Back to resultsA Study Comparative of Formoterol/Fluticasone Foraseq® and Fluticasone in Asthma Patients
Primary Purpose
Asthma
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Formoterol/Fluticasone
Foraseq®
Fluticasone
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
Inclusion Criteria:
- Sign the ICF
- Age ≥ 12 years
- Persistent asthma diagnosis, as per the GINA classification (www.ginasthma.com),18 with symptoms for at least 6 months and clinically stable for at least 1 month, with the ACQ-745 test (see Appendix C) ≤ 3.0
- Current use of inhaled corticosteroid (beclomethasone dipropionate dose of up to 1000 µg), associated or not with long-term β2-adrenergic agents and breakthrough medication (salbutamol or equivalent)
- Initial FEV1 of at least 40% of the predicted normal value
- Serum cortisol assessment within normal values.
Exclusion Criteria:
- Use of oral or parenteral corticosteroid within the 3 months prior to study beginning
- Requirement of admission due to asthma within the 3 months prior to study beginning
- Presence of active smoking, defined as the use of cigarette, pipe, cigar or any form of smoking at any amount within the last 3 months
- Presence of severe co-morbidities, such as cardiovascular, renal, liver, neurological, neoplastic, hematological, infectious, dermatological, neurological, psychiatric or chronic respiratory disease other than asthma
- Recent (< 6 months) or predicted participation during this study in other clinical studies involving drugs of any nature or in studies of any form of intervention for treating asthma
- Intolerance or allergy to any of the components of the drugs assessed in the study
- Pregnancy or lactation
- Chronic use of β-blocker medications, per routine oral or intravenous route, or also as ophthalmic solutions
Sites / Locations
- IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Formoterol/Fluticasone Eurofarma
Foraseq®
Fluticasone
Arm Description
formoterol + fluticasone (12/250 mcg) twice a day per 12 weeks
formoterol + budedonide (12/400 mcg) twice a day per 12 weeks
fluticasone (500 mcg) twice a day per 12 weeks
Outcomes
Primary Outcome Measures
Forced expiratory volume in 1 second (FEV1) at final visit.
Secondary Outcome Measures
Peak expiratory flow (PEF)
Full Information
NCT ID
NCT01202084
First Posted
September 14, 2010
Last Updated
June 17, 2015
Sponsor
Eurofarma Laboratorios S.A.
1. Study Identification
Unique Protocol Identification Number
NCT01202084
Brief Title
A Study Comparative of Formoterol/Fluticasone Foraseq® and Fluticasone in Asthma Patients
Official Title
A Phase III, Randomized, Open-label, Non-inferiority Study Comparative of Formoterol/Fluticasone Eurofarma 12/250 µg, Foraseq® 12/400 µg and Fluticasone 500 µg in Asthma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eurofarma Laboratorios S.A.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective will be to compare the impact of the study formulations on pulmonary function in persistent asthma carriers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
222 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Formoterol/Fluticasone Eurofarma
Arm Type
Experimental
Arm Description
formoterol + fluticasone (12/250 mcg) twice a day per 12 weeks
Arm Title
Foraseq®
Arm Type
Active Comparator
Arm Description
formoterol + budedonide (12/400 mcg) twice a day per 12 weeks
Arm Title
Fluticasone
Arm Type
Active Comparator
Arm Description
fluticasone (500 mcg) twice a day per 12 weeks
Intervention Type
Drug
Intervention Name(s)
Formoterol/Fluticasone
Intervention Type
Drug
Intervention Name(s)
Foraseq®
Intervention Type
Drug
Intervention Name(s)
Fluticasone
Primary Outcome Measure Information:
Title
Forced expiratory volume in 1 second (FEV1) at final visit.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Peak expiratory flow (PEF)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Sign the ICF
Age ≥ 12 years
Persistent asthma diagnosis, as per the GINA classification (www.ginasthma.com),18 with symptoms for at least 6 months and clinically stable for at least 1 month, with the ACQ-745 test (see Appendix C) ≤ 3.0
Current use of inhaled corticosteroid (beclomethasone dipropionate dose of up to 1000 µg), associated or not with long-term β2-adrenergic agents and breakthrough medication (salbutamol or equivalent)
Initial FEV1 of at least 40% of the predicted normal value
Serum cortisol assessment within normal values.
Exclusion Criteria:
Use of oral or parenteral corticosteroid within the 3 months prior to study beginning
Requirement of admission due to asthma within the 3 months prior to study beginning
Presence of active smoking, defined as the use of cigarette, pipe, cigar or any form of smoking at any amount within the last 3 months
Presence of severe co-morbidities, such as cardiovascular, renal, liver, neurological, neoplastic, hematological, infectious, dermatological, neurological, psychiatric or chronic respiratory disease other than asthma
Recent (< 6 months) or predicted participation during this study in other clinical studies involving drugs of any nature or in studies of any form of intervention for treating asthma
Intolerance or allergy to any of the components of the drugs assessed in the study
Pregnancy or lactation
Chronic use of β-blocker medications, per routine oral or intravenous route, or also as ophthalmic solutions
Facility Information:
Facility Name
IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada
City
São Paulo
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
A Study Comparative of Formoterol/Fluticasone Foraseq® and Fluticasone in Asthma Patients
We'll reach out to this number within 24 hrs