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Study to Compare PT007 to Placebo MDI and Open-Label Proventil® HFA in Adult and Adolescent Subjects With Asthma

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ClinicalTrials.gov Identifier: NCT03364608
Recruitment Status : Completed
First Posted : December 6, 2017
Results First Posted : July 24, 2019
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: AS MDI 90 μg
Drug: AS MDI 180 µg
Other: Placebo MDI
Drug: Proventil 90 μg
Drug: Proventil 180 μg
Enrollment 86
Recruitment Details This study was conducted at 10 sites in the United States, from December 2017 to March 2018. The study was anticipated to run for at least 23 days but not to exceed 68 days.
Pre-assignment Details Subjects were randomized into one of 10 treatment sequences. Each sequence comprised all 5 treatments included in this study (ie, AS MDI 90 μg, AS MDI 180 μg, Placebo MDI, Proventil 90 μg, and Proventil 180 μg) in a randomized order
Arm/Group Title Subjects
Hide Arm/Group Description ITT Analysis set
Period Title: Overall Study
Started [1] 86
Placebo MDI [2] 82
AS MDI 90 µg [3] 81
AS MDI 180 µg [4] 81
Proventil 90 µg [5] 82
Proventil 180 µg [4] 79
Completed 78
Not Completed 8
Reason Not Completed
Withdrawal by Subject             4
Protocol Violation             2
Lost to Follow-up             2
[1]
ITT Analysis Set
[2]
(2 actuations)
[3]
(2 actuations of 45 µg/actuation)
[4]
(2 actuations of 90 µg/actuation)
[5]
(1 actuation of 90 µg/actuation)
Arm/Group Title Overall Study
Hide Arm/Group Description Safety Set
Overall Number of Baseline Participants 86
Hide Baseline Analysis Population Description
Overall number of Baseline Participants is from the Safety set.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 86 participants
42.7  (13.4)
[1]
Measure Analysis Population Description: Safety Set
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants
Female
47
  54.7%
Male
39
  45.3%
[1]
Measure Analysis Population Description: Safety Set
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants
Hispanic or Latino
14
  16.3%
Not Hispanic or Latino
72
  83.7%
Unknown or Not Reported
0
   0.0%
[1]
Measure Analysis Population Description: Safety Set
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   1.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
20
  23.3%
White
62
  72.1%
More than one race
0
   0.0%
Unknown or Not Reported
3
   3.5%
[1]
Measure Analysis Population Description: Safety Set
1.Primary Outcome
Title Change From Baseline in FEV1 AUC0-6
Hide Description Change from baseline in FEV1 (Forced expiratory volume in 1 second) AUC0-6 (Area under the curve from 0 to 6 hours) (spirometry will be obtained at 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose) normalized for length of follow up.
Time Frame Over 6 hours post dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title AS MDI 180 µg AS MDI 90 µg Proventil 180 µg Proventil 90 µg Placebo MDI
Hide Arm/Group Description:
(2 actuations of 90 µg/actuation)
(2 actuations of 45 µg/actuation)
(2 actuations of 90 µg/actuation)
(1 actuation of 90 µg/actuation)
(2 actuations)
Overall Number of Participants Analyzed 79 79 77 78 78
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters
0.266
(0.219 to 0.313)
0.203
(0.156 to 0.251)
0.282
(0.234 to 0.329)
0.240
(0.193 to 0.288)
0.070
(0.022 to 0.117)
2.Secondary Outcome
Title Change From Baseline in FEV1 AUC0-4
Hide Description Change from baseline in FEV1 (Forced expiratory volume in 1 second) AUC0-4 (Area under the curve from 0 to 4 hours) (spirometry will be obtained at 5, 15, 30, 45, 60, 120, 180, and 240 minutes post-dose) normalized for length of follow up.
Time Frame Over 4 hours post dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title AS MDI 180 µg AS MDI 90 µg Proventil 180 µg Proventil 90 µg Placebo MDI
Hide Arm/Group Description:
(2 actuations of 90 µg/actuation)
(2 actuations of 45 µg/actuation)
(2 actuations of 90 µg/actuation)
(1 actuation of 90 µg/actuation)
(2 actuations)
Overall Number of Participants Analyzed 79 79 77 78 78
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters
0.331
(0.280 to 0.381)
0.263
(0.213 to 0.313)
0.349
(0.299 to 0.400)
0.297
(0.247 to 0.348)
0.080
(0.030 to 0.131)
3.Secondary Outcome
Title Peak Change From Baseline in FEV1
Hide Description Peak Change from baseline in FEV1 (Forced expiratory volume in 1 second)
Time Frame Over 6 hours post dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title AS MDI 180 µg AS MDI 90 µg Proventil 180 µg Proventil 90 µg Placebo MDI
Hide Arm/Group Description:
(2 actuations of 90 µg/actuation)
(2 actuations of 45 µg/actuation)
(2 actuations of 90 µg/actuation)
(1 actuation of 90 µg/actuation)
(2 actuations)
Overall Number of Participants Analyzed 79 79 77 78 78
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters
0.509
(0.451 to 0.567)
0.433
(0.375 to 0.491)
0.516
(0.458 to 0.574)
0.472
(0.414 to 0.530)
0.233
(0.176 to 0.291)
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 68 days, which includes screening and follow up (3-7 days after last dose of study drug).
 
Arm/Group Title Placebo MDI AS MDI 90 µg Proventil 180 µg Proventil 90 µg • Proventil 180 µg
Hide Arm/Group Description (2 actuations) (2 actuations of 45 µg/actuation) (2 actuations of 90 µg/actuation) (1 actuation of 90 µg/actuation) (2 actuations of 90 µg/actuation)
All-Cause Mortality
Placebo MDI AS MDI 90 µg Proventil 180 µg Proventil 90 µg • Proventil 180 µg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/82 (0.00%)   0/81 (0.00%)   0/81 (0.00%)   0/82 (0.00%)   0/79 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo MDI AS MDI 90 µg Proventil 180 µg Proventil 90 µg • Proventil 180 µg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/82 (0.00%)   0/81 (0.00%)   0/81 (0.00%)   0/82 (0.00%)   0/79 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo MDI AS MDI 90 µg Proventil 180 µg Proventil 90 µg • Proventil 180 µg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/82 (0.00%)   0/81 (0.00%)   0/81 (0.00%)   0/82 (0.00%)   0/79 (0.00%) 
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: Colin Reisner, MD FCCP, FAAAAI
Organization: Pearl Therapeutics, Inc, a Member of the AstraZeneca Group
Phone: 9739750321
EMail: Colin.Reisner@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03364608     History of Changes
Other Study ID Numbers: D6930C00001
First Submitted: December 1, 2017
First Posted: December 6, 2017
Results First Submitted: March 29, 2019
Results First Posted: July 24, 2019
Last Update Posted: July 24, 2019