CompletedPhase 3

A Multicenter, Randomized, Parallel, Two-period, Non-inferiority Study of EurofarmavsAlenia in Asthma and COPD Treatment

Brazil472 participantsStarted 2023-04-19

Plain-language summary

A phase III study, multicenter, randomized, parallel, open, two-period, comparative non-inferiority of Eurofarma versus Alenia® in the treatment of moderate to severe persistent asthma with and without obstructive pulmonary disease (COPD). ⚠️study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).

Who can participate

Age range12 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥ 12 years * Presence of moderate to severe persistent asthma according to Global Initiative for Asthma (GINA) 1 criteria for at least 1 year, clinically stable (controlled) for at least 30 days. Exclusion Criteria: * Occurrence of asthma exacerbation within 30 days prior to initiation of study treatment. * Presence of acute or chronic symptomatic airway infection.

What they're measuring

FEV1

Timeframe: 24 weeks

Trial details

NCT IDNCT04233190

SponsorEurofarma Laboratorios S.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-28

View on ClinicalTrials.gov More Asthma Copd trials