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Trial record 67 of 857 for:    ALBUTEROL

Assessment of the Safety, Efficacy, PK, and Extrapulmonary Pharmacodynamics (PD) of Albuterol Sulfate Pressurized Inhalation Suspension (Hereafter Referred to as AS MDI) Compared to Proventil as an Active Control in Subjects With Asthma

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ClinicalTrials.gov Identifier: NCT03371459
Recruitment Status : Completed
First Posted : December 13, 2017
Results First Posted : July 23, 2019
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: AS MDI
Drug: Proventil
Enrollment 46
Recruitment Details  
Pre-assignment Details Subjects who met all screening and randomization requirements were eligible for rand to Tx Period, comprised of Visits 2 and 3 . Eligible subj were rand via IWRS to receive 2 cumulative-dose Tx’s in one of 2 possible Tx sequences: AS MDI, given as 1+1+2+4+8 actuations of AS MDI 90 μg, Proventil, given as 1+1+2+4+8 actuations of Proventil 90 μg
Arm/Group Title Treatment Sequence A Treatment Sequence B
Hide Arm/Group Description AS MDI 90 ug then Proventil 90 ug Proventil 90 ug then AS MDI 90 ug
Period Title: Period 1
Started 23 23
Completed 23 23
Not Completed 0 0
Period Title: Washout
Started 23 23
Completed 23 22
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
Period Title: Period 2
Started 23 22
Completed 23 22
Not Completed 0 0
Arm/Group Title mITT Population
Hide Arm/Group Description The mITT Analysis Set is defined as a subset of the ITT Analysis Set including subjects who received treatment and had post-treatment efficacy data from both Treatment Periods. Data judged to be impacted by major protocol deviations are determined prior to database lock in a blinded fashion and excluded per the statistical protocol deviation plan. Statistical tabulations and analyses are by randomized treatment, but data obtained after subjects received an incorrect treatment are excluded from the affected periods
Overall Number of Baseline Participants 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Least Squares Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants
34.2  (7.4)
[1]
Measure Analysis Population Description: mITT Population
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Female
22
  48.9%
Male
23
  51.1%
[1]
Measure Analysis Population Description: mITT Population
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Hispanic or Latino
7
  15.6%
Not Hispanic or Latino
38
  84.4%
Unknown or Not Reported
0
   0.0%
[1]
Measure Analysis Population Description: mITT Population
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 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
11
  24.4%
White
34
  75.6%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
[1]
Measure Analysis Population Description: mITT Population
1.Primary Outcome
Title Baseline-adjusted FEV1 30 Minutes After Each Cumulative Dose
Hide Description Forced expiratory volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation
Time Frame At the two study treatment visits, FEV1 (forced expiratory volume in 1 second) will be measured prior to drug administration and 5 times, once at 30 minutes after each of the 5 doses
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AS MDI Proventil
Hide Arm/Group Description:
AS MDI 90 μg 1+1+2+4+8 inhalations of 90 μg per inhalation
Proventil 1+1+2+4+8 inhalations of 90 μg per inhalation
Overall Number of Participants Analyzed 45 45
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liter
Dose 1 - 90 μg
0.421
(0.300 to 0.543)
0.488
(0.367 to 0.610)
Cumulative Dose - 180 μg
0.548
(0.432 to 0.665)
0.586
(0.469 to 0.702)
Cumulative Dose - 360 μg
0.619
(0.502 to 0.737)
0.647
(0.529 to 0.765)
Cumulative Dose - 720 μg
0.659
(0.544 to 0.775)
0.690
(0.575 to 0.805)
Cumulative Dose - 1440 μg
0.721
(0.602 to 0.840)
0.805
(0.686 to 0.925)
2.Secondary Outcome
Title Baseline-adjusted FEV1 AUC0-6 After the Last Cumulative Dose
Hide Description The baseline-adjusted FEV1 AUC0-6 is the area under the curve for change from baseline calculated using the trapezoidal rule and normalized by dividing the AUC by the length of follow up post the last cumulative dose (typically 6 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 6 hours post dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AS MDI Proventil
Hide Arm/Group Description:
AS MDI 90 μg 1+1+2+4+8 inhalations of 90 μg per inhalation
Proventil 1+1+2+4+8 inhalations of 90 μg per inhalation
Overall Number of Participants Analyzed 45 45
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liter
0.561
(0.448 to 0.674)
0.602
(0.489 to 0.715)
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 until study completion for a maximum of 44 days. This reporting time frame includes the screening period, the two active treatment periods, and the follow up period (i.e. 3-7 days after last dose of study drug).
 
Arm/Group Title AS MDI Proventil
Hide Arm/Group Description AS MDI 90 μg 1+1+2+4+8 inhalations of 90 μg per inhalation Proventil 1+1+2+4+8 inhalations of 90 μg per inhalation
All-Cause Mortality
AS MDI Proventil
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)      0/46 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
AS MDI Proventil
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/45 (0.00%)      0/46 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
AS MDI Proventil
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/45 (17.78%)      10/46 (21.74%)    
Gastrointestinal disorders     
Vomiting  1  1/45 (2.22%)  1 0/46 (0.00%)  0
General disorders     
Feeling Jittery  1 [1]  3/45 (6.67%)  3 6/46 (13.04%)  6
Investigations     
Blood Potassium decreased  1  0/45 (0.00%)  0 1/46 (2.17%)  1
Nervous system disorders     
Tremor  1 [1]  2/45 (4.44%)  2 2/46 (4.35%)  2
Headache  1 [1]  2/45 (4.44%)  2 0/46 (0.00%)  0
Dizziness  1  1/45 (2.22%)  1 0/46 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Epistaxis  1  0/45 (0.00%)  0 1/46 (2.17%)  1
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
[1]
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 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: NCT03371459     History of Changes
Other Study ID Numbers: D6930C00002
First Submitted: December 1, 2017
First Posted: December 13, 2017
Results First Submitted: March 26, 2019
Results First Posted: July 23, 2019
Last Update Posted: July 23, 2019