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

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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00476099

Enrollment

828

Registered

2007-05-21

Start date

2006-12-31

Completion date

2008-11-30

Last updated

2021-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

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.

Interventions

DRUGBeclomethasone 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.

DRUGBudesonide 200 µg plus formoterol 6 µg DPI

two oral inhalations twice a day at 8.00 a.m. and 8.00 p.m.

DRUGFormoterol 12 µg DPI

one oral inhalation twice a day at 8.00 a.m. and 8.00 p.m.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Number of COPD exacerbations and pre-dose morning FEV1	one year treatment

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026