CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 317 enrolled
Drug / intervention
Albuterol Spiromax®drug
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/NCT01857323
NCT01857323Phase 3Completed
CompareCT.gov

A Prospective, Open-Label Assessment of the Albuterol Spiromax® DPI Integrated Dose Counter

Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted May 20, 2013·Updated Jun 8, 2015

In Brief

A Phase 3 clinical trial evaluating Albuterol Spiromax® for Asthma and Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 317 participants across 30 sites.

Detailed Summary

This is a prospective, open-label, multicenter Phase 3 study evaluating the performance of the Albuterol Spiromax dose counter in patients with a diagnosis of asthma and/or COPD. The purpose of this study is to evaluate the functionality, reliability, and accuracy of the Albuterol Spiromax inhaler integrated dose counter in a clinical setting.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma, Chronic Obstructive Pulmonary Disease (COPD)
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 20, 2013
Enrollment StartMay 1, 2013
Primary CompletionAug 1, 2013
Study CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 13.1 years ago

Interventions

Albuterol Spiromax®drug

Albuterol Spiromax delivers 90 mcg of albuterol base from the mouthpiece per triggered dose. Participants took doses of 2 inhalations each twice a day (morning and evening) for a total daily dose of 360 mcg. The first 45 enrolled participants constituted a subgroup who were dosed for 35 days, while most participants were dosed for 50 days.