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Trial record 55 of 185 for:    GLYCOPYRROLATE

Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD (PINNACLE 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01854658
Recruitment Status : Completed
First Posted : May 15, 2013
Results First Posted : March 28, 2017
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease (COPD)
Interventions Drug: GFF MDI (PT003)
Drug: GP MDI (PT001)
Drug: FF MDI (PT005)
Drug: Placebo
Enrollment 1615
Recruitment Details Conducted at 140 sites throughout the United States from July 2013 - February 2015. Study participation was a maximum of 32 weeks.
Pre-assignment Details A multicenter, randomized, double-blind, parallel group, chronic dosing, active- and placebo-controlled study; each participant was randomized to receive 1 of 4 possible treatments over the course of a 24-week treatment period (With a randomization of 7:6:6:3 GFF MDI, GP MDI, FF MDI and Placebo MDI)
Arm/Group Title FF MDI (PT005) GP MDI (PT001) GFF MDI (PT003) Placebo MDI
Hide Arm/Group Description FF MDI 9.6 mcg administered as two puffs BID GP MDI 14.4 mcg administered as two puffs BID GFF MDI 14.4/9.6 mcg administered as two puffs BID Inhaled placebo administered as two puffs BID
Period Title: Overall Study
Started 439 440 512 224
Completed 346 365 432 165
Not Completed 93 75 80 59
Reason Not Completed
Protocol Violation             6             2             2             1
Physician Decision             7             5             2             4
Lost to Follow-up             8             9             8             4
Withdrawal by Subject             28             21             29             15
Protocol-specified criteria             15             15             10             7
Lack of Efficacy             3             8             4             7
Adverse Event             21             14             23             19
Administrative reasons             5             1             2             2
Arm/Group Title FF MDI (PT005) GP MDI (PT001) GFF MDI (PT003) Placebo MDI Total
Hide Arm/Group Description FF MDI 9.6 mcg administered as two puffs BID GP MDI 14.4 mcg administered as two puffs BID GFF MDI 14.4/9.6 mcg administered as two puffs BID Inhaled placebo administered as two puffs BID Total of all reporting groups
Overall Number of Baseline Participants 437 439 510 223 1609
Hide Baseline Analysis Population Description
5 subjects participated in more than one Phase 3 Pearl study (a protocol violation) and had overlapping treatment exposure - these subjects were removed from the ITT and safety populations; 1 subject participated in more than one Phase 3 Pearl study but did not have overlapping treatment exposure - this subject was removed from the ITT population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 437 participants 439 participants 510 participants 223 participants 1609 participants
62.6  (7.8) 62.8  (8.4) 62.8  (8.2) 64.2  (8.7) 62.9  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 437 participants 439 participants 510 participants 223 participants 1609 participants
Female
190
  43.5%
197
  44.9%
238
  46.7%
98
  43.9%
723
  44.9%
Male
247
  56.5%
242
  55.1%
272
  53.3%
125
  56.1%
886
  55.1%
1.Primary Outcome
Title Change From Baseline in Morning Pre-dose Trough FEV1
Hide Description Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) at Week 24.
Time Frame At Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population with evaluable data (no imputation) for this outcome measure.
Arm/Group Title FF MDI (PT005) GP MDI (PT001) GFF MDI (PT003) Placebo MDI
Hide Arm/Group Description:
FF MDI 9.6 mcg administered as two puffs BID
GP MDI 14.4 mcg administered as two puffs BID
GFF MDI 14.4/9.6 mcg administered as two puffs BID
Inhaled placebo administered as two puffs BID
Overall Number of Participants Analyzed 350 367 433 170
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters
0.061
(0.039 to 0.082)
0.063
(0.041 to 0.084)
0.116
(0.097 to 0.136)
0.013
(-0.018 to 0.044)
2.Secondary Outcome
Title Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks
Hide Description Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) over 24 weeks. FEV1 was assessed at multiple time points post-baseline, and a model-based average of all visits starting from Week 2 through week 24 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average FEV1 post-baseline.
Time Frame Over 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population with evaluable data (no imputation) for this outcome measure.
Arm/Group Title FF MDI (PT005) GP MDI (PT001) GFF MDI (PT003) Placebo MDI
Hide Arm/Group Description:
FF MDI 9.6 mcg administered as two puffs BID
GP MDI 14.4 mcg administered as two puffs BID
GFF MDI 14.4/9.6 mcg administered as two puffs BID
Inhaled placebo administered as two puffs BID
Overall Number of Participants Analyzed 434 434 503 216
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters
0.080
(0.064 to 0.095)
0.082
(0.067 to 0.097)
0.137
(0.123 to 0.151)
0.008
(-0.014 to 0.030)
3.Secondary Outcome
Title Peak FEV1
Hide Description Peak change from baseline in FEV1 within 2 hours post-dosing at Week 24
Time Frame At week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population with evaluable data (no imputation) for this outcome measure.
Arm/Group Title FF MDI (PT005) GP MDI (PT001) GFF MDI (PT003) Placebo MDI
Hide Arm/Group Description:
FF MDI 9.6 mcg administered as two puffs BID
GP MDI 14.4 mcg administered as two puffs BID
GFF MDI 14.4/9.6 mcg administered as two puffs BID
Inhaled placebo administered as two puffs BID
Overall Number of Participants Analyzed 346 365 431 165
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters
0.268
(0.244 to 0.292)
0.223
(0.199 to 0.247)
0.350
(0.328 to 0.371)
0.083
(0.048 to 0.117)
4.Secondary Outcome
Title St. George Respiratory Questionnaire (SGRQ) Score
Hide Description Change from baseline in the SGRQ total score at Week 24. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI 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 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population with evaluable data (no imputation) for this outcome measure.
Arm/Group Title FF MDI (PT005) GP MDI (PT001) GFF MDI (PT003) Placebo MDI
Hide Arm/Group Description:
FF MDI 9.6 mcg administered as two puffs BID
GP MDI 14.4 mcg administered as two puffs BID
GFF MDI 14.4/9.6 mcg administered as two puffs BID
Inhaled placebo administered as two puffs BID
Overall Number of Participants Analyzed 352 362 430 170
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
-2.3
(-3.5 to -1.1)
-2.2
(-3.4 to -1.0)
-3.0
(-4.1 to -1.8)
-1.2
(-3.0 to 0.5)
5.Secondary Outcome
Title Rescue Ventolin HFA Use
Hide Description Change from baseline in average daily rescue Ventolin HFA use over 24 weeks
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population with evaluable data (no imputation) for this outcome measure.
Arm/Group Title FF MDI (PT005) GP MDI (PT001) GFF MDI (PT003) Placebo MDI
Hide Arm/Group Description:
FF MDI 9.6 mcg administered as two puffs BID
GP MDI 14.4 mcg administered as two puffs BID
GFF MDI 14.4/9.6 mcg administered as two puffs BID
Inhaled placebo administered as two puffs BID
Overall Number of Participants Analyzed 437 438 510 223
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Puffs / Day
-0.7
(-0.9 to -0.5)
-0.4
(-0.6 to -0.3)
-1.0
(-1.2 to -0.8)
0.0
(-0.2 to 0.3)
6.Secondary Outcome
Title Onset of Action as Assessed by FEV1
Hide Description Defined as the first time-point using the 5- and 15-minute post dose measurements where the difference in FEV1 from Placebo was statistically significant
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population with evaluable data (no imputation) for this outcome measure.
Arm/Group Title FF MDI (PT005) GP MDI (PT001) GFF MDI (PT003) Placebo MDI
Hide Arm/Group Description:
FF MDI 9.6 mcg administered as two puffs BID
GP MDI 14.4 mcg administered as two puffs BID
GFF MDI 14.4/9.6 mcg administered as two puffs BID
Inhaled placebo administered as two puffs BID
Overall Number of Participants Analyzed 375 371 429 179
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters
5 min post dose
0.175
(0.163 to 0.188)
0.052
(0.040 to 0.065)
0.192
(0.180 to 0.204)
0.006
(-0.012 to 0.024)
15 min post dose
0.212
(0.199 to 0.225)
0.109
(0.096 to 0.122)
0.237
(0.225 to 0.249)
0.022
(0.003 to 0.040)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FF MDI (PT005), Placebo MDI
Comments At 5 min post dose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FF MDI (PT005), Placebo MDI
Comments At 15 min post dose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GP MDI (PT001), Placebo MDI
Comments At 5 min post dose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GP MDI (PT001), Placebo MDI
Comments At 15 min post dose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection GFF MDI (PT003), Placebo MDI
Comments At 5 min post dose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection GFF MDI (PT003), Placebo MDI
Comments At 15 min post dose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame Adverse events (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.
Adverse Event Reporting Description Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received
 
Arm/Group Title FF MDI (PT005) GP MDI (PT001) GFF MDI (PT003) Placebo MDI
Hide Arm/Group Description FF MDI 9.6 mcg administered as two puffs BID GP MDI 14.4 mcg administered as two puffs BID GFF MDI 14.4/9.6 mcg administered as two puffs BID Inhaled placebo administered as two puffs BID
All-Cause Mortality
FF MDI (PT005) GP MDI (PT001) GFF MDI (PT003) Placebo MDI
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
FF MDI (PT005) GP MDI (PT001) GFF MDI (PT003) Placebo MDI
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   37/438 (8.45%)      37/439 (8.43%)      36/510 (7.06%)      15/223 (6.73%)    
Blood and lymphatic system disorders         
Anaemia  1  0/438 (0.00%)  0 0/439 (0.00%)  0 0/510 (0.00%)  0 1/223 (0.45%)  1
Cardiac disorders         
Atrial fibrillation  1  0/438 (0.00%)  0 2/439 (0.46%)  3 3/510 (0.59%)  3 0/223 (0.00%)  0
Acute myocardial infarction  1  1/438 (0.23%)  1 1/439 (0.23%)  1 1/510 (0.20%)  1 0/223 (0.00%)  0
Cardiac failure congestive  1  0/438 (0.00%)  0 2/439 (0.46%)  2 0/510 (0.00%)  0 0/223 (0.00%)  0
Myocardial infarction  1  0/438 (0.00%)  0 0/439 (0.00%)  0 0/510 (0.00%)  0 2/223 (0.90%)  2
Angina pectoris  1  0/438 (0.00%)  0 0/439 (0.00%)  0 1/510 (0.20%)  1 0/223 (0.00%)  0
Atrial flutter  1  0/438 (0.00%)  0 1/439 (0.23%)  1 0/510 (0.00%)  0 0/223 (0.00%)  0
Atrioventricular block  1  1/438 (0.23%)  1 0/439 (0.00%)  0 0/510 (0.00%)  0 0/223 (0.00%)  0
Atrioventricular block second degree  1  0/438 (0.00%)  0 1/439 (0.23%)  1 0/510 (0.00%)  0 0/223 (0.00%)  0
Bradycardia  1  0/438 (0.00%)  0 1/439 (0.23%)  1 0/510 (0.00%)  0 0/223 (0.00%)  0
Cardiac failure acute  1  0/438 (0.00%)  0 0/439 (0.00%)  0 1/510 (0.20%)  1 0/223 (0.00%)  0
Coronary artery stenosis  1  0/438 (0.00%)  0 0/439 (0.00%)  0 1/510 (0.20%)  1 0/223 (0.00%)  0
Myocardial ischaemia  1  0/438 (0.00%)  0 0/439 (0.00%)  0 1/510 (0.20%)  1 0/223 (0.00%)  0
Ventricular fibrillation  1  1/438 (0.23%)  1 0/439 (0.00%)  0 0/510 (0.00%)  0 0/223 (0.00%)  0
Ear and labyrinth disorders         
Vertigo  1  1/438 (0.23%)  1 0/439 (0.00%)  0 0/510 (0.00%)  0 0/223 (0.00%)  0
Gastrointestinal disorders         
Intestinal obstruction  1  0/438 (0.00%)  0 2/439 (0.46%)  2 0/510 (0.00%)  0 0/223 (0.00%)  0
Small intestinal obstruction  1  2/438 (0.46%)  2 0/439 (0.00%)  0 0/510 (0.00%)  0 0/223 (0.00%)  0
Abdominal mass  1  0/438 (0.00%)  0 1/439 (0.23%)  1 0/510 (0.00%)  0 0/223 (0.00%)  0
Abdominal pain upper  1  0/438 (0.00%)  0 0/439 (0.00%)  0 1/510 (0.20%)  1 0/223 (0.00%)  0
Gastrointestinal haemorrhage  1  1/438 (0.23%)  1 0/439 (0.00%)  0 0/510 (0.00%)  0 0/223 (0.00%)  0
Ileus  1  1/438 (0.23%)  1 0/439 (0.00%)  0 0/510 (0.00%)  0 0/223 (0.00%)  0
Nausea  1  0/438 (0.00%)  0 0/439 (0.00%)  0 1/510 (0.20%)  1 0/223 (0.00%)  0
Oesophageal ulcer  1  1/438 (0.23%)  1 0/439 (0.00%)  0 0/510 (0.00%)  0 0/223 (0.00%)  0
Pancreatic mass  1  0/438 (0.00%)  0 0/439 (0.00%)  0 1/510 (0.20%)  1 0/223 (0.00%)  0
Pancreatitis acute  1  0/438 (0.00%)  0 0/439 (0.00%)  0 1/510 (0.20%)  1 0/223 (0.00%)  0
Upper gastrointestinal haemorrhage  1  0/438 (0.00%)  0 1/439 (0.23%)  1 0/510 (0.00%)  0 0/223 (0.00%)  0
General disorders         
Chest pain  1  1/438 (0.23%)  1 1/439 (0.23%)  1 1/510 (0.20%)  1 0/223 (0.00%)  0
Non-cardiac chest pain  1  2/438 (0.46%)  2 0/439 (0.00%)  0 1/510 (0.20%)  1 0/223 (0.00%)  0
Death  1  0/438 (0.00%)  0 0/439 (0.00%)  0 1/510 (0.20%)  1 1/223 (0.45%)  1
Chest discomfort  1  0/438 (0.00%)  0 0/439 (0.00%)  0 1/510 (0.20%)  1 0/223 (0.00%)  0
Hepatobiliary disorders         
Cholecystitis acute  1  1/438 (0.23%)  1 0/439 (0.00%)  0 0/510 (0.00%)  0 0/223 (0.00%)  0
Cholelithiasis  1  0/438 (0.00%)  0 0/439 (0.00%)  0 0/510 (0.00%)  0 1/223 (0.45%)  1
Hepatic steatosis  1  0/438 (0.00%)  0 1/439 (0.23%)  1 0/510 (0.00%)  0 0/223 (0.00%)  0
Infections and infestations         
Pneumonia  1  4/438 (0.91%)  4 4/439 (0.91%)  4 2/510 (0.39%)  2 3/223 (1.35%)  3
Sepsis  1  0/438 (0.00%)  0 1/439 (0.23%)  1 0/510 (0.00%)  0 1/223 (0.45%)  1
Urinary tract infection  1  0/438 (0.00%)  0 0/439 (0.00%)  0 1/510 (0.20%)  1 1/223 (0.45%)  1
Bronchitis  1  0/438 (0.00%)  0 0/439 (0.00%)  0 0/510 (0.00%)  0 1/223 (0.45%)  1
Cellulitis staphylococcal  1  0/438 (0.00%)  0 1/439 (0.23%)  1 0/510 (0.00%)  0 0/223 (0.00%)  0
Diverticulitis  1  1/438 (0.23%)  1 0/439 (0.00%)  0 0/510 (0.00%)  0 0/223 (0.00%)  0
Extradural abscess  1  1/438 (0.23%)  1 0/439 (0.00%)  0 0/510 (0.00%)  0 0/223 (0.00%)  0
Pneumonia bacterial  1  0/438 (0.00%)  0 1/439 (0.23%)  1 0/510 (0.00%)  0 0/223 (0.00%)  0
Pneumonia pneumococcal  1  1/438 (0.23%)  1 0/439 (0.00%)  0 0/510 (0.00%)  0 0/223 (0.00%)  0
Pyelonephritis  1  0/438 (0.00%)  0 0/439 (0.00%)  0 1/510 (0.20%)  1 0/223 (0.00%)  0
Septic shock  1  0/438 (0.00%)  0 0/439 (0.00%)  0 1/510 (0.20%)  1 0/223 (0.00%)  0
Urosepsis  1  0/438 (0.00%)  0 0/439 (0.00%)  0 1/510 (0.20%)  1 0/223 (0.00%)  0
Injury, poisoning and procedural complications         
Rib fracture  1  1/438 (0.23%)  1 1/439 (0.23%)  1 0/510 (0.00%)  0 1/223 (0.45%)  1
Ankle fracture  1  0/438 (0.00%)  0 1/439 (0.23%)  1 0/510 (0.00%)  0 0/223 (0.00%)  0
Fibula fracture  1  1/438 (0.23%)  1 0/439 (0.00%)  0 0/510 (0.00%)  0 0/223 (0.00%)  0
Hip fracture  1  0/438 (0.00%)  0 0/439 (0.00%)  0 1/510 (0.20%)  1 0/223 (0.00%)  0
Investigations         
Electrocardiogram QT prolonged  1  0/438 (0.00%)  0 1/439 (0.23%)  1 0/510 (0.00%)  0 0/223 (0.00%)  0
Metabolism and nutrition disorders         
Hypoglycaemia  1  0/438 (0.00%)  0 1/439 (0.23%)  1 0/510 (0.00%)  0 0/223 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Osteoarthritis  1  0/438 (0.00%)  0 0/439 (0.00%)  0 1/510 (0.20%)  1 1/223 (0.45%)  1
Lumbar spinal stenosis  1  0/438 (0.00%)  0 0/439 (0.00%)  0 1/510 (0.20%)  1 0/223 (0.00%)  0
Vertebral foraminal stenosis  1  1/438 (0.23%)  1 0/439 (0.00%)  0 0/510 (0.00%)  0 0/223 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Lung adenocarcinoma  1  2/438 (0.46%)  2 0/439 (0.00%)  0 0/510 (0.00%)  0 1/223 (0.45%)  1
Lung neoplasm malignant  1  1/438 (0.23%)  1 0/439 (0.00%)  0 2/510 (0.39%)  2 0/223 (0.00%)  0
Bladder cancer  1  0/438 (0.00%)  0 0/439 (0.00%)  0 1/510 (0.20%)  1 0/223 (0.00%)  0
Bladder neoplasm  1  0/438 (0.00%)  0 1/439 (0.23%)  1 0/510 (0.00%)  0 0/223 (0.00%)  0
Hepatic cancer  1  0/438 (0.00%)  0 0/439 (0.00%)  0 1/510 (0.20%)  1 0/223 (0.00%)  0
Non-small cell lung cancer  1  1/438 (0.23%)  1 0/439 (0.00%)  0 0/510 (0.00%)  0 0/223 (0.00%)  0
Oropharyngeal squamous cell carcinoma  1  0/438 (0.00%)  0 1/439 (0.23%)  1 0/510 (0.00%)  0 0/223 (0.00%)  0
Pancreatic carcinoma  1  0/438 (0.00%)  0 0/439 (0.00%)  0 1/510 (0.20%)  1 0/223 (0.00%)  0
Rectal adenocarcinoma  1  1/438 (0.23%)  1 0/439 (0.00%)  0 0/510 (0.00%)  0 0/223 (0.00%)  0
Transitional cell carcinoma  1  0/438 (0.00%)  0 1/439 (0.23%)  1 0/510 (0.00%)  0 0/223 (0.00%)  0
Nervous system disorders         
Syncope  1  0/438 (0.00%)  0 2/439 (0.46%)  2 0/510 (0.00%)  0 0/223 (0.00%)  0
Cerebral haemorrhage  1  0/438 (0.00%)  0 1/439 (0.23%)  1 0/510 (0.00%)  0 0/223 (0.00%)  0
Cerebrovascular accident  1  0/438 (0.00%)  0 1/439 (0.23%)  1 0/510 (0.00%)  0 0/223 (0.00%)  0
Convulsion  1  0/438 (0.00%)  0 1/439 (0.23%)  1 0/510 (0.00%)  0 0/223 (0.00%)  0
Dizziness  1  0/438 (0.00%)  0 0/439 (0.00%)  0 1/510 (0.20%)  1 0/223 (0.00%)  0
Presyncope  1  0/438 (0.00%)  0 0/439 (0.00%)  0 1/510 (0.20%)  1 0/223 (0.00%)  0
Sciatica  1  1/438 (0.23%)  1 0/439 (0.00%)  0 0/510 (0.00%)  0 0/223 (0.00%)  0
Transient ischaemic attack  1  1/438 (0.23%)  1 0/439 (0.00%)  0 0/510 (0.00%)  0 0/223 (0.00%)  0
Psychiatric disorders         
Alcoholism  1  1/438 (0.23%)  1 0/439 (0.00%)  0 0/510 (0.00%)  0 0/223 (0.00%)  0
Anxiety  1  0/438 (0.00%)  0 1/439 (0.23%)  1 0/510 (0.00%)  0 0/223 (0.00%)  0
Drug dependence  1  0/438 (0.00%)  0 1/439 (0.23%)  1 0/510 (0.00%)  0 0/223 (0.00%)  0
Suicide attempt  1  0/438 (0.00%)  0 1/439 (0.23%)  1 0/510 (0.00%)  0 0/223 (0.00%)  0
Renal and urinary disorders         
Renal failure acute  1  0/438 (0.00%)  0 0/439 (0.00%)  0 0/510 (0.00%)  0 1/223 (0.45%)  1
Respiratory, thoracic and mediastinal disorders         
Chronic obstructive pulmonary disease  1  8/438 (1.83%)  8 9/439 (2.05%)  9 8/510 (1.57%)  8 4/223 (1.79%)  4
Acute respiratory failure  1  2/438 (0.46%)  2 0/439 (0.00%)  0 1/510 (0.20%)  1 2/223 (0.90%)  2
Respiratory failure  1  0/438 (0.00%)  0 1/439 (0.23%)  1 3/510 (0.59%)  3 0/223 (0.00%)  0
Hypoxia  1  0/438 (0.00%)  0 0/439 (0.00%)  0 1/510 (0.20%)  1 0/223 (0.00%)  0
Acute respiratory distress syndrome  1  0/438 (0.00%)  0 1/439 (0.23%)  1 1/510 (0.20%)  1 0/223 (0.00%)  0
Pneumonia aspiration  1  1/438 (0.23%)  1 1/439 (0.23%)  1 0/510 (0.00%)  0 0/223 (0.00%)  0
Pulmonary embolism  1  0/438 (0.00%)  0 1/439 (0.23%)  1 1/510 (0.20%)  1 0/223 (0.00%)  0
Pulmonary mass  1  0/438 (0.00%)  0 1/439 (0.23%)  1 0/510 (0.00%)  0 0/223 (0.00%)  0
Skin and subcutaneous tissue disorders         
Photosensitivity reaction  1  1/438 (0.23%)  1 0/439 (0.00%)  0 0/510 (0.00%)  0 0/223 (0.00%)  0
Surgical and medical procedures         
Cardiac pacemaker insertion  1  0/438 (0.00%)  0 1/439 (0.23%)  1 0/510 (0.00%)  0 0/223 (0.00%)  0
Vascular disorders         
Hypertension  1  1/438 (0.23%)  1 2/439 (0.46%)  2 0/510 (0.00%)  0 0/223 (0.00%)  0
Deep vein thrombosis  1  0/438 (0.00%)  0 0/439 (0.00%)  0 2/510 (0.39%)  2 0/223 (0.00%)  0
Aortic aneurysm  1  1/438 (0.23%)  1 0/439 (0.00%)  0 0/510 (0.00%)  0 0/223 (0.00%)  0
Essential hypertension  1  0/438 (0.00%)  0 1/439 (0.23%)  1 0/510 (0.00%)  0 0/223 (0.00%)  0
Hypotension  1  0/438 (0.00%)  0 0/439 (0.00%)  0 0/510 (0.00%)  0 1/223 (0.45%)  1
Peripheral artery thrombosis  1  1/438 (0.23%)  1 0/439 (0.00%)  0 0/510 (0.00%)  0 0/223 (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 4%
FF MDI (PT005) GP MDI (PT001) GFF MDI (PT003) Placebo MDI
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/438 (4.79%)      12/439 (2.73%)      22/510 (4.31%)      10/223 (4.48%)    
Infections and infestations         
Nasopharyngitis  1  21/438 (4.79%)  21 12/439 (2.73%)  12 22/510 (4.31%)  22 10/223 (4.48%)  13
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
Layout table for Results Point of Contact information
Name/Title: Colin Reisner, MD, FCCP, FAAAAI
Organization: Pearl Therapeutics, Inc
Phone: 973-975-0320
EMail: creisner@pearltherapeutics.com
Layout table for additonal information
Responsible Party: Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01854658     History of Changes
Other Study ID Numbers: PT003007-00
First Submitted: May 13, 2013
First Posted: May 15, 2013
Results First Submitted: May 21, 2016
Results First Posted: March 28, 2017
Last Update Posted: March 28, 2017