CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 605 enrolled
Drug / intervention
Budesonide/Formoterol SPIROMAX® +3 moredrug
Likely dose
Not stated in 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/NCT01803555
NCT01803555Phase 3Completed
CompareCT.gov

A 12-Week Efficacy and Safety Evaluation of Budesonide/Formoterol SPIROMAX(R) 160/4.5 mcg Inhalation Powder Versus SYMBICORT(R) TURBOHALER(R) 200/6 mcg in Adult and Adolescent Patients With Persistent Asthma

Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Mar 4, 2013·Updated Dec 8, 2023

In Brief

A Phase 3 clinical trial evaluating Budesonide/Formoterol SPIROMAX®, SYMBICORT® TURBOHALER®, and 2 other interventions for Asthma. Completed, enrolled 605 participants across 114 sites in 16 countries.

Detailed Summary

The primary objective of the study is to establish whether budesonide/formoterol fumarate dihydrate (BF) Spiromax 160/4.5 micrograms (mcg) is as effective as Symbicort Turbohaler 200/6 mcg administered twice daily in participants with persistent asthma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesAustria, Belgium, Czechia, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Russia, Spain, Sweden, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 4, 2013
Enrollment StartJul 4, 2013
Primary CompletionMar 20, 2014
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 13.3 years ago

Interventions

Budesonide/Formoterol SPIROMAX®drug

BF Spiromax will be administered per dose and schedule specified in the arm.

SYMBICORT® TURBOHALER®drug

Symbicort Turbohaler will be administered per dose and schedule specified in the arm.

SYMBICORT placebodrug

SYMBICORT placebo multi-dose dry powder inhaler (DPI) identical in appearance to SYMBICORT TURBOHALER will be administered per dose and schedule specified in the arm.

SPIROMAX Placebodrug

SPIROMAX Placebo multi-dose dry powder inhaler (DPI) identical in appearance to BF SPIROMAX will be administered per dose and schedule specified in the arm.