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NCT04191434 | Not yet recruiting | Asthma


Efficacy and Safety of Flamboyant 125/12 Association in the Treatment of Adults With Moderate Asthma
Sponsor:

EMS

Brief Summary:

The purpose of this study is to evaluate the efficacy and safety of Flamboyant 125/12 association in adults with asthma.

Condition or disease

Asthma

Intervention/treatment

Flamboyant 125/12

Budesonide/formoterol 200/6

Flamboyant 125/12 Placebo

Budesonide/formoterol 200/6 placebo

Phase

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 125/12 Association in the Treatment of Adults With Moderate Asthma .
Actual Study Start Date : September 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : November 2022
Arm Intervention/treatment

Experimental: FLAMBOYANT 125/12

The study is double-dummy. Thus, the participant must inhale 2 (two) capsules twice a day (12/12h), as follow: 1 Flamboyant 125/12 capsule 1 Budesonide/formoterol 200/6 Placebo capsule.

Drug: Flamboyant 125/12

Other: Budesonide/formoterol 200/6 placebo

Active Comparator: Budesonide/formoterol 200/6

The study is double-dummy. Thus, the participant must inhale 2 (two) capsules twice a day (12/12h), as follow: 1 Budesonide/formoterol 200/6 capsule 1 Flamboyant 125/12 Placebo capsule.

Drug: Budesonide/formoterol 200/6

Other: Flamboyant 125/12 Placebo

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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 moderate 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 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.

Efficacy and Safety of Flamboyant 125/12 Association in the Treatment of Adults With Moderate Asthma

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Efficacy and Safety of Flamboyant 125/12 Association in the Treatment of Adults With Moderate Asthma

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