Official Title: “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”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Fixed combination Beclomethasone/formoterol HFA 134a-pMDI

Primary Measures

• Pre-dose morning PEF
  • Time Frame: End of treatment
    

Secondary Measures

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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Chiesi Farmaceutici S.p.A.

Overall Clinical Trial Officials and Contacts

Francoise Bonnet-Gonod Study Director Chiesi Farmaceutici  

Information obtained from ClinicalTrials.gov on October 15, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00476268

Study ID Number: DM/PR/033011/003/03

ClinicalTrials.gov Identifier: NCT00476268

Health Authority: Belgium: Directorate general for the protection of Public health: Medicines