Trials / Completed
CompletedNCT01803555
Efficacy and Safety Evaluation of Budesonide/Formoterol SPIROMAX® Inhalation Powder Versus SYMBICORT® TURBOHALER®
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 605 (actual)
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc. · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Budesonide/Formoterol SPIROMAX® | BF Spiromax will be administered per dose and schedule specified in the arm. |
| DRUG | SYMBICORT® TURBOHALER® | Symbicort Turbohaler will be administered per dose and schedule specified in the arm. |
| DRUG | SYMBICORT placebo | 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. |
| DRUG | SPIROMAX Placebo | 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. |
Timeline
- Start date
- 2013-07-04
- Primary completion
- 2014-03-20
- Completion
- 2014-03-20
- First posted
- 2013-03-04
- Last updated
- 2023-12-08
- Results posted
- 2023-12-08
Locations
114 sites across 16 countries: Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Russia, Spain, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT01803555. Inclusion in this directory is not an endorsement.