Trials / Completed
CompletedNCT01202097
A Non- Inferiority Comparative Study Between Seretide® and Salmeterol/Fluticasone Eurofarma in Patients with Asthma
A PHASE III, RANDOMIZED, OPEN-LABEL, NON-INFERIORITY COMPARATIVE STUDY BETWEEN SERETIDE® 50/250 ΜG and SALMETEROL/FLUTICASONE SINGLE INHALATION CAPSULE 50/250 ΜG EUROFARMA in PATIENTS with ASTHMA
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 334 (actual)
- Sponsor
- Eurofarma Laboratorios S.A. · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective will be to compare the formulations regarding their impact on the pulmonary function of persistent asthma patients and the secondary objective will be the clinical control of the disease's symptoms.
Detailed description
The primary objective will be to compare the formulations regarding their impact on the pulmonary function of persistent asthma patients and the secondary objective will be the clinical control of the disease's symptoms. Primary endpoint: Forced expiratory volume in 1 second (FEV1) at the final visit. Secondary endpoints: Expiratory Flow Peak (EFP), symptoms score, FEV1 throughout the study, use of rescue medication, compliance with inhaler use, inhaler acceptance and preference, and frequency of the observed adverse events.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Salmeterol/Fluticasone | |
| DRUG | Seretide |
Timeline
- Start date
- 2011-08-01
- Completion
- 2012-05-01
- First posted
- 2010-09-15
- Last updated
- 2025-03-31
Locations
6 sites across 1 country: Brazil
Source: ClinicalTrials.gov record NCT01202097. Inclusion in this directory is not an endorsement.