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

Chronic Obstructive Pulmonary Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00476099
• Other study ID #: DM/PR/033011/005/05
• Secondary ID: 2006-002489-20
• Status: Completed
• Phase: Phase 3
• Start date: December 2006
• Est. completion date: November 2008

Study information

• Verified date: October 2021
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 828
• Est. completion date: November 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI
Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) two puffs via oral inhalation twice a day at 8.00 a.m. and 8.00 p.m.
• Budesonide 200 µg plus formoterol 6 µg DPI
two oral inhalations twice a day at 8.00 a.m. and 8.00 p.m.
• Formoterol 12 µg DPI
one oral inhalation twice a day at 8.00 a.m. and 8.00 p.m.

Locations

Country	Name	City	State
France	Thomas Similowski	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

France, 

References & Publications (2)

Calverley PM, Kuna P, Monsó E, Costantini M, Petruzzelli S, Sergio F, Varoli G, Papi A, Brusasco V. Beclomethasone/formoterol in the management of COPD: a randomised controlled trial. Respir Med. 2010 Dec;104(12):1858-68. doi: 10.1016/j.rmed.2010.09.008. — View Citation

Singh D, Corradi M, Spinola M, Petruzzelli S, Papi A. Extrafine beclometasone diproprionate/formoterol fumarate: a review of its effects in chronic obstructive pulmonary disease. NPJ Prim Care Respir Med. 2016 Jun 16;26:16030. doi: 10.1038/npjpcrm.2016.30. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of COPD exacerbations and pre-dose morning FEV1		one year treatment
Secondary	Other pulmonary function parameters,		one year treatment
Secondary	COPD symptom scores and Quality of Life,		one year treatment
Secondary	safety and tolerability		one year treatment

External Links

•   CSR Synopsis available in the CHIESI Clinical Study Register
•   Study Record on EU Clinical Trials Register including results