 (3.45%)  2 1/64 (1.56%)  1 0/64 (0.00%)  0 2/52 (3.85%)  2 1/55 (1.82%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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 its opinions, or the opinions of the publication committee, if these differ with the proposed publication.
Results Point of Contact
Name/Title: Colin Reisner, MD, FCCP, FAAAAI
Organization: Pearl Therapeutics, Inc
Phone: 650-305-2600
Responsible Party: Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01085045     History of Changes
Other Study ID Numbers: PT0031002
First Submitted: March 9, 2010
First Posted: March 11, 2010
Results First Submitted: May 24, 2016
Results First Posted: April 26, 2017
Last Update Posted: April 26, 2017