Last updated 2 years ago
Efficacy and Safety of Flamboyant 125/12 Association in the Treatment of Adults With Moderate Asthma
134 patients around the world
Available in Brazil
EMS
3Research sites
134Patients around the world
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;Participants aged 18 years or more;Diagnosis of uncontrolled moderate asthma;Participants with Forced expiratory volume in 1 second (FEV1) > 60% of predicted;
- Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;Known hypersensitivity to the formula components used during the clinical trial;History of alcohol and/or substance abuse within 12 months prior to Screening Visit.Current smoking or smoking history equivalent to "10 pack years"Participants with untreated oral candidiasis;Pulmonary disease history (e.g., chronic obstructive pulmonary disease [COPD], cystic fibrosis, bronchiectasis, tuberculosis);Participants with a history of acute asthma exacerbation, respiratory tract infection or hospitalization for asthma in the last 4 weeks;Known HIV-positive status or active hepatitis B or C virus test resultParticipants with current evidence or history of uncontrolled coronary artery disease, congestive heart failure, myocardial infarction or cardiac arrhythmia;Participants with current medical history of cancer and/or cancer treatment in the last 5 years;Participants using medications that would have an effect on bronchospasm and / or lung function.
Sites
Insight Centro de Pesquisas
Recruiting
Instituto Moléstias Cardiovasculares Tatui
Recruiting
CPClin – Centro de Pesquisas Clinicas LTDA
Recruiting
SponsorEMS
Study typeInterventional
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT04191434
