A Comparative Study Between Foraseq and Formoterol/Budesonide Inhalation Capsules in Patients with Asthma

NCT01001364 | Completed Phase 3 DMC

• 1 other identifier: EF-091
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

This study primary objective is to compare the impact of two products containing budesonide and formoterol as individual capsules with inhalation powder for the pulmonary function of subjects with persistent asthma.

Conditions

ASTHMA

Outcome Measures

Primary Outcomes (1)

• The study primary endpoint will be the forced expiratory volume in 1 second (FEV1) at the final visit (FV) at each study arm.

  4 months

Secondary Outcomes (1)

• Only one Score of asthma control questionnaire (ACQ-7) 34 at the end of the study.

  4 months

Study Arms (2)

Formoterol/Budesonide

EXPERIMENTAL

Drug: Formoterol/Budesonide

Foraseq

ACTIVE COMPARATOR

Drug: Foraseq

Interventions

Formoterol/Budesonide DRUG

formoterol will be administered at the 12 µg dosage, twice a day, and budesonide will be administered at the 200 µg dose, also twice a day for 12 weeks.

Formoterol/Budesonide

Foraseq DRUG

formoterol will be administered at the 12 µg dosage, twice a day, and budesonide will be administered at the 200 µg dose, also twice a day for 12 weeks.

Foraseq

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign ICF (see Attachment A);
• Age ≥12 years old
• Diagnosis of mild to moderate persistent asthma, as per the ARIA classification, 35 with symptoms for at least 6 months, clinically stable for at least 1 month with ACQ-7 test34 (see Attachment D) \< 3.0;
• Current use of inhaled corticosteroids (equivalent to beclometasone dipropionate 1000µg) associated or not to long-acting β2-adrenergics and relief medication (salbutamol or equivalent);
• Initial FEV1 of at least 50% of the normal value estimated.
• Serum cortisol evaluation within the normal values

You may not qualify if:

• Use of oral or parenteral corticosteroids within the last 3 months;
• Need of hospitalization due to asthma within the last 3 months;
• Active tabagism, defined as the use of cigarettes, pipe, cigar or any other type in any amount within the last 3 months;
• Severe co-morbidity, such as cardiovascular, renal, liver, neurologic, neoplastic, blood, infectious, dermatologic, neurologic, psychiatric or chronic respiratory diseases, other than asthma;
• Recent participation (\<6 months) or planned participation, during this study, on other clinical trials involving drugs of any nature or under studies of any type of intervention for the asthma treatment;
• Intolerance or allergy to any of the compounds of the drugs evaluated on the study;
• Pregnancy or lactation;
• Chronic use of routine oral or intravenous β-blocker drugs, even ophthalmic solutions.

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

Study Sites (1)

Centro de Pesquisa Clínica Stelmach

São Paulo, São Paulo, 05437 010, Brazil

Location

MeSH Terms

Conditions

Asthma

Interventions

Formoterol Fumarate; Budesonide

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2009
• First Posted: October 26, 2009
• Study Start: February 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: March 19, 2025

Record last verified: 2025-03

Locations

BR (1)