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”

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 Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2010

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 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;

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Formoterol/Budesonide
• Active Comparator: Foraseq

Primary 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
    Safety Issue?: No

Secondary Measures

• Only one Score of asthma control questionnaire (ACQ-7) 34 at the end of the study.
  • Time Frame: 4 months
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Eurofarma Laboratorios Ltda

Overall Clinical Trial Officials and Contacts

Overall Contact: Rafael Stelmach, M.D. +55 11 3069 5034 rafael.stelmach@incor.usp.br

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01001364

Study ID Number: EF-091

ClinicalTrials.gov Identifier: NCT01001364

Health Authority: Brazil: Ethics Committee