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A Study Comparative of Formoterol/Fluticasone Foraseq® and Fluticasone in Asthma Patients

Sponsor
Eurofarma Laboratorios S.A. (Industry)
Overall Status
Completed
CT.gov ID
NCT01202084
Collaborator
(none)
222
Enrollment
1
Location
3
Arms
10
Duration (Months)
22.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective will be to compare the impact of the study formulations on pulmonary function in persistent asthma carriers.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
222 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Jan 1, 2012
Actual Primary Completion Date :
Nov 1, 2012
Actual Study Completion Date :
Nov 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Formoterol/Fluticasone Eurofarma

formoterol + fluticasone (12/250 mcg) twice a day per 12 weeks

Drug: Formoterol/Fluticasone
Active Comparator: Foraseq®

formoterol + budedonide (12/400 mcg) twice a day per 12 weeks

Drug: Foraseq®
Active Comparator: Fluticasone

fluticasone (500 mcg) twice a day per 12 weeks

Drug: Fluticasone

Outcome Measures

Primary Outcome Measures

  1. Forced expiratory volume in 1 second (FEV1) at final visit. [12 weeks]

Secondary Outcome Measures

  1. Peak expiratory flow (PEF) [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada São Paulo Brazil

Sponsors and Collaborators

  • Eurofarma Laboratorios S.A.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier:
NCT01202084
Other Study ID Numbers:
  • EF 065
  • CAINAS FF
First Posted:
Sep 15, 2010
Last Update Posted:
Jun 18, 2015
Last Verified:
May 1, 2012
Additional relevant MeSH terms:
Asthma
Fluticasone
Xhance
Formoterol Fumarate

Study Results

No Results Posted as of Jun 18, 2015