Multicenter, Randomized, Double-blind, Double-dummy, National, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Flamboyant 200/12 Association in the Treatment of Adults With Severe Asthma .

NCT04191447 Phase 3 UNKNOWN

The purpose of this study is to evaluate the efficacy and safety of Flamboyant 200/12 association in adults with asthma.

Details

Lead sponsor	EMS
Phase	Phase 3
Status	UNKNOWN
Enrolment	134
Start date	2022-07-22
Completion	2023-10

Conditions

• Asthma

Interventions

• Flamboyant 200/12
• Budesonide / Formoterol 400/12
• Flamboyant 200/12 Placebo
• Budesonide / Formoterol 400/12 Placebo

Primary outcomes

• Change from baseline in Forced expiratory volume in 1 second (FEV1), obtained through espirometry. — 12 weeks

Countries

Brazil