Efficacy and Safety of Flamboyant 200/12 Association in the Treatment of Adults With Severe Asthma

• Status: Not yet recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMS
• Treatments: Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Formoterol Fumarate

Criteria

Inclusion Criteria:

• 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 severe asthma;

• Participants with Forced expiratory volume in 1 second (FEV1) > 60% of predicted;

Exclusion Criteria:

• 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 result

• Participants with current evidence or history of uncontrolled coronary artery disease, congestive heart failure, myocardial infarction or cardiac arrhythmia;

• Participants with a 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.