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A Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Period in Subjects With Moderate to Very Severe COPD (Sophos)

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ClinicalTrials.gov Identifier: NCT02727660
Recruitment Status : Completed
First Posted : April 4, 2016
Results First Posted : September 26, 2019
Last Update Posted : September 26, 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 (PT009) 320/9.6 μg
Drug: BFF MDI (PT009) 160/9.6 μg
Drug: FF MDI (PT005) 9.6 μg
Enrollment 1876
Recruitment Details This study screened subjects at 292 study centers in 18 countries and randomized subjects at 259 study centers, from April 2016 to April 2018.
Pre-assignment Details Subjects were randomized in a 1:1:1 ratio to BFF MDI 320/9.6 μg, BFF MDI 160/9.6 μg, and FF MDI 9.6 μg treatment groups
Arm/Group Title BFF MDI 320/9.6 ug BFF MDI 160/9.6 ug FF MDI 9.6 ug
Hide Arm/Group Description Budesonide Formoterol Fumarate Metered dose inhalation 320/9.6 ug Budesonide Formoterol Fumarate Metered dose inhalation 160/9.6 ug Formoterol Fumarate Metered dose inhalation 9.6 ug
Period Title: Overall Study
Started [1] 619 617 607
Completed [2] 503 501 442
Not Completed 116 116 165
Reason Not Completed
Lack of Efficacy             40             40             70
Adverse Event             28             21             32
Withdrawal by Subject             26             25             30
Physician Decision             3             8             14
Lost to Follow-up             5             9             8
Protocol Violation             7             5             5
Protocol Specified Disc. Criteria             5             5             2
Administrative Reasons             2             3             4
[1]
mITT Population
[2]
Completed Study Treatment
Arm/Group Title BFF MDI 320/9.6 ug BFF MDI 160/9.6 ug FF MDI 9.6 ug Total
Hide Arm/Group Description Budesonide Formoterol Fumarate Metered dose inhalation 320/9.6 ug Budesonide Formoterol Fumarate Metered dose inhalation 160/9.6 ug Formoterol Fumarate Metered dose inhalation 9.6 ug Total of all reporting groups
Overall Number of Baseline Participants 629 630 617 1876
Hide Baseline Analysis Population Description
The Intent-To-Treat (ITT) Population is defined as all subjects who were randomized to treatment (presented here). The Modified Intent-To-Treat (mITT) Population, a subset of the ITT Population, is defined as all subjects with post-randomization data obtained prior to d/c from treatment. The mITT Population was used for all efficacy analyses.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 619 participants 617 participants 607 participants 1843 participants
65.3  (8.1) 64.5  (8.4) 64.8  (8.5) 64.9  (8.3)
[1]
Measure Analysis Population Description: mITT Population
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 619 participants 617 participants 607 participants 1843 participants
Female
252
  40.7%
272
  44.1%
268
  44.2%
792
  43.0%
Male
367
  59.3%
345
  55.9%
339
  55.8%
1051
  57.0%
[1]
Measure Analysis Population Description: mITT Population
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 619 participants 617 participants 607 participants 1843 participants
Hispanic or Latino
190
  30.7%
200
  32.4%
190
  31.3%
580
  31.5%
Not Hispanic or Latino
423
  68.3%
414
  67.1%
412
  67.9%
1249
  67.8%
Unknown or Not Reported
6
   1.0%
3
   0.5%
5
   0.8%
14
   0.8%
[1]
Measure Analysis Population Description: mITT Population
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 619 participants 617 participants 607 participants 1843 participants
American Indian or Alaska Native
26
   4.2%
18
   2.9%
24
   4.0%
68
   3.7%
Asian
1
   0.2%
7
   1.1%
4
   0.7%
12
   0.7%
Native Hawaiian or Other Pacific Islander
1
   0.2%
0
   0.0%
0
   0.0%
1
   0.1%
Black or African American
30
   4.8%
22
   3.6%
29
   4.8%
81
   4.4%
White
514
  83.0%
516
  83.6%
504
  83.0%
1534
  83.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
47
   7.6%
54
   8.8%
46
   7.6%
147
   8.0%
[1]
Measure Analysis Population Description: mITT Population
1.Primary Outcome
Title Morning Pre-dose Trough FEV1
Hide Description Morning pre-dose trough FEV1 (Forced Expiratory Volume in one second) at week 12
Time Frame at Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population Only subjects who had morning pre-dose trough FEV1 measured at the week 12 visit are included in the “at Week 12” timepoint
Arm/Group Title BFF MDI 320/9.6 ug BFF MDI 160/9.6 ug FF MDI 9.6 ug
Hide Arm/Group Description:
Budesonide Formoterol Fumarate Metered dose inhalation 320/9.6 ug
Budesonide Formoterol Fumarate Metered dose inhalation 160/9.6 ug
Formoterol Fumarate Metered dose inhalation 9.6 ug
Overall Number of Participants Analyzed 542 540 501
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liter
0.072
(0.053 to 0.090)
0.069
(0.051 to 0.087)
0.037
(0.018 to 0.056)
2.Secondary Outcome
Title Time to First Moderate or Severe COPD Exacerbation
Hide Description Time to first moderate or severe COPD (Chronic Obstructive Pulmonary Disease) exacerbation over 52 weeks
Time Frame over 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title BFF MDI 320/9.6 ug BFF MDI 160/9.6 ug FF MDI 9.6 ug
Hide Arm/Group Description:
Budesonide Formoterol Fumarate Metered dose inhalation 320/9.6 ug
Budesonide Formoterol Fumarate Metered dose inhalation 160/9.6 ug
Formoterol Fumarate Metered dose inhalation 9.6 ug
Overall Number of Participants Analyzed 619 617 607
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Subjects with Exacerbation
Percent of Subjects Exacerbated within 12 Weeks
19.2
(16.2 to 22.6)
19.3
(16.3 to 22.7)
24.8
(21.5 to 28.6)
Percent of Subjects Exacerbated within 24 Weeks
31.2
(27.5 to 35.4)
32.9
(29.1 to 37.1)
35.1
(31.3 to 39.4)
Percent of Subjects Exacerbated within 36 Weeks
41.0
(36.5 to 45.9)
41.3
(36.9 to 46.0)
46.2
(41.5 to 51.2)
Percent of Subjects Exacerbated within 52 Weeks
50.1
(44.4 to 56.0)
48.6
(43.1 to 54.4)
54.8
(49.0 to 60.7)
3.Secondary Outcome
Title Change From Baseline in Average Daily Rescue Ventolin HFA Use
Hide Description Change from baseline in average daily rescue Ventolin HFA use over 12 weeks
Time Frame over 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population Only subjects who had rescue Ventolin HFA doses recorded over the 12 week period are included in the “over 12 Weeks” timepoint
Arm/Group Title BFF MDI 320/9.6 ug BFF MDI 160/9.6 ug FF MDI 9.6 ug
Hide Arm/Group Description:
Budesonide Formoterol Fumarate Metered dose inhalation 320/9.6 ug
Budesonide Formoterol Fumarate Metered dose inhalation 160/9.6 ug
Formoterol Fumarate Metered dose inhalation 9.6 ug
Overall Number of Participants Analyzed 612 610 599
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Puffs per day
-0.9
(-1.1 to -0.7)
-0.9
(-1.1 to -0.7)
-0.6
(-0.8 to -0.4)
4.Secondary Outcome
Title Percentage of Subjects Achieving an MCID (Minimal Clinically Important Difference) of 4 Units or More in Saint George’s Respiratory Questionnaire (SGRQ) Total Score
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 on health-related quality of life as compared to FF MDI 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. A decrease from baseline in SGRQ total score of 4 units or more is considered a clinically meaningful improvement in quality of life.
Time Frame at Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title BFF MDI 320/9.6 ug BFF MDI 160/9.6 ug FF MDI 9.6 ug
Hide Arm/Group Description:
Budesonide Formoterol Fumarate Metered dose inhalation 320/9.6 ug
Budesonide Formoterol Fumarate Metered dose inhalation 160/9.6 ug
Formoterol Fumarate Metered dose inhalation 9.6 ug
Overall Number of Participants Analyzed 619 617 607
Measure Type: Number
Unit of Measure: Percentage of Subjects
52 54 44
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 52 weeks, which includes screening and follow up (14 days after last dose of study drug).
 
Arm/Group Title BFF MDI 320/9.6 ug BFF MDI 160/9.6 ug FF MDI 9.6 ug
Hide Arm/Group Description Budesonide Formoterol Fumarate Metered dose inhalation 320/9.6 ug Budesonide Formoterol Fumarate Metered dose inhalation 160/9.6 ug Formoterol Fumarate Metered dose inhalation 9.6 ug
All-Cause Mortality
BFF MDI 320/9.6 ug BFF MDI 160/9.6 ug FF MDI 9.6 ug
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/619 (0.48%)      4/617 (0.65%)      8/607 (1.32%)    
Show Serious Adverse Events Hide Serious Adverse Events
BFF MDI 320/9.6 ug BFF MDI 160/9.6 ug FF MDI 9.6 ug
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   60/619 (9.69%)      78/617 (12.64%)      83/607 (13.67%)    
Cardiac disorders       
Acute myocardial infarction  1  0/619 (0.00%)  0 0/617 (0.00%)  0 4/607 (0.66%)  4
Cardiac failure congestive  1  1/619 (0.16%)  1 2/617 (0.32%)  2 1/607 (0.16%)  1
Atrial fibrilation  1  0/619 (0.00%)  0 3/617 (0.49%)  3 0/607 (0.00%)  0
Myocardial infarction  1  0/619 (0.00%)  0 2/617 (0.32%)  2 1/607 (0.16%)  1
Cardiac arrest  1  0/619 (0.00%)  0 0/617 (0.00%)  0 2/607 (0.33%)  2
Cardiac failure  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  2
Angina unstable  1  0/619 (0.00%)  0 1/617 (0.16%)  1 0/607 (0.00%)  0
Atrial flutter  1  0/619 (0.00%)  0 1/617 (0.16%)  1 0/607 (0.00%)  0
Bradycardia  1  1/619 (0.16%)  1 0/617 (0.00%)  0 0/607 (0.00%)  0
Cardiac failure acute  1  0/619 (0.00%)  0 1/617 (0.16%)  1 0/607 (0.00%)  0
Cardio-respiratory arrest  1  1/619 (0.16%)  1 0/617 (0.00%)  0 0/607 (0.00%)  0
Cor pulmonae  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  1
Left ventricular failure  1  0/619 (0.00%)  0 1/617 (0.16%)  1 0/607 (0.00%)  0
Ventricular tachycardia  1  1/619 (0.16%)  1 0/617 (0.00%)  0 0/607 (0.00%)  0
Eye disorders       
Diplopia  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  1
Gastrointestinal disorders       
Small intestinal obstruction  1  1/619 (0.16%)  1 2/617 (0.32%)  2 2/607 (0.33%)  2
Abdominal pain  1  0/619 (0.00%)  0 2/617 (0.32%)  2 2/607 (0.33%)  2
Inguinal hernia  1  0/619 (0.00%)  0 3/617 (0.49%)  3 0/607 (0.00%)  0
Pancreatitis acute  1  1/619 (0.16%)  1 0/617 (0.00%)  0 1/607 (0.16%)  1
Abdominal hernia  1  0/619 (0.00%)  0 1/617 (0.16%)  1 0/607 (0.00%)  0
Abdominal pain upper  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  1
Colitis  1  1/619 (0.16%)  1 0/617 (0.00%)  0 0/607 (0.00%)  0
Gastritis  1  0/619 (0.00%)  0 1/617 (0.16%)  1 0/607 (0.00%)  0
Oesophageal obstruction  1  0/619 (0.00%)  0 1/617 (0.16%)  1 0/607 (0.00%)  0
Pancreatitis  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  1
Peptic ulcer  1  1/619 (0.16%)  1 0/617 (0.00%)  0 0/607 (0.00%)  0
General disorders       
Chest pain  1  0/619 (0.00%)  0 2/617 (0.32%)  2 0/607 (0.00%)  0
Non-cardiac chest pain  1  2/619 (0.32%)  2 0/617 (0.00%)  0 0/607 (0.00%)  0
Asthenia  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  1
Death  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  1
Multiple organ dysfunction syndrome  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  1
Sudden death  1  0/619 (0.00%)  0 1/617 (0.16%)  1 0/607 (0.00%)  0
Hepatobiliary disorders       
Cholangitis  1  0/619 (0.00%)  0 1/617 (0.16%)  1 0/607 (0.00%)  0
Cholecystitis acute  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  1
Cholelithiasis  1  0/619 (0.00%)  0 1/617 (0.16%)  1 0/607 (0.00%)  0
Infections and infestations       
Pneumonia  1  6/619 (0.97%)  6 12/617 (1.94%)  12 9/607 (1.48%)  9
Bronchitis  1  1/619 (0.16%)  1 1/617 (0.16%)  1 1/607 (0.16%)  1
Influenza  1  0/619 (0.00%)  0 2/617 (0.32%)  2 1/607 (0.16%)  1
Sepsis  1  1/619 (0.16%)  1 0/617 (0.00%)  0 2/607 (0.33%)  2
Urinary tract infection  1  0/619 (0.00%)  0 2/617 (0.32%)  4 0/607 (0.00%)  0
Gastroenteritis  1  1/619 (0.16%)  1 0/617 (0.00%)  0 1/607 (0.16%)  1
Diverticulitis  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  2
Abscess intestinal  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  1
Appendicitis perforated  1  1/619 (0.16%)  1 0/617 (0.00%)  0 0/607 (0.00%)  0
Clostridial infection  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  1
Clostridium difficile colitis  1  1/619 (0.16%)  1 0/617 (0.00%)  0 0/607 (0.00%)  0
Clostridium difficile infection  1  0/619 (0.00%)  0 1/617 (0.16%)  1 0/607 (0.00%)  0
Hydrocele male infected  1  0/619 (0.00%)  0 1/617 (0.16%)  1 0/607 (0.00%)  0
Osteomyelitis  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  1
Pneumonia bacterial  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  1
Pnuemonia mycoplasmal  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  1
Pneumonia streptococcal  1  1/619 (0.16%)  1 0/617 (0.00%)  0 0/607 (0.00%)  0
Post procedural infection  1  1/619 (0.16%)  1 0/617 (0.00%)  0 0/607 (0.00%)  0
Pyelonephritis  1  1/619 (0.16%)  1 0/617 (0.00%)  0 0/607 (0.00%)  0
Septic shock  1  0/619 (0.00%)  0 1/617 (0.16%)  1 0/607 (0.00%)  0
Erysipelas  1  1/619 (0.16%)  1 0/617 (0.00%)  0 0/607 (0.00%)  0
Injury, poisoning and procedural complications       
Hip fracture  1  1/619 (0.16%)  1 1/617 (0.16%)  1 0/607 (0.00%)  0
Abdominal injury  1  1/619 (0.16%)  1 0/617 (0.00%)  0 0/607 (0.00%)  0
Ankle fracture  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  1
Craniocerebral injury  1  0/619 (0.00%)  0 1/617 (0.16%)  1 0/607 (0.00%)  0
Fall  1  1/619 (0.16%)  1 0/617 (0.00%)  0 0/607 (0.00%)  0
Fascial rupture  1  1/619 (0.16%)  1 0/617 (0.00%)  0 0/607 (0.00%)  0
Femur fracture  1  1/619 (0.16%)  1 0/617 (0.00%)  0 0/607 (0.00%)  0
Limb injury  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  1
Post procedural haemorrhage  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  1
Road traffic accident  1  1/619 (0.16%)  1 0/617 (0.00%)  0 0/607 (0.00%)  0
Spinal compression fracture  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  1
Toxicity to various agents  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  1
Investigations       
Haemoglobin decreased  1  0/619 (0.00%)  0 1/617 (0.16%)  1 0/607 (0.00%)  0
Metabolism and nutrition disorders       
Cachexia  1  1/619 (0.16%)  1 0/617 (0.00%)  0 0/607 (0.00%)  0
Hyperglycaemia  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  1
Hypokalaemia  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  1
Hypovalaemia  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  1
Type II diabetes mellitus  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  1
Musculoskeletal and connective tissue disorders       
Lumbar spinal stenosis  1  1/619 (0.16%)  1 1/617 (0.16%)  1 0/607 (0.00%)  0
Osteoarthritis  1  0/619 (0.00%)  0 1/617 (0.16%)  1 1/607 (0.16%)  1
Musculoskeletal chest pain  1  0/619 (0.00%)  0 1/617 (0.16%)  1 0/607 (0.00%)  0
Musculoskeletal pain  1  0/619 (0.00%)  0 1/617 (0.16%)  1 0/607 (0.00%)  0
Spinal osteoarthritis  1  0/619 (0.00%)  0 1/617 (0.16%)  1 0/607 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Lung neoplasm malignant  1  2/619 (0.32%)  2 1/617 (0.16%)  1 1/607 (0.16%)  1
Adenocarcinoma  1  0/619 (0.00%)  0 1/617 (0.16%)  1 0/607 (0.00%)  0
Bladder neoplasm  1  1/619 (0.16%)  1 0/617 (0.00%)  0 0/607 (0.00%)  0
Breast cancer  1  0/619 (0.00%)  0 1/617 (0.16%)  1 0/607 (0.00%)  0
Cervix carcinoma stage III  1  0/619 (0.00%)  0 1/617 (0.16%)  1 0/607 (0.00%)  0
Colon cancer  1  1/619 (0.16%)  1 0/617 (0.00%)  0 0/607 (0.00%)  0
Endometrial cancer  1  0/619 (0.00%)  0 1/617 (0.16%)  1 0/607 (0.00%)  0
Hepatic Cancer  1  1/619 (0.16%)  1 0/617 (0.00%)  0 0/607 (0.00%)  0
Lung adenocarcinoma  1  1/619 (0.16%)  1 0/617 (0.00%)  0 0/607 (0.00%)  0
Lung adenocarcinoma stage III  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  1
Lung cancer metastatic  1  0/619 (0.00%)  0 1/617 (0.16%)  1 0/607 (0.00%)  0
Mantle cell lymphoma  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  1
Metastatic neoplasm  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  1
Pancreatic carcinoma  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  1
Prostate cancer  1  1/619 (0.16%)  1 0/617 (0.00%)  0 0/607 (0.00%)  0
Nervous system disorders       
Brain injury  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  1
Carotid artery stenosis  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  1
Cervical radiculopathy  1  1/619 (0.16%)  1 0/617 (0.00%)  0 0/607 (0.00%)  0
Diabetic neuropathy  1  0/619 (0.00%)  0 1/617 (0.16%)  1 0/607 (0.00%)  0
Epilepsy  1  0/619 (0.00%)  0 1/617 (0.16%)  1 0/607 (0.00%)  0
Vascular encephalopathy  1  1/619 (0.16%)  1 0/617 (0.00%)  0 0/607 (0.00%)  0
Psychiatric disorders       
Mental status change  1  1/619 (0.16%)  1 1/617 (0.16%)  1 1/607 (0.16%)  1
Alcohol withdrawal syndrome  1  0/619 (0.00%)  0 1/617 (0.16%)  1 0/607 (0.00%)  0
Depression  1  0/619 (0.00%)  0 1/617 (0.16%)  1 0/607 (0.00%)  0
Renal and urinary disorders       
Acute kidney injury  1  0/619 (0.00%)  0 1/617 (0.16%)  1 2/607 (0.33%)  2
Hydronephrosis  1  1/619 (0.16%)  1 0/617 (0.00%)  0 0/607 (0.00%)  0
Nephrolithiasis  1  1/619 (0.16%)  1 0/617 (0.00%)  0 0/607 (0.00%)  0
Renal tubular acidosis  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  1
Ureteric obstruction  1  1/619 (0.16%)  1 0/617 (0.00%)  0 0/607 (0.00%)  0
Ureterolithiasis  1  1/619 (0.16%)  1 0/617 (0.00%)  0 0/607 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  27/619 (4.36%)  32 30/617 (4.86%)  33 50/607 (8.24%)  65
Acute respiratory failure  1  2/619 (0.32%)  2 2/617 (0.32%)  2 6/607 (0.99%)  6
Respiratory failure  1  1/619 (0.16%)  1 1/617 (0.16%)  1 1/607 (0.16%)  4
Dyspnoea  1  0/619 (0.00%)  0 2/617 (0.32%)  2 1/607 (0.16%)  1
Pneumothorax  1  0/619 (0.00%)  0 2/617 (0.32%)  2 1/607 (0.16%)  1
Hypercapnia  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  1
Hypoxia  1  1/619 (0.16%)  1 0/617 (0.00%)  0 0/607 (0.00%)  0
Pneumonia aspiration  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  1
Pneumonitis  1  1/619 (0.16%)  1 0/617 (0.00%)  0 0/607 (0.00%)  0
Pulmonary alveolar haemorrhage  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  1
Pulmonary embolism  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  1
Respiratory distress  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  1
Vascular disorders       
Deep vein thrombosis  1  1/619 (0.16%)  1 0/617 (0.00%)  0 1/607 (0.16%)  1
Peripheral vascular disease  1  0/619 (0.00%)  0 1/617 (0.16%)  1 1/607 (0.16%)  1
Arteriosclerosis  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  1
Circulatory collapse  1  0/619 (0.00%)  0 1/617 (0.16%)  1 0/607 (0.00%)  0
Hypertensive crisis  1  1/619 (0.16%)  1 0/617 (0.00%)  0 0/607 (0.00%)  0
Peripheral arterial occlusive disease  1  1/619 (0.16%)  1 0/617 (0.00%)  0 0/607 (0.00%)  0
Peripheral artery aneurysm  1  1/619 (0.16%)  1 0/617 (0.00%)  0 0/607 (0.00%)  0
Vasculitis  1  0/619 (0.00%)  0 0/617 (0.00%)  0 1/607 (0.16%)  1
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
BFF MDI 320/9.6 ug BFF MDI 160/9.6 ug FF MDI 9.6 ug
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   266/619 (42.97%)      279/617 (45.22%)      268/607 (44.15%)    
Gastrointestinal disorders       
Diarrhoea  1  13/619 (2.10%)  14 10/617 (1.62%)  11 10/607 (1.65%)  11
Infections and infestations       
Nasopharyngitis  1  41/619 (6.62%)  53 53/617 (8.59%)  61 36/607 (5.93%)  43
Upper respiratory tract infection  1  28/619 (4.52%)  29 14/617 (2.27%)  18 24/607 (3.95%)  28
Pneumonia  1  14/619 (2.26%)  14 19/617 (3.08%)  20 15/607 (2.47%)  15
Influenza  1  15/619 (2.42%)  15 19/617 (3.08%)  20 10/607 (1.65%)  10
Bronchitis  1  11/619 (1.78%)  11 13/617 (2.11%)  15 10/607 (1.65%)  14
Sinusitis  1  9/619 (1.45%)  9 9/617 (1.46%)  11 13/607 (2.14%)  13
Acute sinusitis  1  2/619 (0.32%)  2 6/617 (0.97%)  10 12/607 (1.98%)  17
Oral candidiasis  1  13/619 (2.10%)  16 6/617 (0.97%)  7 7/607 (1.15%)  8
Urinary tract infection  1  10/619 (1.62%)  12 18/617 (2.92%)  20 13/607 (2.14%)  15
Musculoskeletal and connective tissue disorders       
Back pain  1  15/619 (2.42%)  21 17/617 (2.76%)  17 11/607 (1.81%)  13
Nervous system disorders       
Headache  1  16/619 (2.58%)  24 19/617 (3.08%)  24 18/607 (2.97%)  20
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  27/619 (4.36%)  32 30/617 (4.86%)  33 50/607 (8.24%)  65
Dyspnoea  1  23/619 (3.72%)  23 16/617 (2.59%)  19 16/607 (2.64%)  18
Cough  1  14/619 (2.26%)  15 15/617 (2.43%)  17 9/607 (1.48%)  9
Vascular disorders       
Hypertension  1  15/619 (2.42%)  15 15/617 (2.43%)  15 14/607 (2.31%)  14
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Layout table for Results Point of Contact information
Name/Title: Paul M. Dorinsky, MD
Organization: Pearl Therapeutics, a Member of the AstraZeneca Group
Phone: 650-305-2600
EMail: paul.dorinsky1@astrazeneca.com
Layout table for additonal information
Responsible Party: Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02727660     History of Changes
Other Study ID Numbers: PT009003
First Submitted: March 30, 2016
First Posted: April 4, 2016
Results First Submitted: May 22, 2019
Results First Posted: September 26, 2019
Last Update Posted: September 26, 2019