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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.
October 23, 2009
October 26, 2009
June 28, 2011
February 2010
April 2011   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01001364 on ClinicalTrials.gov Archive Site
Only one Score of asthma control questionnaire (ACQ-7) 34 at the end of the study. [ Time Frame: 4 months ]
Same as current
Not Provided
Not Provided
 
A Comparative Study Between Foraseq And Formoterol/Budesonide Inhalation Capsules in Patients With Asthma
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.

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;
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
ASTHMA
  • 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.
  • 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.
  • Experimental: Formoterol/Budesonide
    Intervention: Drug: Formoterol/Budesonide
  • Active Comparator: Foraseq
    Intervention: Drug: Foraseq
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
April 2011
April 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01001364
EF-091
Yes
Not Provided
Not Provided
Ana Lucia Koff Milan, Eurofarma Laboratorios LTDA
Eurofarma Laboratorios S.A.
Not Provided
Not Provided
Eurofarma Laboratorios S.A.
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP