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

Study Overview
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Brief Summary
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Double-blind, multinational, multicentre, randomized, 2-arm parallel-group study

Detailed Description
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To compare efficacy of Foster as maintenance therapy plus additional inhalations as reliever with Foster as maintenance plus salbutamol as reliever in asthmatics

Official Title
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48-week,Multinational,Randomized,Double-blind,2-parallel Groups,Comparing the Efficacy of Foster for Maintenance and Reliever Versus Fixed-dose Foster for Maintenance Plus Salbutamol as Reliever in Asthmatics >=18 Years of Age

Conditions
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Asthma

Intervention / Treatment
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* Drug: Ventolin
* Drug: beclometasone /formoterol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Beclometasone/formoterol (100/6 µg)<br>Foster : fixed combination of BDP extrafine 100 µg plus formoterol fumarate 6 µg administered via a pMDI standard actuator | Drug: beclometasone /formoterol<br>* BDP 100µg/FF 6µg, 1 inhalation bid<br>* Other names: Foster;|
| Active Comparator: salbutamol<br>Ventolin : salbutamol sulphate 100 µg per metered dose | Drug: Ventolin<br>* Ventolin : salbutamol sulfate 100µg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first severe asthma exacerbation |  | At each clinic visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of severe asthma exacerbations Number of hospitalization Asthma symptoms Rescue medication LFTs |  | At each clinic visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Maintenance and Reliever Treatments