Clinical trial NCT01058863: A Dose-ranging Study to Evaluate Albuterol and Hydrofluoroalkane in Subjects Ages 12 and Older With Persistent Asthma
Official title: A Double-blind, Randomized, Placebo-controlled, 5-way Crossover, Multicenter, Single-dose, Dose-ranging Study to Compare the Efficacy and Safety of Albuterol Spiromax® and ProAir® HFA in Adult and Adolescent Subjects Ages 12 and Older With Persistent Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2010-01-29
Enrollment: 72
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is examining how well a dry powder inhaler (DPI) of albuterol medication works to help adult and adolescent subjects 12 years of age and older with persistent asthma to improve lung function.


Eligibility criteria: Inclusion Criteria:

* Must provide written informed consent,
* Be between 12 years of age and older,
* Male or Female, females of non-child bearing potential or using reliable contraception
* Asthma for at least 6 months, FEV1 (forced expiratory volume in 1 second) between 50-80% of predicted value, and reversibility greater than or equal to 15% following 180 mcg albuterol
* Stable low dose of Inhaled Corticosteroids
* Non-smoker, 12 months smoking-free and \<=10-pack years history
* Otherwise healthy
* Other criteria apply

Exclusion Criteria:

* Pregnant
* Allergic to albuterol or severe milk protein allergy
* Must not be on another trial for 30days.
* Other criteria apply

Primary outcomes:
measure: Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6)
timeFrame: Day 1 up to Day 30
Secondary outcomes:
measure: Baseline-adjusted Percent-Predicted Forced Expiratory Volume in 1 Second (PPFEV1) Area Under the Curve (AUC 0-6)
timeFrame: Day 1 up to Day 30
measure: Participants With Treatment-Emergent Adverse Events
timeFrame: Day 1 up to Day 37
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: Teva Clinical Study Site
state: California
city: Rolling Hills Est.
country: United States
facility: Teva Clinical Study Site
state: California
city: San Diego
country: United States
facility: Teva Clinical Study Site
state: California
city: Colorado Springs
country: United States
facility: Teva Clinical Study Site
state: Colorado
city: Margate
country: United States
facility: Teva Clinical Study Site
state: Florida
city: Miami
country: United States
facility: Teva Clinical Study Site
state: Florida
city: Saint Louis
country: United States
facility: Teva Clinical Study Site
state: Missouri
city: Skillman
country: United States
facility: Teva Clinical Study Site
state: New Jersey
city: Raleigh
country: United States
facility: Teva Clinical Study Site
state: North Carolina
city: Cincinnati
country: United States
facility: Teva Clinical Study Site
state: Ohio
city: Dayton
country: United States
facility: Teva Clinical Study Site
state: Ohio
city: Medford
country: United States
facility: Teva Clinical Study Site
state: Oregon
city: Portland
country: United States
facility: Teva Clinical Study Site
state: Oregon
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Study Leader
role: STUDY_DIRECTOR
References: