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COMPLETEDPHASE3

Efficacy of Inhaled Albuterol Spiromax® in Subjects With Persistent Asthma With Steady State Pharmacokinetics

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

NCT01747629•Teva Branded Pharmaceutical Products R&D, Inc.

View on ClinicalTrials.gov

Summary

The primary objective of this study is to evaluate the efficacy of Albuterol Spiromax® versus placebo in subjects with persistent asthma.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Written informed consent/assent
•At least 12 years of age at screening
•General good health
•Persistent asthma for ≥3 months, with an FEV1 50-80% predicted and ≥15% reversibility
•Taking inhaled corticosteroids at a stable dose (≤ equivalent of 500mcg of fluticasone propionate/day) for at least 4 weeks prior to the Screening Visit.
•Ability to perform spirometry in an acceptable manner as per protocol guidelines

Exclusion Criteria

•A known hypersensitivity to albuterol or any of the excipients in the formulations.
•History of a respiratory infection or disorder that has not resolved within 1 week preceding the Screening Visit (SV).
•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 SV. A subject must not have had any hospitalization for asthma within 6 months prior to the SV.
•Hospitalization due to asthma exacerbation 2 or more times in the past year
•Initiation of immunotherapy or dose escalation during the study period

Locations (35)

Teva Investigational Site 10225

Costa Mesa, California, United States

Teva Investigational Site 10250

Encinitas, California, United States

Teva Investigational Site 10230

Huntington Beach, California, United States

Teva Investigational Site 10255

Palmdale, California, United States

Teva Investigational Site 10231

Rancho Mirage, California, United States

Teva Investigational Site 10252

Riverside, California, United States

Teva Investigational Site 10242

Rolling Hills Estates, California, United States

Teva Investigational Site 10238

San Diego, California, United States

Teva Investigational Site 10243

San Jose, California, United States

Teva Investigational Site 10247

Miami Lakes, Florida, 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

160

ACTUAL participants

Conditions

Asthma

Interventions

Placebo MDPI

DRUG

Albuterol MDPI

DRUG

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

NCT07486401

Asthma ExacerbationsBiomarkers / Blood+1 more

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RECRUITINGPHASE2

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

NCT07219173

Asthma

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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.

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Efficacy of Inhaled Albuterol Spiromax® in Subjects With Persistent Asthma With Steady State Pharmacokinetics

Inclusion Criteria

Exclusion Criteria

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

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

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