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Trial record 70 of 58406 for:    Placebo

A Study to Assess the Effects of PT003 and Placebo MDI on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD

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ClinicalTrials.gov Identifier: NCT02643082
Recruitment Status : Completed
First Posted : December 30, 2015
Results First Posted : March 19, 2019
Last Update Posted : March 19, 2019
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 COPD
Interventions Drug: GFF MDI (PT003) 14.4/9.6μg
Drug: Placebo MDI
Enrollment 20
Recruitment Details This study was conducted at 1 site in Antwerp Belgium from January 2016 to December 2016.The study was anticipated to run for approximately 9 months but not to expected to exceed 12 months. The study period was duration was expected to run approximately 13 weeks for each subject.
Pre-assignment Details Subjects were randomized into 1 of 2 treatment sequences: subjects in Sequence 1 received GFF MDI in Treatment Period 1 followed by Placebo MDI in Treatment Period 2, and subjects in Sequence 2 received Placebo MDI in Treatment Period 1 followed by GFF MDI in Treatment Period 2. There was a a washout of 5-21 days,in between treatment periods.
Arm/Group Title GFF MDI/Placebo MDI Placebo MDI/GFF MDI
Hide Arm/Group Description Treatment Sequence of Glycopyrronium Formoterol Fumarate Metered Dose Inhalation/Placebo Metered Dose Inhalation Treatment Sequence of Placebo Metered Dose Inhalation/Glycopyrronium Formoterol Fumarate Metered Dose Inhalation
Period Title: Period 1
Started 10 10
Completed 9 10
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Period Title: Washout
Started 9 10
Completed 9 10
Not Completed 0 0
Period Title: Period 2
Started 9 10
Completed 9 10
Not Completed 0 0
Arm/Group Title Overall Study
Hide Arm/Group Description All Randomized Patients
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
ITT Population - all subjects who were randomized to treatment. Treatment was assigned as randomized regardless of the treatment actually received.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
64.8  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
5
  25.0%
Male
15
  75.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
20
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Specific Airway Volume (siVaw)
Hide Description Specific image-based airway volume. Average across lobe, adjusted for lobe volume
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title GFF MDI 14.4/9.6 µg Placebo MDI
Hide Arm/Group Description:
GFF MDI
Placebo
Overall Number of Participants Analyzed 20 19
Geometric Least Squares Mean (95% Confidence Interval)
Unit of Measure: mL/L
1.79
(1.48 to 2.16)
1.02
(0.85 to 1.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GFF MDI 14.4/9.6 µg, Placebo MDI
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean ratio between treatments
Estimated Value 1.75
Confidence Interval (2-Sided) 95%
1.65 to 1.86
Estimation Comments [Not Specified]
2.Primary Outcome
Title Specific Airway Resistance (siRaw)
Hide Description Specific image-based airway resistance. Average across lobes, adjusted for lobe volume
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title GFF MDI 14.4/9.6 µg Placebo MDI
Hide Arm/Group Description:
GFF MDI
Placebo
Overall Number of Participants Analyzed 20 19
Geometric Least Squares Mean (95% Confidence Interval)
Unit of Measure: kPa s
0.09
(0.07 to 0.11)
0.30
(0.23 to 0.40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GFF MDI 14.4/9.6 µg, Placebo MDI
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean ratio between treatments
Estimated Value 0.29
Confidence Interval (2-Sided) 95%
0.25 to 0.33
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Airway Resistance (iRaw)
Hide Description iRaw represents the airway resistance, averaged across lobes, without correction for lung lobe volume
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title GFF MDI 14.4/9.6 µg Placebo MDI
Hide Arm/Group Description:
GFF MDI
Placebo
Overall Number of Participants Analyzed 20 19
Geometric Least Squares Mean (95% Confidence Interval)
Unit of Measure: kPa s/L
0.07
(0.06 to 0.10)
0.25
(0.19 to 0.33)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GFF MDI 14.4/9.6 µg, Placebo MDI
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean ratio between treatments
Estimated Value 0.29
Confidence Interval (2-Sided) 95%
0.26 to 0.33
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Airway Volume (iVaw)
Hide Description iVaw represents the airway Volume, averaged across lobes, without correction for lung lobe volume
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title GFF MDI 14.4/9.6 µg Placebo MDI
Hide Arm/Group Description:
GFF MDI
Placebo
Overall Number of Participants Analyzed 20 19
Geometric Least Squares Mean (95% Confidence Interval)
Unit of Measure: mL
2.11
(1.73 to 2.58)
1.18
(0.97 to 1.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GFF MDI 14.4/9.6 µg, Placebo MDI
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean ratio between treatments
Estimated Value 1.79
Confidence Interval (2-Sided) 95%
1.67 to 1.92
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in FEV1 (L) at Day 15
Hide Description Change from baseline in Forced Expiratory Volume at 1 second
Time Frame Baseline and Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title GFF MDI 14.4/9.6 µg Placebo MDI
Hide Arm/Group Description:
GFF MDI
Placebo
Overall Number of Participants Analyzed 20 19
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters
0.334
(0.245 to 0.422)
-0.110
(-0.198 to -0.022)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GFF MDI 14.4/9.6 µg, Placebo MDI
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference Between Treatments
Estimated Value 0.443
Confidence Interval (2-Sided) 95%
0.318 to 0.569
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in FRC (L) at Day 15
Hide Description Change from baseline in Functional Residual Capacity
Time Frame Baseline and Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title GFF MDI 14.4/9.6 µg Placebo MDI
Hide Arm/Group Description:
GFF MDI
Placebo
Overall Number of Participants Analyzed 20 19
Geometric Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters
0.90
(0.86 to 0.93)
1.03
(0.99 to 1.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GFF MDI 14.4/9.6 µg, Placebo MDI
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean ratio between treatments
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.82 to 0.92
Estimation Comments [Not Specified]
Time Frame Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
Adverse Event Reporting Description The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
 
Arm/Group Title Overall Study GFF MDI 14.4/9.6 µg Placebo MDI
Hide Arm/Group Description All Randomized Patients GFF MDI Placebo
All-Cause Mortality
Overall Study GFF MDI 14.4/9.6 µg Placebo MDI
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)      0/20 (0.00%)      0/19 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Overall Study GFF MDI 14.4/9.6 µg Placebo MDI
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/20 (10.00%)      1/20 (5.00%)      1/19 (5.26%)    
Cardiac disorders       
Acute Coronary Syndrome  1  1/20 (5.00%)  1 0/20 (0.00%)  0 1/19 (5.26%)  1
Acute Myocardial Infarction  1  1/20 (5.00%)  1 1/20 (5.00%)  1 0/19 (0.00%)  0
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 5%
Overall Study GFF MDI 14.4/9.6 µg Placebo MDI
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/20 (75.00%)      12/20 (60.00%)      8/19 (42.11%)    
Cardiac disorders       
Acute Coronary Syndrome  1  1/20 (5.00%)  1 0/20 (0.00%)  0 1/19 (5.26%)  1
Acute Myocardial Infarction  1  1/20 (5.00%)  1 1/20 (5.00%)  1 0/19 (0.00%)  0
Bradycardia  1  1/20 (5.00%)  1 0/20 (0.00%)  0 1/19 (5.26%)  1
Gastrointestinal disorders       
Diarrhoea  1  1/20 (5.00%)  2 1/20 (5.00%)  1 1/19 (5.26%)  1
Toothache  1  1/20 (5.00%)  1 0/20 (0.00%)  0 1/19 (5.26%)  1
General disorders       
Oedema  1  1/20 (5.00%)  1 1/20 (5.00%)  1 0/19 (0.00%)  0
Infections and infestations       
Respiratory Tract Infection  1  2/20 (10.00%)  2 2/20 (10.00%)  2 0/19 (0.00%)  0
Pneumonia  1  1/20 (5.00%)  1 1/20 (5.00%)  1 0/19 (0.00%)  0
Metabolism and nutrition disorders       
Iron Defficiency  1  1/20 (5.00%)  1 0/20 (0.00%)  0 1/19 (5.26%)  1
Musculoskeletal and connective tissue disorders       
Musculoskeletal Pain  1  1/20 (5.00%)  1 0/20 (0.00%)  0 1/19 (5.26%)  1
Nervous system disorders       
Dizziness  1  2/20 (10.00%)  2 2/20 (10.00%)  2 0/19 (0.00%)  0
Headache  1  2/20 (10.00%)  3 2/20 (10.00%)  2 1/19 (5.26%)  1
Tremor  1  2/20 (10.00%)  3 2/20 (10.00%)  2 1/19 (5.26%)  1
Dysgeusia  1  1/20 (5.00%)  1 1/20 (5.00%)  1 0/19 (0.00%)  0
Renal and urinary disorders       
Renal Mass  1  1/20 (5.00%)  1 0/20 (0.00%)  0 1/19 (5.26%)  1
Renal Pain  1  1/20 (5.00%)  1 0/20 (0.00%)  0 1/19 (5.26%)  1
Respiratory, thoracic and mediastinal disorders       
Dyspnoea exertional  1  3/20 (15.00%)  3 0/20 (0.00%)  0 3/19 (15.79%)  3
Dyspnoea  1  2/20 (10.00%)  2 2/20 (10.00%)  2 0/19 (0.00%)  0
Obstructive Airway Disorder  1  1/20 (5.00%)  1 0/20 (0.00%)  0 1/19 (5.26%)  1
Pulmonary Mass  1  1/20 (5.00%)  2 1/20 (5.00%)  2 0/19 (0.00%)  0
Rales  1  1/20 (5.00%)  1 1/20 (5.00%)  1 0/19 (0.00%)  0
Vascular disorders       
Hypertension  1  1/20 (5.00%)  1 1/20 (5.00%)  1 0/19 (0.00%)  0
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
Name/Title: Pearl Therapeutics, Inc.
Organization: Pearl Therapeutics, Inc.
Phone: 650-305-2600
Responsible Party: Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02643082     History of Changes
Obsolete Identifiers: NCT03024346
Other Study ID Numbers: PT003018
First Submitted: December 10, 2015
First Posted: December 30, 2015
Results First Submitted: January 26, 2018
Results First Posted: March 19, 2019
Last Update Posted: March 19, 2019