Study Comparing Foster Efficacy Maintenance and Reliever Versus Foster Maintenance + Salbutamol Reliever in Asthmatics

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Double-blind, multinational, multicentre, randomized, 2-arm parallel-group study

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.
• Treatments: Albuterol; Beclomethasone; Formoterol Fumarate

Criteria

Inclusion Criteria:

• Written signed and dated informed consent obtained.

• Male or female patients aged ≥ 18 years.

• A positive reversibility test

• Patients who experienced at least one severe exacerbation in the 12 months before entry (but not in the last month)

• Using inhaled corticosteroids (ICS) in monotherapy or using ICS in a fixed or free combination with long acting beta2 agonists (LABA) at a constant dose for two months before screening visit

• Not fully controlled asthmatics (which means partly controlled or/and uncontrolled patients according to GINA guidelines 2007) in the last month before screening visit

• Forced expiratory volume in the first second (FEV1) ≥ 60% of predicted for the patient normal value.

• Non smokers or ex-smokers

Exclusion Criteria:

• Pregnant or nursing (lactating) women. Women of child-bearing potential UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/mL or are using one or more of acceptable methods of contraception

• Body Mass Index (BMI) > 34 kg/m2.

• Patient with lower respiratory tract infections affecting the patient's asthma within 30 days of the screening visit.

• Use of systemic steroids in the last month.

• Patients with other lung diseases such as COPD, cystic fibrosis, interstitial lung diseases or any other clinically or functionally significant lung disorder.

• Patients who have an uncontrolled respiratory, haematological, immunologic, renal, neurologic, hepatic, endocrinal or other disease.

• Clinically relevant laboratory abnormalities

• Patients who have an abnormal QTcF interval value

• Intolerance or contra-indication to treatment with beta2-agonists and/or ICS or allergy to any component of the study treatments.

• Patients treated with slow-release corticosteroids in the 3 months prior to screening visit.

• Patients being treated with anti-IgE antibodies.

• Patients treated with LABA or ICS/LABA fixed combination in the 24h before screening visit

• Severe asthma exacerbation in the last month before screening visit