Clinical trial NCT01424813: A 12-week Study to Compare the Efficacy and Safety of Albuterol Spiromax® Versus a Placebo in People 12 Years and Older With Persistent Asthma
Official title: A 12-week Comparison of the Efficacy and Safety of Albuterol Spiromax® Versus Placebo in Subjects 12 Years and Older With Persistent Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
dry powder inhaler
short-acting beta2-agonist
SABA
bronchoconstriction
bronchodilation
bronchodilator
metered dose inhaler
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2011-08-29
Enrollment: 158
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will measure the change in lung function in subjects with asthma after inhaling from either of two inhalers: Albuterol Spiromax® or placebo.


Eligibility criteria: Inclusion Criteria:

* Written informed consent/assent
* General good health
* Persistent asthma, with an FEV1 50-80% predicted.
* Ability to perform spirometry in an acceptable manner as per protocol guidelines.
* Ability to perform PEFR with a handheld peak flow meter.
* Demonstration of reversible bronchoconstriction as verified by a 15% or greater increase from baseline FEV1.
* Taking inhaled corticosteroids at a stable dose for at least 4 weeks prior to the Screening Visit.
* Non-smokers.
* Capable of understanding the requirements, risks, and benefits of study participation.
* Other inclusion criteria apply.

Exclusion Criteria:

* Participation in any investigational drug trial within the 30 days preceding the Screening Visit (SV).
* A known hypersensitivity to albuterol or any of the excipients in the formulations.
* History of severe milk protein allergy.
* History of a respiratory infection or disorder that has not resolved within the 2 weeks preceding the Screening Visit (SV).
* Currently requires treatment with β2-adrenergic receptor antagonists or non-selective β-receptor blocking agents.
* History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation.
* Any asthma exacerbation requiring oral corticosteroids within 3 months of the Screening Visit (SV). A subject must not have had any hospitalization for asthma within 6 months prior to the Screening Visit (SV).
* Historical or current evidence of any clinically significant non-asthmatic acute or chronic condition including.
* Other exclusion criteria apply.

Primary outcomes:
measure: Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) Over the 12-week Treatment Period
timeFrame: Day 1, Day 8 and Day 85
Secondary outcomes:
measure: Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 1
timeFrame: Day 1
measure: Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 8
timeFrame: Day 8
measure: Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 85
timeFrame: Day 85
measure: Participants With Adverse Events
timeFrame: Day 1 to Day 92
measure: Physical Examination Findings Shifts From Baseline to Endpoint by Treatment Group
timeFrame: Day 1 (Baseline), Day 85
measure: Participants With Clinically Significant Vital Sign Assessments
timeFrame: Day 8, Day 85
Other outcomes:
measure: Percent Change From Baseline in FEV1 AUC 0-6 Over the 12-week Treatment Period
timeFrame: Day 1, Day 8, Day 85
measure: Percent Change From Baseline in FEV1 AUC 0-6
timeFrame: Day 1
measure: Percent Change From Baseline in FEV1 AUC
timeFrame: Day 8
measure: Percent Change From Baseline in FEV1 AUC
timeFrame: Day 85
measure: Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose Over the 12-week Treatment Period
timeFrame: Day 1, Day 8, Day 85
measure: Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 1
timeFrame: Day 1
measure: Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 8
timeFrame: Day 8
measure: Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 85
timeFrame: Day 85
measure: Time to Onset of Effect (Change in FEV1 of 12% From Baseline Within 30 Minutes Postdose)
timeFrame: Day 1, Day 8, Day 85
measure: Duration of Response Measured From the Time Post-dosing to the First Time After the Response Onset (Increase ≥12% Above Baseline) When the FEV1 Decreases to Less Than 12% Above Baseline (Within 6 Hours After Dosing) for Those Who Responded in 30 Minutes
timeFrame: Day 1, Day 8, Day 85
measure: Time to Onset of Effect (Change in FEV1 of 15% From Baseline Within 30 Minutes Postdose)for Those Who Responded in 30 Minutes
timeFrame: Day 1, Day 8, Day 85
measure: Duration of Response on Days 1, 8 and 85
timeFrame: Day 1, Day 8, Day 85
measure: Percent of Symptom Free Days on the Patient Diary
timeFrame: Treatment days 1 through 85
measure: Percent of Rescue Medication Free Days in the Patient Diary
timeFrame: Treatment days 1 through 85
measure: Morning Peak Expiratory Flow Reading Reported on Patient Diary
timeFrame: Treatment days 1 through 85
Locations:
city: Birmingham
country: United States
facility: Teva Investigational Site 10077
state: Alabama
city: Phoenix
country: United States
facility: Teva Investigational Site 10079
state: Arizona
city: Costa Mesa
country: United States
facility: Teva Investigational Site 10569
state: California
city: Fountain Valley
country: United States
facility: Teva Investigational Site 10053
state: California
city: Huntington Beach
country: United States
facility: Teva Investigational Site 10065
state: California
city: Huntington Beach
country: United States
facility: Teva Investigational Site 10572
state: California
city: Los Angeles
country: United States
facility: Teva Investigational Site 10075
state: California
city: Roseville
country: United States
facility: Teva Investigational Site 10061
state: California
city: San Diego
country: United States
facility: Teva Investigational Site 10066
state: California
city: Denver
country: United States
facility: Teva Investigational Site 10068
state: Colorado
city: Denver
country: United States
facility: Teva Investigational Site 10069
state: Colorado
city: Miami
country: United States
facility: Teva Investigational Site 10058
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 10060
state: Florida
city: Ormond Beach
country: United States
facility: Teva Investigational Site 10064
state: Florida
city: Savannah
country: United States
facility: Teva Investigational Site 10071
state: Georgia
city: Wichita
country: United States
facility: Teva Investigational Site 10073
state: Kansas
city: Owensboro
country: United States
facility: Teva Investigational Site 10070
state: Kentucky
city: Bethesda
country: United States
facility: Teva Investigational Site 10063
state: Maryland
city: Gaithersburg
country: United States
facility: Teva Investigational Site 10571
state: Maryland
city: Wheaton
country: United States
facility: Teva Investigational Site 10067
state: Maryland
city: St. Louis
country: United States
facility: Teva Investigational Site 10072
state: Missouri
city: Missoula
country: United States
facility: Teva Investigational Site 10050
state: Montana
city: Raleigh
country: United States
facility: Teva Investigational Site 10057
state: North Carolina
city: Cincinnati
country: United States
facility: Teva Investigational Site 10051
state: Ohio
city: Sylvania
country: United States
facility: Teva Investigational Site 10078
state: Ohio
city: Oklahoma City
country: United States
facility: Teva Investigational Site 10054
state: Oklahoma
city: Oklahoma City
country: United States
facility: Teva Investigational Site 10568
state: Oklahoma
city: Tulsa
country: United States
facility: Teva Investigational Site 10055
state: Oklahoma
city: Medford
country: United States
facility: Teva Investigational Site 10056
state: Oregon
city: Medford
country: United States
facility: Teva Investigational Site 10076
state: Oregon
city: Charleston
country: United States
facility: Teva Investigational Site 10684
state: South Carolina
city: Spartanburg
country: United States
facility: Teva Investigational Site 10570
state: South Carolina
city: Live Oak
country: United States
facility: Teva Investigational Site 10049
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 10052
state: Texas
city: Waco
country: United States
facility: Teva Investigational Site 10685
state: Texas
city: Fairfax
country: United States
facility: Teva Investigational Site 10059
state: Virginia
city: Puyallup
country: United States
facility: Teva Investigational Site 10074
state: Washington
city: Tacoma
country: United States
facility: Teva Investigational Site 10062
state: Washington
Study officials:
affiliation: Teva Respiratory R&D
name: Clinical Project Leader
role: STUDY_DIRECTOR
References:
citation: Raphael G, Taveras H, Iverson H, O'Brien C, Miller D. Twelve- and 52-week safety of albuterol multidose dry powder inhaler in patients with persistent asthma. J Asthma. 2016;53(2):187-93. doi: 10.3109/02770903.2015.1070862. Epub 2015 Sep 15.