Efficacy and Safety Study of Beclometasone/Formoterol Single Inhaler in Patients With COPD

Chiesi

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Budesonide 200 µg plus formoterol 6 µg DPI; Drug: Formoterol 12 µg DPI; Drug: Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI

Study type: Interventional

Funder types: Industry

Identifiers

NCT00476099

DM/PR/033011/005/05

2006-002489-20 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 828 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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828 participants in 3 patient groups

Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI

Experimental group

Treatment:

Drug: Formoterol 12 µg DPI

Drug: Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI

Drug: Budesonide 200 µg plus formoterol 6 µg DPI

Budesonide 200 µg plus formoterol 6 µg DPI

Active Comparator group

Treatment:

Drug: Formoterol 12 µg DPI

Drug: Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI

Drug: Budesonide 200 µg plus formoterol 6 µg DPI

Formoterol 12 µg DPI

Active Comparator group

Treatment:

Drug: Formoterol 12 µg DPI

Drug: Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI

Drug: Budesonide 200 µg plus formoterol 6 µg DPI