At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 38 enrolled

Drug / intervention

Albuterol Spiromax +1 moredrug

Likely dose

Albuterol Spiromax 90 mcgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01791972

NCT01791972Phase 3Completed

Compare CT.gov

A Single-Dose Study to Assess the Efficacy of Albuterol SPIROMAX® in Adult and Adolescent Patients With Exercise-Induced Bronchoconstriction (EIB)

Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Feb 15, 2013·Updated Jun 18, 2015

In Brief

A Phase 3 clinical trial evaluating Albuterol Spiromax and Placebo Spiromax for Exercise-Induced Bronchoconstriction (EIB). Completed, enrolled 38 participants across 6 sites.

Detailed Summary

The primary objective of this study is to evaluate the efficacy of a single dose (2 inhalations, 180 mcg total) of Albuterol SPIROMAX (90 mcg per inhalation) versus placebo in patients with EIB.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsExercise-Induced Bronchoconstriction (EIB)

CountriesUnited States

Collaborators--

Timeline

Phase 3CompletedFinished

20132014201520162017201820192020202120222023202420252026

First PostedFeb 2013

Enrollment StartMar 2013

Primary CompletionMay 2013

Study CompletionJun 2013

TodayJul 2026

First PostedFeb 15, 2013

Enrollment StartMar 1, 2013

Primary CompletionMay 1, 2013

Study CompletionJun 1, 2013

TodayJul 2, 2026

Enrollment to primary: 2 monthsPosted 13.4 years ago

Interventions

Albuterol Spiromaxdrug

Albuterol Spiromax is an inhalation-driven, multi-dose dry powder inhaler (DPI) containing a blend of albuterol sulfate with alpha-lactose monohydrate. Each actuation represents a dose of 90 mcg of albuterol sulfate. Participants received one dose of two inhalations (180 mcg).

Placebo Spiromaxdrug

Placebo Spiromax is an inhalation-driven, multi-dose dry powder inhaler (DPI) delivering placebo to match the experimental drug. Participants received one dose of two inhalations.