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

A Phase III, Randomized, Open-Label, Non-Inferiority Comparative Study Between Foraseq Inhalation Capsules 12/200 Μg and Formoterol/ Budesonide Inhalation Capsules 12/200 Μg Eurofarma in Patients with Asthma

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.

Study Overview

• Status: Completed
• Conditions: ASTHMA
• Intervention / Treatment: Drug: Formoterol/Budesonide; Drug: Foraseq

Detailed Description

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. This is a non-inferiority study, which hypothesis is that there is no difference on the pulmonary function measure between the groups studied at its end. Therefore, the study primary endpoint will be the forced expiratory volume in 1 second (FEV1) at the final visit (FV) at each study arm.

This study secondary objective is to compare the impact on the clinical control of two products containing budesonide and formoterol as individual capsules with inhalation powder in subjects with persistent asthma.

The secondary endpoints considered for this study are:

• Score of asthma control questionnaire (ACQ-7) 34 at the end of the study ;
• Peak of expiratory flow (PEF) throughout the study;
• Symptoms score at the end of the study;
• FEV1 throughout the study;
• Treatment safety, including serum cortisol dosage;
• Frequency of observed adverse events.

Some eligibility criteria:

• Current use of inhaled corticosteroids (equivalent to beclometasone dipropionate 1000µg) associated or not to long-acting β2-adrenergics and relief medication (salbutamol or equivalent);
• 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;

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 05437 010
      • Centro de Pesquisa Clínica Stelmach

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Formoterol/Budesonide	Drug: Formoterol/Budesonide; 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.
Active Comparator: Foraseq	Drug: Foraseq; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Only one Score of asthma control questionnaire (ACQ-7) 34 at the end of the study.	4 months

Collaborators and Investigators

• Sponsor: Eurofarma Laboratorios S.A.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: October 23, 2009
• First Submitted That Met QC Criteria: October 23, 2009
• First Posted (Estimated): October 26, 2009

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Autonomic Agents; Peripheral Nervous System Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neurotransmitter Agents; Adrenergic Agonists; Adrenergic Agents; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Formoterol Fumarate; Budesonide
• Other Study ID Numbers: EF-091