Efficacy and Tolerability of Beclomethasone Dipropionate/Formoterol Single Inhaler in Patients With Mild to Moderate Persistent Asthma

Study Overview
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Brief Summary
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Efficacy and tolerability of the fixed combination Beclomethasone Dipropionate /Formoterol in patients with mild to moderate persistent asthma.

Detailed Description
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The purpose of this study is to evaluate the efficacy and tolerability of Beclomethasone Dipropionate/Formoterol single inhaler in a twice daily regimen in patients with mild to moderate persistent asthma. Patients are randomised to receive either Beclomethasone Dipropionate/ formoterol single inhaler (total daily dose : BDP/FF 400/24 µg) or Beclomethasone CFC (total daily dose : BDP 1000 µg) during 12 weeks of treatment.

Official Title
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A 12-week Phase III Study to Evaluate the Efficacy and Tolerability of Beclomethasone Dipropionate/Formoterol Single Inhaler HFA 134a-pMDI in Adult Patients With Mild to Moderate Persistent Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of mild to moderate persistent asthma (according to GINA 2003 guidelines) FEV1 > or = 60% and < or = 85% of predicted normal values Patients free of LABA at least for one month before screening and already treated for at least two months with ICS and experiencing (i)a daily use of SABAs between 1 and 4 puffs, (ii) and/or clinical symptoms three times in the week prior to inclusion A documented positive response to the reversibility test Exclusion Criteria: Pregnant or lactating females or women of childbearing potential without any efficient contraception Heavy smokers defined as smoking for > 10 pack years Evidence of asthma exacerbation causing an hospitalisation or requiring treatment with oral/parenteral corticosteroids or evidence of symptomatic airways infection in the 4 weeks prior to inclusion (3 months for slow-release corticosteroids) Seasonal asthma or asthma occurring only during episodic exposure to an allergen or occupational chemical sensitizer Clinical significant or unstable concomitant diseases, including clinically significant laboratory abnormalities Evidence of asthma worsening during the week preceding randomisation (e.g PEF variability > or = 30% during 2 consecutive days, SABA use > 8 puffs/day during 2 consecutive days, nocturnal awakenings due to asthma symptoms during 3 consecutive days

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: CHF 1535 pMDI<br>CHF 1535 HFA pMDI aerosol (100 µg/unit dose of beclomethasone dipropionate plus 6 µg of formoterol/unit dose | Drug: Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI<br>* Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI<br>|
| Active Comparator: BDP pMDI<br>Beclomethasone dipropionate-CFC pMDI, 250 µg/unit dose | Drug: Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI<br>* Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-dose morning PEF |  | At the end of treatment after 3 month of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-dose FEV1 - Other spirometric parameters - |  | Every 6 weeks | 
| Percentage of night and/or days free of clinical symptoms |  | End of treatment after 3 month of treatment | 
| Morning and evening asthma clinical symptom scores |  | End of treatment after 3 month of treatment | 
| Use of rescue short-acting b2-agonists |  | End of treatment after 3 month of treatment | 
| Asthma exacerbations |  | Every 6 weeks | 
| Safety and Tolerability |  | Every 6 weeks |