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

NCT02181335 ↗

Phase 3 Completed 684 enrolled Boehringer Ingelheim
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

EvaluationDrugModalityDoseRoute
Subject Budesonide Small molecule 100 ug Inhaled
Subject Budesonide Small molecule 200 ug Inhaled

Indications