drugset / Trial / NCT02181335
Efficacy and Safety Study Comparing Respimat ® Budesonide With Turbohaler ® Budesonide in Symptomatic Adult Moderate to Severe Asthmatics Requiring Inhaled Corticosteroids and Bronchodilator Therapy
RandomizedParallel-groupDouble-blindTreatment
Summary
To establish that at least one of the two doses of Budesonide, as an ethanolic solution inhaled from the Respimat ® inhaler (100 and 200 mcg, 2 puffs bid) for a 12-week study period in symptomatic moderate to severe asthmatic patients, gives a therapeutic response, which is not inferior to that obtained from the dose of Budesonide inhaled from the Turbohaler ® (200 mcg, 2 puffs bid) and that the safety profile is at least as good
Timeline
- Start
- 1998-10
- Primary completion
- 2001-06
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Budesonide | Small molecule | 100 ug | Inhaled |
| Subject | Budesonide | Small molecule | 200 ug | Inhaled |