Efficacy and Tolerability of Beclometasone/Formoterol Single Inhaler in Patients With Moderate to Severe Persistent Asthma
- Conditions
- Asthma
- Interventions
- Drug: Beclometasone dipropionate 250 µg/unit dose pMDIDrug: beclomethasone/formoterol (100/6µg) pMDI
- Registration Number
- NCT00476268
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- Brief Summary
Efficacy and tolerability of the fixed combination beclometasone/formoterol in patients with moderate to severe persistent asthma.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 824
-
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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Beclomethasone Beclometasone dipropionate 250 µg/unit dose pMDI Beclomethasone dipropionate (BecotideTM) 250 µg/unit dose pMDI aerosol via CFC propellant. beclometasone /formoterol beclomethasone/formoterol (100/6µg) pMDI beclomethasone dipropionate 100 µg plus formoterol 6 µg pMDI Formoterol powder 12 µg/unit dose Formoterol powder 12 µg/unit dose Formoterol powder 12 µg/unit dose (Foradil™)
- Primary Outcome Measures
Name Time Method Pre-dose morning PEF End of treatment
- Secondary Outcome Measures
Name Time Method Other spirometric parameters At clinic visits Use of rescue short-acting b2-agonists End of treatment Pre-dose FEV1 At clinic visits Asthma exacerbations end of treatment safety and tolerability end of treatment Morning and evening asthma clinical symptom scores End of treatment Percentage of night and/or days free of clinical symptoms End of treatment