We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01001364
First Posted: October 26, 2009
Last Update Posted: June 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Eurofarma Laboratorios S.A.
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01001364


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

Responsible Party: Ana Lucia Koff Milan, Eurofarma Laboratorios LTDA
ClinicalTrials.gov Identifier: NCT01001364     History of Changes
Other Study ID Numbers: EF-091
First Submitted: October 23, 2009
First Posted: October 26, 2009
Last Update Posted: June 28, 2011
Last Verified: June 2010

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Formoterol Fumarate
Budesonide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists