EMS
The purpose of this study is to evaluate the efficacy and safety of Flamboyant 200/12 association in adults with asthma.
Asthma
Flamboyant 200/12
Budesonide / Formoterol 400/12
Flamboyant 200/12 Placebo
Budesonide / Formoterol 400/12 Placebo
Phase 3
Study Type : | Interventional |
Estimated Enrollment : | 134 participants |
Masking : | Double |
Masking Description : | Double-blind and double-dummy |
Primary Purpose : | Treatment |
Official Title : | 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 . |
Actual Study Start Date : | July 22, 2022 |
Estimated Primary Completion Date : | July 2023 |
Estimated Study Completion Date : | October 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: FLAMBOYANT 200/12 The study is double-dummy. Thus, the participant must inhale 2 (two) capsules twice a day (12/12h), as follow: 1 Flamboyant 200/12 capsule 1 Budesonide/formoterol Placebo capsule. |
Drug: Flamboyant 200/12 Other: Budesonide / Formoterol 400/12 Placebo |
Active Comparator: Budesonide/formoterol 400/12 The study is double-dummy. Thus, the participant must inhale 2 (two) capsules twice a day (12/12h), as follow: 1 Budesonide/formoterol 400/12 capsule 1 Flamboyant 200/12 Placebo capsule. |
Drug: Budesonide / Formoterol 400/12 Other: Flamboyant 200/12 Placebo |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
BMI Tatuí
Tatuí, São Paulo, Brazil,