Trials / Completed
CompletedNCT01167010
A Non-inferiority, Comparative Study Between Foraseq®, Eurofarma´s Formoterol/Budesonide and Alenia® in Asthma
A Phase III, Randomized, Non-inferiority, Open-label, Comparative Study Between Foraseq® Inhalation Capsules, Eurofarma's Single Formoterol / Budesonide Inhalation Capsule and Single Alenia® Inhalation Capsule in Asthmatic Patients
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 552 (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 Eurofarma and Alenia formulations regarding their impact on the pulmonary function of mild to moderate persistent asthma patients and the secondary objective will be to compare the three study formulations regarding the clinical control of the symptoms and the patients' compliance to the treatment.
Detailed description
The primary objective will be to compare the Eurofarma and Alenia formulations regarding their impact on the pulmonary function of mild to moderate persistent asthma patients and the secondary objective will be to compare the three study formulations regarding the clinical control of the symptoms and the patients' compliance to the treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Formoterol/Budesonide | formoterol and budesonide will be administered at the 12/400 µg dosage, twice a da for 12 weeks. |
| DRUG | Foraseq | foraseq will be administered at the 12/400 µg dosage, twice a da for 12 weeks. |
| DRUG | Alenia | Alenia will be administered at the 12/400 µg dosage, twice a da for 12 weeks. |
Timeline
- Start date
- 2011-04-01
- Primary completion
- 2011-08-01
- Completion
- 2012-02-01
- First posted
- 2010-07-21
- Last updated
- 2025-05-01
- Results posted
- 2025-05-01
Locations
5 sites across 1 country: Brazil
Source: ClinicalTrials.gov record NCT01167010. Inclusion in this directory is not an endorsement.