Official Title: “A 48-Week, Double Blind, Double Dummy, Randomised, Multinational, Multicentre, 3-Arm Parallel Group Clinical Study of "Fixed Combination" Beclometasone Dipropionate Plus Formoterol Fumarate Administered Via pMDI With HFA-134a Propellant Versus "Fixed Combination" Budesonide Plus Formoterol DPI Versus Formoterol DPI in Patients With Stable Severe Chronic Obstructive Pulmonary Disease (COPD)”

To evaluate the 1-year efficacy and safety of the fixed combination beclometasone/formoterol pMDI in a twice daily regimen in patients with stable severe COPD.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2008

The purpose of this study is to evaluate the long-term efficacy and safety of the fixed combination beclometasone/formoterol pMDI in a twice daily regimen in patients with stable severe COPD. Patients are randomised to receive either beclometasone/formoterol or budesonide/formoterol DPI or formoterol DPI during 48 weeks of treatment.

Intervention(s) in this Clinical Trial

• Drug: CHF 1535, budesonide plus formoterol DPI, Formoterol DPI

Primary Measures

• Number of COPD exacerbations and pre-dose morning FEV1
  • Time Frame: one year treatment
    Safety Issue?: Yes

Secondary Measures

• Other pulmonary function parameters,
  • Time Frame: one year treatment
    Safety Issue?: No
• COPD symptom scores and Quality of Life,
  • Time Frame: one year treatment
    Safety Issue?: Yes
• safety and tolerability
  • Time Frame: one year treatment
    Safety Issue?: Yes

Inclusion Criteria:

• Clinical diagnosis of COPD (according to GOLD guidelines)
• FEV1 > or equal 30% and < 50% of predicted normal post-bronchodilator (and at least 0.7 L absolute value)
• COPD symptoms for at least 2 years
• At least 1 exacerbation requiring medical intervention (oral corticosteroid and/or antibiotic treatment and/or need for a visit to an emergency department and/or hospitalization) within 2-12 months before screening
• Current or previous smoker with a cumulative exposure to smoke of more than 20-pack year

Exclusion Criteria:

• Current or past diagnosis of asthma, or any evidence suggestive of asthma
• Positive FEV1 reversibility test
• Clinically significant or unstable concurrent diseases, including clinically significant laboratory abnormalities
• Acute COPD exacerbation or lower tract infection and/or treatment with oral or injectable corticosteroids and antibiotics in the 2 months before screening or during run-in
• Long term oxygen therapy

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 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

Peter M.A. Calverley, Professor Principal Investigator Department of Medicine, Clinical Sciences Center University Hospital Aintree, Liverpool, United Kingdom  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00476099

Study ID Number: DM/PR/033011/005/05

ClinicalTrials.gov Identifier: NCT00476099

Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products