Non-Inferiority,Combination Formoterol/FluticasonexAlenia®Formoterol/Budesonide for Asthma in Brazil (FORASMA)
Moderate Asthma
About this trial
This is an interventional treatment trial for Moderate Asthma
Eligibility Criteria
Inclusion Criteria: Patients of both sexes who meet all of the following criteria will be included in the study: Signature of the Informed Consent Term (ICF) for people over 18 years and, when applicable, signature of the Informed Assent Form (IAF) by the participant under 18 years of age and the ICF by the representative before carrying out any study procedure. Age ≥ 12 years. History of recurrent symptoms suggestive of asthma (cough, wheezing, shortness of breath, and/or chest tightness). Previous medical diagnosis of asthma. Exclusion Criteria: Patients who meet at least one of the following criteria will be excluded from the study: Occurrence of moderate to serious asthma exacerbation within 90 days prior to initiation of study treatment. Presence of acute or chronic symptomatic respiratory tract infection. Body mass index (BMI) ≥ 38 kg/m2. Use of long-acting anticholinergic drug (LAMA) in the last six (06) months.
Sites / Locations
- Eurofarma Laboratorios S.A
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Formoterol 6 mcg/fluticasone 125 mcg
Alenia® 6 mcg/200 mcg
Formoterol 6 mcg/fluticasone 125 mcg Eurofarma.
Alenia® 6 mcg/200 mcg.