Loading clinical trials...

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 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A 12-week Comparison of the Efficacy and Safety of Albuterol Spiromax® Versus Placebo in Subjects 12 Years and Older With Persistent Asthma

NCT01424813•Teva Branded Pharmaceutical Products R&D, Inc.

View on ClinicalTrials.gov

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

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

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.

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.

Locations (38)

Teva Investigational Site 10077

Birmingham, Alabama, United States

Teva Investigational Site 10079

Phoenix, Arizona, United States

Teva Investigational Site 10569

Costa Mesa, California, United States

Teva Investigational Site 10053

Fountain Valley, California, United States

Teva Investigational Site 10065

Huntington Beach, California, United States

Teva Investigational Site 10572

Huntington Beach, California, United States

Teva Investigational Site 10075

Los Angeles, California, United States

Teva Investigational Site 10061

Roseville, California, United States

Teva Investigational Site 10066

San Diego, California, United States

Teva Investigational Site 10068

Denver, Colorado, United States

Key Dates

Start Date

December 1, 2012

Primary Completion Date

October 1, 2013

Completion Date

November 1, 2013

Last Updated

June 26, 2015

Enrollment

158

ACTUAL participants

Conditions

Asthma

Interventions

Placebo MDPI

DRUG

Albuterol MDPI

DRUG

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

NCT02327897

Asthma

View study

RECRUITINGNA

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NCT07486401

Asthma ExacerbationsBiomarkers / Blood+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 26, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

To Assess the Management of Patients on Global Initiative of Asthma (GINA) Step 4 and 5 Treatment in Hong Kong

A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma