CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,850 enrolled
Drug / intervention
budesonide/formoterol 'as needed' + budesonide placebo bid +2 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/NCT02149199
NCT02149199Phase 3Completed
CompareCT.gov

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

AstraZeneca·interventional·Posted May 29, 2014·Updated Nov 15, 2019

In Brief

A Phase 3 clinical trial evaluating budesonide/formoterol 'as needed' + budesonide placebo bid, terbutaline 'as needed' + placebo budesonide bid, and 1 other intervention for Asthma. Completed, enrolled 3,850 participants across 255 sites in 18 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: 1) terbutaline Turbuhaler® 'as needed' and with 2) Pulmicort (budesonide) Turbuhaler® twice daily plus terbutaline Turbuhaler® 'as needed'.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesAustralia, Brazil, Bulgaria, Canada, Chile, China, Hungary, Mexico, Peru, Philippines, Poland, Romania, Russia, South Africa, South Korea, Ukraine, United Kingdom, Vietnam
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 29, 2014
Enrollment StartJul 7, 2014
Primary CompletionAug 2, 2017
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 12.1 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

terbutaline 'as needed' + placebo budesonide biddrug

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

budesonide 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