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

NCT ID: NCT01202084

Last Updated: 2015-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 222 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-11-30

Brief Summary

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

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Formoterol/Fluticasone Eurofarma

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

Group Type: EXPERIMENTAL

Formoterol/Fluticasone

Intervention Type: DRUG

Foraseq®

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

Group Type: ACTIVE_COMPARATOR

Foraseq®

Intervention Type: DRUG

Fluticasone

fluticasone (500 mcg) twice a day per 12 weeks

Group Type: ACTIVE_COMPARATOR

Fluticasone

Intervention Type: DRUG

Interventions

Formoterol/Fluticasone

Intervention Type: DRUG

Foraseq®

Intervention Type: DRUG

Fluticasone

Intervention Type: DRUG

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eurofarma Laboratorios S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada

São Paulo, , Brazil

Countries

Brazil

References

Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.

Reference Type: DERIVED

PMID: 36472162 (View on PubMed)

Other Identifiers

CAINAS FF

Identifier Type: -

Identifier Source: secondary_id

EF 065

Identifier Type: -

Identifier Source: org_study_id