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

Phase 3

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI; Drug: Budesonide 200 µg plus formoterol 6 µg DPI; Drug: Formoterol 12 µg DPI

• Registration Number: NCT00476099
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-05-18
• Study First Submitted QC: 2007-05-18
• Study First Posted: 2007-05-21
• Primary Completion: 2008-08
• Study Completion: 2008-11
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-28
• Last Update Posted: 2021-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 828

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Budesonide 200 µg plus formoterol 6 µg DPI	Budesonide 200 µg plus formoterol 6 µg DPI	-
Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI	Formoterol 12 µg DPI	-
Budesonide 200 µg plus formoterol 6 µg DPI	Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI	-
Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI	Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI	-
Budesonide 200 µg plus formoterol 6 µg DPI	Formoterol 12 µg DPI	-
Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI	Budesonide 200 µg plus formoterol 6 µg DPI	-
Formoterol 12 µg DPI	Formoterol 12 µg DPI	-
Formoterol 12 µg DPI	Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI	-
Formoterol 12 µg DPI	Budesonide 200 µg plus formoterol 6 µg DPI	-

Primary Outcome Measures

Name	Time	Method
Number of COPD exacerbations and pre-dose morning FEV1	one year treatment

Secondary Outcome Measures

Name	Time	Method
COPD symptom scores and Quality of Life,	one year treatment
Other pulmonary function parameters,	one year treatment
safety and tolerability	one year treatment

Trial Locations

Locations (1)

Thomas Similowski; 🇫🇷 Paris, France