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

NCT04233190 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 472

Last updated 2025-02-14

No results posted yet for this study

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).

Conditions

  • Asthma Copd

Interventions

DRUG

Alenia® 12mcg + 400mcg / Alenia® 6mcg + 200mcg

one inhalation, twice daily

Sponsors & Collaborators

  • Eurofarma Laboratorios S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-19
Primary Completion
2024-10-28
Completion
2024-10-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04233190 on ClinicalTrials.gov