At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 4,215 enrolled

Drug / intervention

budesonide/formoterol 'as needed' + budesonide placebo bid +1 moredrug

Likely dose

budesonide/formoterol 'as needed' + budesonide placebo bid 4.5 μgfrom 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/NCT02224157

NCT02224157Phase 3Completed

Compare CT.gov

A Clinical Study Comparing Symbicort 'as Needed' With Pulmicort Twice Daily Plus Terbutaline 'as Needed' in Adult and Adolescent Patients With Asthma

AstraZeneca·interventional·Posted Aug 25, 2014·Updated Nov 25, 2019

In Brief

A Phase 3 clinical trial evaluating budesonide/formoterol 'as needed' + budesonide placebo bid and budesonode bid + terbutaline 'as needed' for Asthma. Completed, enrolled 4,215 participants across 340 sites in 25 countries.

Detailed Summary

The purpose of this study is to test if Symbicort (budesonide/formoterol) Turbuhaler is effective in treating asthma when used 'as needed' in patients with milder asthma. The efficacy of Symbicort 'as needed' will be compared with Pulmicort (budesonide) Turbuhaler twice daily plus terbutaline Turbuhaler 'as needed'

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAsthma

CountriesAustralia, Brazil, Bulgaria, Chile, Colombia, Czechia, France, Germany, Hungary, Mexico, New Zealand, Peru, Philippines, Poland, Romania, Russia, Saudi Arabia, Slovakia, South Africa, South Korea, Spain, Sweden, Thailand, Ukraine, Vietnam

Collaborators--

Timeline

Phase 3CompletedFinished

201520162017201820192020202120222023202420252026

First PostedAug 2014

Enrollment StartNov 2014

Primary CompletionAug 2017

TodayJul 2026

First PostedAug 25, 2014

Enrollment StartNov 28, 2014

Primary CompletionAug 16, 2017

TodayJul 2, 2026

Enrollment to primary: 2.7 yearsPosted 11.9 years ago

Interventions

budesonide/formoterol 'as needed' + budesonide placebo biddrug

Symbicort (budesonide/ formoterol) 160/4.5 μg powder for inhalation 'as needed' plus Pulmicort placebo 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening), 52-week treatment

budesonode bid + terbutaline 'as needed'drug

Pulmicort (budesonide) 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening) plus terbutaline 0.4 mg powder for inhalation 'as needed', 52-week treatment