A Non- Inferiority Comparative Study Between Seretide® and Salmeterol/Fluticasone Eurofarma in Patients With Asthma (CAINAS SF)
This study has been completed.
Sponsor:
Eurofarma Laboratorios S.A.
Information provided by:
Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier:
NCT01202097
First received: September 14, 2010
Last updated: May 4, 2012
Last verified: September 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Salmeterol/Fluticasone Drug: Seretide |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Eurofarma Laboratorios S.A.:
Primary Outcome Measures:
- Forced expiratory volume in 1 second (FEV1) at the final visit.
Secondary Outcome Measures:
- Expiratory Flow Peak (EFP)
| Estimated Enrollment: | 334 |
| Study Start Date: | August 2011 |
| Study Completion Date: | May 2012 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Salmeterol/Fluticasone | Drug: Salmeterol/Fluticasone |
| Active Comparator: Seretide | Drug: Seretide |
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.
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Sign the ICF
- ≥ 12 years old
- Have a persistent asthma diagnosis, as per GINA classification,18 with symptoms for at least 6 months and clinically stable for at least 1 month with the ACQ-7 test (please see Appendix C) ≤ 3.0
- Current use of inhaled corticosteroid (up to 1000 µg of beclomethasone dipropionate) whether combined or not with long-term β2-adrenergics and relief medication (salbutamol or equivalent)
- Initial FEV1 of at least 40% of the normal value expected
- Blood cortisol evaluation within the normal limits.
Exclusion Criteria:
- Use of oral or parenteral corticosteroid within the last 3 previous months to the study
- Hospitalization needed due to asthma within the last 3 previous months to the study
- Active smokers, defined as the consumption of cigarettes, pipes, cigars or any other form of smoking in any amount within the last 3 months
- Presence of severe co-morbidities, such as cardiovascular, renal, liver, neurological, neoplastic, hematological, infectious, dermatological, neurological or psychiatric disease or chronic respiratory disease other than asthma
- Recent (<6 months) or expected participation during this study in other clinical trials involving drugs of any nature or in studies consisting of any - Intolerance or allergy to any component of the drugs evaluated in the study
- Pregnant or lactating women
- Chronic use of routine β-blockers, orally or intravenously, including ophthalmic solutions.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01202097
Locations
| Brazil | |
| Hospital de Clinicas UFPR | |
| Curitiba, PR, Brazil | |
| Centro de Referencia em Enfermidades Respiratoria e Alergica | |
| Salvador, BA, Brazil | |
| Clinica de Alergia Martti Antila | |
| Sorocaba, SP, Brazil | |
| Stelmach Pesquisa Clinica | |
| São Paulo, Brazil | |
| IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada | |
| São Paulo, Brazil | |
| Centro de Estudos de Pneumologia FMABC | |
| São Paulo, Brazil | |
Sponsors and Collaborators
Eurofarma Laboratorios S.A.
More Information
No publications provided
| Responsible Party: | Máyra Gimenez Solá Zambrana, Eurofarma Laboratorios Ltda |
| ClinicalTrials.gov Identifier: | NCT01202097 History of Changes |
| Other Study ID Numbers: | EF113 |
| Study First Received: | September 14, 2010 |
| Last Updated: | May 4, 2012 |
| Health Authority: | Brazil: Ethics Committee Brazil: National Health Surveillance Agency |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Salmeterol Fluticasone Fluticasone, salmeterol drug combination Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents Glucocorticoids |
ClinicalTrials.gov processed this record on May 16, 2013