Efficacy and Tolerability of Beclometasone/Formoterol Single Inhaler in Patients With Moderate to Severe Persistent Asthma

Study Overview
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Brief Summary
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Efficacy and tolerability of the fixed combination beclometasone/formoterol in patients with moderate to severe persistent asthma.

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

Official Title
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A 24-week Phase III Study to Evaluate the Efficacy and Tolerability of Beclometasone/Formoterol Single Inhaler HFA 134a-pMDI in Adult Patients With Moderate to Severe Persistent Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: beclomethasone/formoterol (100/6µg) pMDI
* Drug: Beclometasone dipropionate 250 µg/unit dose pMDI
* Drug: Formoterol powder 12 µg/unit dose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of moderate to severe persistent asthma (according to GINA 2002 guidelines) FEV1 > 40% and < 80% of predicted normal post-bronchodilator (and at least 0.7 L absolute value) Patients already treated for at least 2 months with an association of inhaled corticosteroids plus LABA at doses of: 750 - 1000 µg beclomethasone dipropionate or equivalent (ICSs) 24 µg formoterol or 100 µg salmeterol (LABAs) Or patients naïve of LABA already treated for at least 2 months with inhaled corticosteroids (doses as above) associated with a daily use of SABA and/or with clinical symptoms > 3 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. Clinically significant or unstable concomitant diseases, including clinically significant laboratory abnormalities. Patients with an abnormal QTc interval value in the ECG test, defined as > 450 msec in males or > 470 msec in females. Evidence of asthma worsening during the week preceding randomisation (e.g. PEF variability > 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

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: beclometasone /formoterol<br>beclomethasone dipropionate 100 µg plus formoterol 6 µg pMDI | Drug: beclomethasone/formoterol (100/6µg) pMDI<br>* Two puffs b.i.d<br>|
| Active Comparator: Beclomethasone<br>Beclomethasone dipropionate (BecotideTM) 250 µg/unit dose pMDI aerosol via CFC propellant. | Drug: Beclometasone dipropionate 250 µg/unit dose pMDI<br>* 2 inhalations bid<br>* Other names: BecotideTM;|
| Active Comparator: Formoterol powder 12 µg/unit dose<br>Formoterol powder 12 µg/unit dose (Foradil™) | Drug: Formoterol powder 12 µg/unit dose<br>* 2 inhalations bid<br>* Other names: Foradil™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-dose morning PEF |  | End of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-dose FEV1 |  | At clinic visits | 
| Other spirometric parameters |  | At clinic visits | 
| Morning and evening asthma clinical symptom scores |  | End of treatment | 
| Percentage of night and/or days free of clinical symptoms |  | End of treatment | 
| Use of rescue short-acting b2-agonists |  | End of treatment | 
| Asthma exacerbations |  | end of treatment | 
| safety and tolerability |  | end of treatment |