Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Extension Study to Evaluate the Safety and Efficacy of PT003, PT001, and PT005 in Subjects With Moderate to Very Severe COPD, With Spiriva® Handihaler® (PINNACLE 3)

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: NCT01970878
Recruitment Status : Completed
First Posted : October 28, 2013
Results First Posted : February 6, 2017
Last Update Posted : March 17, 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 (PT 003)
Drug: GP MDI (PT001)
Drug: FF MDI (PT005)
Drug: Open-label tiotropium bromide inhalation (Spiriva® Handihaler®)
Enrollment 892
Recruitment Details Conducted at 205 sites from November 2013- December 2014. The entire study period was a maximum of 30 weeks.
Pre-assignment Details Study PT003008 was an extension of Studies NCT01854645 and NCT01854658. A proportion of subjects on active treatment were randomly invited to participate. Analysis of Study PT003008 included all subjects enrolled in the lead-in studies to avoid bias. Hence, the number analyzed will be greater than the 892 subjects enrolled into the extension.
Arm/Group Title GFF MDI (PT003) GP MDI (PT001) FF MDI (PT005) Spiriva® Handihaler® (Open-label)
Hide Arm/Group Description GFF MDI 14.4/9.6 mcg GP MDI 14.4 mcg FF MDI 9.6 mcg Open-label tiotropium bromide inhalation powder 18 mcg
Period Title: Overall Study
Started 290 218 [1] 213 171
Completed 253 191 187 147
Not Completed 37 27 26 24
Reason Not Completed
Withdrawal by Subject             11             10             14             7
Lost to Follow-up             1             3             2             4
Administrative Reasons             1             0             0             4
Lack of Efficacy             2             1             2             0
Adverse Event             12             7             4             3
Protocol Specified Criteria             10             4             3             6
Physician Decision             0             1             1             0
No Completion Status             0             1             0             0
[1]
218 subjects were reported in the CSR, 1 had no completion status
Arm/Group Title GFF MDI (PT003) GP MDI (PT001) FF MDI (PT005) Spiriva® Handihaler® (Open-label) Total
Hide Arm/Group Description GFF MDI 14.4/9.6 mcg GP MDI 14.4 mcg FF MDI 9.6 mcg Open-label tiotropium bromide inhalation powder 18 mcg Total of all reporting groups
Overall Number of Baseline Participants 1035 888 884 450 3257
Hide Baseline Analysis Population Description
Baseline population includes all subjects enrolled into active treatment arms for the lead-in Studies PT003006 & PT003007
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1035 participants 888 participants 884 participants 450 participants 3257 participants
62.7  (8.3) 62.8  (8.4) 62.8  (8.1) 62.9  (8.6) 62.8  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1035 participants 888 participants 884 participants 450 participants 3257 participants
Female
473
  45.7%
392
  44.1%
392
  44.3%
182
  40.4%
1439
  44.2%
Male
562
  54.3%
496
  55.9%
492
  55.7%
268
  59.6%
1818
  55.8%
1.Primary Outcome
Title Change From Baseline in Morning -Pre-dose Trough FEV1 Over 52 Weeks
Hide Description Change From Baseline in Morning Pre-Dose Trough FEV1 Over 52 Weeks as a Model-Based Average (ITT Population). FEV1 was assessed at multiple time points post-baseline, and a model-based average of all visits starting from Week 2 through week 52 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average FEV1 post-baseline.
Time Frame Baseline and Weeks 2 to 52
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in the ITT population from the lead-in studies who had data for the parameter.
Arm/Group Title GFF MDI (PT003) GP MDI (PT001) FF MDI (PT005) Spiriva® Handihaler® (Open-label)
Hide Arm/Group Description:
GFF MDI 14.4/9.6 mcg
GP MDI 14.4 mcg
FF MDI 9.6 mcg
Open-label tiotropium bromide inhalation powder 18 mcg
Overall Number of Participants Analyzed 1021 872 871 445
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters
0.133
(0.122 to 0.144)
0.076
(0.064 to 0.088)
0.068
(0.056 to 0.080)
0.107
(0.091 to 0.124)
2.Secondary Outcome
Title Self-Administered Computerized (SAC) TDI Focal Score Over 52 Weeks
Hide Description SAC TDI focal score over 52 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9.
Time Frame Baseline and Weeks 4 to 52
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in the ITT population from the lead-in studies who had data for the parameter.
Arm/Group Title GFF MDI (PT003) GP MDI (PT001) FF MDI (PT005) Spiriva® Handihaler® (Open-label)
Hide Arm/Group Description:
GFF MDI 14.4/9.6 mcg
GP MDI 14.4 mcg
FF MDI 9.6 mcg
Open-label tiotropium bromide inhalation powder 18 mcg
Overall Number of Participants Analyzed 1002 867 871 442
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
0.5
(0.4 to 0.6)
0.3
(0.2 to 0.4)
0.3
(0.2 to 0.4)
0.4
(0.3 to 0.6)
3.Secondary Outcome
Title Peak Change From Baseline in FEV1 Within 2 Hrs Post-dosing
Hide Description Peak change from Baseline FEV1 Over 52 Weeks is a Model-Based Average (ITT Population). Peak FEV1 was assessed at multiple visits post-baseline, and a model-based average of all visits starting from Week 2 through week 52 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average Peak FEV1 post-baseline.
Time Frame Baseline and Weeks 2 to 52
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in the ITT population from the lead-in studies who had data for the parameter.
Arm/Group Title GFF MDI (PT003) GP MDI (PT001) FF MDI (PT005) Spiriva® Handihaler® (Open-label)
Hide Arm/Group Description:
GFF MDI 14.4/9.6 mcg
GP MDI 14.4 mcg
FF MDI 9.6 mcg
Open-label tiotropium bromide inhalation powder 18 mcg
Overall Number of Participants Analyzed 1035 888 883 450
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters
0.363
(0.351 to 0.375)
0.234
(0.221 to 0.247)
0.275
(0.262 to 0.288)
0.270
(0.251 to 0.288)
4.Secondary Outcome
Title Change From Baseline in SGRQ Total Score
Hide Description 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 (best possible health status) to 100 (worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life. SGRQ Total Score was assessed at multiple visits post-baseline, and a model-based average of all visits starting from Week 12 through week 52 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average SGRQ Total Score post-baseline.
Time Frame Baseline and Weeks 12 to 52
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in the ITT population from the lead-in studies who had data for the parameter
Arm/Group Title GFF MDI (PT003) GP MDI (PT001) FF MDI (PT005) Spiriva® Handihaler® (Open-label)
Hide Arm/Group Description:
GFF MDI 14.4/9.6 mcg
GP MDI 14.4 mcg
FF MDI 9.6 mcg
Open-label tiotropium bromide inhalation powder 18 mcg
Overall Number of Participants Analyzed 995 843 845 434
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
-3.3
(-4.0 to -2.6)
-1.9
(-2.7 to -1.2)
-2.4
(-3.2 to -1.7)
-2.9
(-4.0 to -1.8)
5.Secondary Outcome
Title Change From Baseline in Average Daily Rescue Ventolin Use
Hide Description Subjects recorded in their diary the number of puffs of rescue Ventolin HFA taken on each study day. The subject’s average daily number of puffs of rescue Ventolin HFA was calculated over the entire 52-week treatment period. Missing values were ignored in both the numerator and denominator. Diary data recorded during the last 7 days of the 10-14 day screening period were used to calculate the baseline average. Change in rescue Ventolin HFA use was calculated by subtracting the baseline average from the 52-week average.
Time Frame Baseline through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in the ITT population from the lead-in studies who had data for the parameter
Arm/Group Title GFF MDI (PT003) GP MDI (PT001) FF MDI (PT005) Spiriva® Handihaler® (Open-label)
Hide Arm/Group Description:
GFF MDI 14.4/9.6 mcg
GP MDI 14.4 mcg
FF MDI 9.6 mcg
Open-label tiotropium bromide inhalation powder 18 mcg
Overall Number of Participants Analyzed 1035 885 881 447
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Puffs per day
-0.9
(-1.0 to -0.7)
-0.4
(-0.6 to -0.3)
-0.7
(-0.8 to -0.5)
-0.4
(-0.6 to -0.1)
Time Frame 52 Weeks
Adverse Event Reporting Description The Safety Population was similar to the ITT Population (all subjects who were randomized to active [non-placebo] treatment in Study PT003006 or Study PT003007 and received at least 1 dose of the study treatment in Study PT003006 or Study PT003007, regardless of whether or not they participated in Study PT003008).
 
Arm/Group Title GFF MDI (PT003) GP MDI (PT001) FF MDI (PT005) Spiriva® Handihaler® (Open-label)
Hide Arm/Group Description GFF MDI 14.4/9.6 mcg GP MDI 14.4 mcg FF MDI 9.6 mcg Open-label tiotropium bromide inhalation powder 18 mcg
All-Cause Mortality
GFF MDI (PT003) GP MDI (PT001) FF MDI (PT005) Spiriva® Handihaler® (Open-label)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
GFF MDI (PT003) GP MDI (PT001) FF MDI (PT005) Spiriva® Handihaler® (Open-label)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   114/1036 (11.00%)      90/890 (10.11%)      78/890 (8.76%)      49/451 (10.86%)    
Blood and lymphatic system disorders         
Anaemia  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 1/451 (0.22%)  1
Cardiac disorders         
Atrial Fibrillation  1  4/1036 (0.39%)  4 2/890 (0.22%)  3 1/890 (0.11%)  1 0/451 (0.00%)  0
Cardiac failure congestive  1  2/1036 (0.19%)  2 2/890 (0.22%)  2 0/890 (0.00%)  0 2/451 (0.44%)  4
Acute myocardial infrarction  1  3/1036 (0.29%)  3 2/890 (0.22%)  2 1/890 (0.11%)  1 0/451 (0.00%)  0
Myocardial infarction  1  2/1036 (0.19%)  2 1/890 (0.11%)  1 0/890 (0.00%)  0 1/451 (0.22%)  1
Coronary artery disease  1  1/1036 (0.10%)  1 1/890 (0.11%)  1 0/890 (0.00%)  0 1/451 (0.22%)  1
Atrial Flutter  1  0/1036 (0.00%)  0 2/890 (0.22%)  2 0/890 (0.00%)  0 0/451 (0.00%)  0
Bradycardia  1  0/1036 (0.00%)  0 2/890 (0.22%)  2 0/890 (0.00%)  0 0/451 (0.00%)  0
Cardiac arrest  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 1/890 (0.11%)  1 0/451 (0.00%)  0
Angina pectoris  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Atrial tachycardia  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Atriventricular block  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 1/890 (0.11%)  1 0/451 (0.00%)  0
Atrioventricular block second degree  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 0/890 (0.00%)  0 0/451 (0.00%)  0
Cardiac failure acute  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Cardio-respiratory arrest  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Cardiogenic shock  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Cardio myopathy  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 0/890 (0.00%)  0 1/451 (0.22%)  1
Coronary artery occulsion  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 0/890 (0.00%)  0 0/451 (0.00%)  0
Coronary artery stenosis  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Ischemic cardiomyopathy  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Myocardial iscaemia  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Ventricular fibrillation  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 1/890 (0.11%)  1 0/451 (0.00%)  0
Ear and labyrinth disorders         
Vertigo  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 1/890 (0.11%)  1 0/451 (0.00%)  0
Endocrine disorders         
Hyperparathyroidism  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 0/890 (0.00%)  0 1/451 (0.22%)  1
Gastrointestinal disorders         
Intestinal Obstruction  1  1/1036 (0.10%)  1 2/890 (0.22%)  2 0/890 (0.00%)  0 1/451 (0.22%)  1
Small intestinal obstruction  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 2/890 (0.22%)  2 1/451 (0.22%)  1
Abdominal pain  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 2/890 (0.22%)  2 0/451 (0.00%)  0
Pancreatitis  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 2/451 (0.44%)  2
Upper gastrointestinal haemmorrhage  1  0/1036 (0.00%)  0 2/890 (0.22%)  2 1/890 (0.11%)  1 0/451 (0.00%)  0
Abdominal hernia  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Abdominal mass  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 0/890 (0.00%)  0 0/451 (0.00%)  0
Abdominal pain lower  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Abdominal pain upper  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Constipation  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Enteritis  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 0/890 (0.00%)  0 0/451 (0.00%)  0
Gastritis  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 0/890 (0.00%)  0 0/451 (0.00%)  0
Gastrointestial haemorrhage  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 1/890 (0.11%)  1 0/451 (0.00%)  0
Ileus  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 1/890 (0.11%)  1 0/451 (0.00%)  0
Large Intestine polyp  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Nausea  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Oesophageal ulcer  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 1/890 (0.11%)  1 0/451 (0.00%)  0
Pancreatic mass  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Pancreatitis acute  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Pancreatitis chronic  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 1/890 (0.11%)  1 0/451 (0.00%)  0
Retroperitoneal haemorrhage  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 1/890 (0.11%)  1 0/451 (0.00%)  0
General disorders         
Chest pain  1  4/1036 (0.39%)  4 3/890 (0.34%)  3 4/890 (0.45%)  4 1/451 (0.22%)  1
Non-cardiac chest pain  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 3/890 (0.34%)  3 0/451 (0.00%)  0
Chest discomfort  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Death  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Device occlusion  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Inflammation  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 0/890 (0.00%)  0 1/451 (0.22%)  1
Pyrexia  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Sudden cardiac death  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 0/890 (0.00%)  0 1/451 (0.22%)  1
Hepatobiliary disorders         
Cholecystitis acute  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 1/890 (0.11%)  1 1/451 (0.22%)  1
Cholecystitis  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 0/890 (0.00%)  0 1/451 (0.22%)  1
Cholelithiasis  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Hepatic steatosis  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 0/890 (0.00%)  0 0/451 (0.00%)  0
Infections and infestations         
Pneumonia  1  15/1036 (1.45%)  15 14/890 (1.57%)  14 4/890 (0.45%)  4 1/451 (0.22%)  1
Sepsis  1  0/1036 (0.00%)  0 3/890 (0.34%)  3 0/890 (0.00%)  0 1/451 (0.22%)  1
Cellulitis  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 2/451 (0.44%)  2
Diverticulitis  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 2/890 (0.22%)  2 0/451 (0.00%)  0
Lobar Pneumonia  1  2/1036 (0.19%)  2 0/890 (0.00%)  0 1/890 (0.11%)  1 0/451 (0.00%)  0
Influenza  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 1/890 (0.11%)  1 0/451 (0.00%)  0
Staphylococcal Infection  1  0/1036 (0.00%)  0 2/890 (0.22%)  2 0/890 (0.00%)  0 0/451 (0.00%)  0
Urinary Tract Infection  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 1/890 (0.11%)  1 0/451 (0.00%)  0
Bronchitis  1  0/1036 (0.00%)  0 1/890 (0.11%)  2 0/890 (0.00%)  0 0/451 (0.00%)  0
Appendicitis  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 0/890 (0.00%)  0 1/451 (0.22%)  1
Atypical Pneuomonia  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 0/890 (0.00%)  0 1/451 (0.22%)  1
Cellulitis Staphylococcal  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 0/890 (0.00%)  0 0/451 (0.00%)  0
Extradural Abscess  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 1/890 (0.11%)  1 0/451 (0.00%)  0
Localised Infection  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Opthalmic herpes zoster  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 1/890 (0.11%)  1 0/451 (0.00%)  0
Pneumonia bacterial  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 0/890 (0.00%)  0 0/451 (0.00%)  0
Pneumonia necrotising  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Pneumonia pneumococcal  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 1/890 (0.11%)  1 0/451 (0.00%)  0
Post procedural sepsis  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 0/890 (0.00%)  0 0/451 (0.00%)  0
Post Operative wound infection  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 0/890 (0.00%)  0 0/451 (0.00%)  0
Pyelonephritis  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Rhinovirus infection  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 0/890 (0.00%)  0 0/451 (0.00%)  0
Septic Shock  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Urospepsis  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Injury, poisoning and procedural complications         
Fibula fracture  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 1/890 (0.11%)  1 1/451 (0.22%)  1
Alcohol poisoning  1  0/1036 (0.00%)  0 2/890 (0.22%)  2 0/890 (0.00%)  0 0/451 (0.00%)  0
Fall  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 1/890 (0.11%)  1 1/451 (0.22%)  1
Rib fracture  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 1/890 (0.11%)  1 0/451 (0.00%)  0
Ankle fracture  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 0/890 (0.00%)  0 0/451 (0.00%)  0
Cervical vertebral fracture  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 0/890 (0.00%)  0 1/451 (0.22%)  1
Femoral neck fracture  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 0/890 (0.00%)  0 0/451 (0.00%)  0
Gun shot wound  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Hip fracture  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Humerus fracture  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Overdose  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 0/890 (0.00%)  0 1/451 (0.22%)  1
Patella fracture  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 0/890 (0.00%)  0 0/451 (0.00%)  0
Pneumothorax traumatic  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 1/890 (0.11%)  1 0/451 (0.00%)  0
Radius fracture  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 1/890 (0.11%)  1 0/451 (0.00%)  0
Splenic rupture  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 0/890 (0.00%)  0 0/451 (0.00%)  0
Subdural haematoma  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 1/890 (0.11%)  1 0/451 (0.00%)  0
Tendon rupture  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Thermal burn  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 0/890 (0.00%)  0 1/451 (0.22%)  1
Investigations         
Electrocardiogram QT prolonged  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 0/890 (0.00%)  0 0/451 (0.00%)  0
Metabolism and nutrition disorders         
Diabetes mellitus  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Diabetic ketoacidosis  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 0/890 (0.00%)  0 1/451 (0.22%)  1
Gout  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Hyperglycaemia  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Hypoglycaemia  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 0/890 (0.00%)  0 0/451 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Intervertebral disc degeneration  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Intervertebral disc displacement  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 0/890 (0.00%)  0 0/451 (0.00%)  0
Lumbar spinal stenosis  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Osteoarthritis  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Spinal column stenosis  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Spinal pain  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 0/890 (0.00%)  0 1/451 (0.22%)  1
Vertebral foraminal stenosis  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 1/890 (0.11%)  1 0/451 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Squamous cell carcinoma of lung  1  2/1036 (0.19%)  2 0/890 (0.00%)  0 0/890 (0.00%)  0 3/451 (0.67%)  3
Lung adenocarcinoma  1  1/1036 (0.10%)  1 1/890 (0.11%)  1 2/890 (0.22%)  2 0/451 (0.00%)  0
Lung Neoplasm Malignant  1  2/1036 (0.19%)  2 0/890 (0.00%)  0 2/890 (0.22%)  2 0/451 (0.00%)  0
Breast Cancer  1  2/1036 (0.19%)  2 0/890 (0.00%)  0 0/890 (0.00%)  0 1/451 (0.22%)  1
Prostate Cancer  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 2/890 (0.22%)  2 0/451 (0.00%)  0
Squamous cell carcinoma of skin  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 1/451 (0.22%)  1
Transitional cell carcinoma  1  0/1036 (0.00%)  0 2/890 (0.22%)  2 0/890 (0.00%)  0 0/451 (0.00%)  0
Basal Cell Carcinoma  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Bladder Cancer  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Bladder Neoplasm  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 0/890 (0.00%)  0 0/451 (0.00%)  0
Epiglottic carcinoma  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Hepatic Cancer  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Hepatocelluar carcinoma  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Laryngeal cancer  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 0/890 (0.00%)  0 1/451 (0.22%)  1
Laryngeal cancer stage 0  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 1/890 (0.11%)  1 0/451 (0.00%)  0
Malignant melanoma  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 0/890 (0.00%)  0 0/451 (0.00%)  0
Metastatic neoplasm  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Non-small cell lung cancer  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 1/890 (0.11%)  1 0/451 (0.00%)  0
Oesophageal adenocarcinoma  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Oropharyngeal squamous cell carcinoma  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 0/890 (0.00%)  0 0/451 (0.00%)  0
Pancreatic carcinoma  2  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Rectal adenocarcinoma  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 1/890 (0.11%)  1 0/451 (0.00%)  0
Small cell lung cancer  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Small cell lung cancer metastatic  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 0/890 (0.00%)  0 1/451 (0.22%)  1
Squamous cell carcinoma of the oral cavity  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 0/890 (0.00%)  0 1/451 (0.22%)  1
Uterine leiomyoma  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 0/890 (0.00%)  0 0/451 (0.00%)  0
Nervous system disorders         
Syncope  1  0/1036 (0.00%)  0 3/890 (0.34%)  3 1/890 (0.11%)  1 0/451 (0.00%)  0
Transient ischaemic attack  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 2/890 (0.22%)  2 1/451 (0.22%)  1
Cerebrovascular accident  1  1/1036 (0.10%)  1 1/890 (0.11%)  1 0/890 (0.00%)  0 0/451 (0.00%)  0
Cerebral haemorrhage  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 0/890 (0.00%)  0 0/451 (0.00%)  0
Convulsion  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 0/890 (0.00%)  0 0/451 (0.00%)  0
Dizziness  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Encephalopathy  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Generalised tonic-clonic seizure  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 0/890 (0.00%)  0 1/451 (0.22%)  1
Presyncope  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Sciatica  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 1/890 (0.11%)  1 0/451 (0.00%)  0
Psychiatric disorders         
Anxiety  1  0/1036 (0.00%)  0 2/890 (0.22%)  2 0/890 (0.00%)  0 0/451 (0.00%)  0
Suicide attempt  1  0/1036 (0.00%)  0 2/890 (0.22%)  2 0/890 (0.00%)  0 0/451 (0.00%)  0
Alcoholism  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 1/890 (0.11%)  1 0/451 (0.00%)  0
Completed suicide  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 0/890 (0.00%)  0 1/451 (0.22%)  1
Depression  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 0/890 (0.00%)  0 0/451 (0.00%)  0
Drug dependence  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 0/890 (0.00%)  0 0/451 (0.00%)  0
Homicidal ideation  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 0/890 (0.00%)  0 1/451 (0.22%)  1
Intentional self-injury  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 0/890 (0.00%)  0 1/451 (0.22%)  1
Renal and urinary disorders         
Bladder cyst  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Bladder mass  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 0/890 (0.00%)  0 0/451 (0.00%)  0
Nephrolithiasis  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 0/890 (0.00%)  0 0/451 (0.00%)  0
Renal failure acute  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 1/890 (0.11%)  1 0/451 (0.00%)  0
Urethral stenosis  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Reproductive system and breast disorders         
Epididymal cyst  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 1/890 (0.11%)  1 0/451 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Chronic Obstructive Pulmonary Disease  1  32/1036 (3.09%)  32 30/890 (3.37%)  33 19/890 (2.13%)  19 12/451 (2.66%)  12
Acute Respiratory Failure  1  2/1036 (0.19%)  2 2/890 (0.22%)  2 4/890 (0.45%)  4 0/451 (0.00%)  0
Respiratory Failure  1  4/1036 (0.39%)  4 2/890 (0.22%)  2 0/890 (0.00%)  0 0/451 (0.00%)  0
Acute Respiratory Distress Syndrome  1  1/1036 (0.10%)  1 2/890 (0.22%)  2 0/890 (0.00%)  0 0/451 (0.00%)  0
Pulmonary Embolism  1  2/1036 (0.19%)  2 1/890 (0.11%)  1 0/890 (0.00%)  0 0/451 (0.00%)  0
Pneumonia Aspiration  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 1/890 (0.11%)  1 0/451 (0.00%)  0
Bronchospasm  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 1/890 (0.11%)  1 0/451 (0.00%)  0
Hypoxia  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Pleurisy  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 1/890 (0.11%)  1 0/451 (0.00%)  0
Pulmonary Mass  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 0/890 (0.00%)  0 0/451 (0.00%)  0
Pulmonary oedema  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 1/890 (0.11%)  1 0/451 (0.00%)  0
Skin and subcutaneous tissue disorders         
Photosensitivity reaction  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 1/890 (0.11%)  1 0/451 (0.00%)  0
Surgical and medical procedures         
Cardiac pacemaker insertion  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 0/890 (0.00%)  0 0/451 (0.00%)  0
Vascular disorders         
Aortic aneurysm  1  1/1036 (0.10%)  2 0/890 (0.00%)  0 3/890 (0.34%)  3 0/451 (0.00%)  0
Deep vein thrombosis  1  2/1036 (0.19%)  2 0/890 (0.00%)  0 1/890 (0.11%)  1 1/451 (0.22%)  1
Hypertension  1  0/1036 (0.00%)  0 2/890 (0.22%)  2 1/890 (0.11%)  1 0/451 (0.00%)  0
Peripheral artery stenosis  1  2/1036 (0.19%)  2 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Peripheral vascular disorder  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 1/890 (0.11%)  1 0/451 (0.00%)  0
Aortic dissection  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 0/890 (0.00%)  0 0/451 (0.00%)  0
Essential hypertension  1  0/1036 (0.00%)  0 1/890 (0.11%)  1 0/890 (0.00%)  0 0/451 (0.00%)  0
Femoral artery occlusion  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Hypertensive crisis  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 1/890 (0.11%)  1 0/451 (0.00%)  0
Hypertensive emergency  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Hypotension  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 1/890 (0.11%)  1 0/451 (0.00%)  0
Malignant hypertension  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Peripheral artery thrombosis  1  0/1036 (0.00%)  0 0/890 (0.00%)  0 1/890 (0.11%)  1 0/451 (0.00%)  0
Thrombophlebitis superficial  1  1/1036 (0.10%)  1 0/890 (0.00%)  0 0/890 (0.00%)  0 0/451 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
2
Term from vocabulary, MeDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GFF MDI (PT003) GP MDI (PT001) FF MDI (PT005) Spiriva® Handihaler® (Open-label)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   109/1036 (10.52%)      77/890 (8.65%)      90/890 (10.11%)      51/451 (11.31%)    
Infections and infestations         
Nasopharyngitis  1  70/1036 (6.76%)  74 38/890 (4.27%)  40 55/890 (6.18%)  61 28/451 (6.21%)  28
Upper Respiratory Tract Infection  1  39/1036 (3.76%)  42 39/890 (4.38%)  44 35/890 (3.93%)  38 23/451 (5.10%)  24
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: NCT01970878     History of Changes
Other Study ID Numbers: PT003008-00
First Submitted: October 18, 2013
First Posted: October 28, 2013
Results First Submitted: May 21, 2016
Results First Posted: February 6, 2017
Last Update Posted: March 17, 2017