A Dose-ranging Study to Evaluate Albuterol and Hydrofluoroalkane in Subjects Ages 12 and Older With Persistent Asthma

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01058863
• Other study ID #: ABS-AS-201
• Status: Completed
• Phase: Phase 2
• Start date: February 2010
• Est. completion date: June 2010

Study information

• Verified date: November 2021
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Albuterol Spiromax®
Albuterol Spiromax® delivers 90 mcg albuterol per inhalation. Doses of 180 mcg require two inhalations. Intervention given as double-blind medication on 2 of 5 treatment days, once at 90 mcg and once at 180 mcg.
• ProAir® HFA
ProAir® HFA delivers 90 mcg of albuterol per inhalation. Doses of 180 mcg require two inhalations. Intervention given as double-blind medication on 2 of 5 treatment days, once at 90 mcg and once at 180 mcg.

Other:
• Placebo Inhaler
Placebo delivered in both the Spiromax® and HFA inhalers to maintain the blind and also to support the placebo treatment arm.

Locations

Country	Name	City	State
United States	Teva Clinical Study Site	Cincinnati	Ohio
United States	Teva Clinical Study Site	Colorado Springs	Colorado
United States	Teva Clinical Study Site	Dayton	Ohio
United States	Teva Clinical Study Site	Huntington Beach	California
United States	Teva Clinical Study Site	Margate	Florida
United States	Teva Clinical Study Site	Medford	Oregon
United States	Teva Clinical Study Site	Miami	Florida
United States	Teva Clinical Study Site	Portland	Oregon
United States	Teva Clinical Study Site	Raleigh	North Carolina
United States	Teva Clinical Study Site	Rolling Hills Est.	California
United States	Teva Clinical Study Site	Saint Louis	Missouri
United States	Teva Clinical Study Site	San Diego	California
United States	Teva Clinical Study Site	Skillman	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6)	FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline for each study day was the average of the 2 pre-dose FEV1 measurements on that study day.; The first baseline spirometry was obtained between 6-11 AM. The highest FEV1 value from two acceptable values was captured for calculation of the efficacy endpoints. Assessments were obtained at approximately 0.5 hours and immediately before dosing, and 5 minutes, 0.25, 0.50, 0.75, 1, 2, 3, 4, 5 and 6 hours after completion of dosing.	Day 1 up to Day 30
Secondary	Baseline-adjusted Percent-Predicted Forced Expiratory Volume in 1 Second (PPFEV1) Area Under the Curve (AUC 0-6)	Percent-predicted FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. Percent-predicted FEV1 is the expected FEV1 taking into account age, height, gender and race, as per the National Health and Nutrition Examination Survey III (NHANES III) reference values.; The first baseline spirometry was obtained between 6-11 AM. The highest FEV1 value from two acceptable values was captured for calculation of the efficacy endpoints. Assessments were obtained at approximately 0.5 hours and immediately before dosing, and 5 minutes, 0.25, 0.50, 0.75, 1, 2, 3, 4, 5 and 6 hours after completion of dosing.	Day 1 up to Day 30
Secondary	Participants With Treatment-Emergent Adverse Events	Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.	Day 1 up to Day 37