A Comparative Study Between Foraseq And Formoterol/Budesonide Inhalation Capsules in Patients With Asthma
Information source: Eurofarma Laboratorios S.A.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: ASTHMA
Intervention: Formoterol/Budesonide (Drug); Foraseq (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Eurofarma Laboratorios S.A.
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The study primary endpoint will be the forced expiratory volume in 1 second (FEV1) at the final visit (FV) at each study arm.
Secondary outcome: Only one Score of asthma control questionnaire (ACQ-7) 34 at the end of the study.
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
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Centro de Pesquisa ClÃnica Stelmach, São Paulo, SP 05437 010, Brazil
Additional Information
Starting date: February 2010
Last updated: June 27, 2011
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