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

This study has been completed.
Sponsor:
Information provided by:
Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier:
NCT01001364
First received: October 23, 2009
Last updated: June 27, 2011
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
ASTHMA
Drug: Formoterol/Budesonide
Drug: Foraseq
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Eurofarma Laboratorios S.A.:

Primary Outcome Measures:
  • The study primary endpoint will be the forced expiratory volume in 1 second (FEV1) at the final visit (FV) at each study arm. [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Only one Score of asthma control questionnaire (ACQ-7) 34 at the end of the study. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Enrollment: 88
Study Start Date: February 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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;
  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01001364

Locations
Brazil
Centro de Pesquisa Clínica Stelmach
São Paulo, SP, Brazil, 05437 010
Sponsors and Collaborators
Eurofarma Laboratorios S.A.
  More Information

No publications provided

Responsible Party: Ana Lucia Koff Milan, Eurofarma Laboratorios LTDA
ClinicalTrials.gov Identifier: NCT01001364     History of Changes
Other Study ID Numbers: EF-091
Study First Received: October 23, 2009
Last Updated: June 27, 2011
Health Authority: Brazil: Ethics Committee
Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Respiratory Aspiration
Asthma
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Bronchial Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Formoterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists

ClinicalTrials.gov processed this record on April 17, 2014