Clinical trial NCT00476099: Efficacy and Safety Study of Beclometasone/Formoterol Single Inhaler in Patients With COPD
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2007-05-21
Enrollment: 828
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of COPD exacerbations and pre-dose morning FEV1
timeFrame: one year treatment
Secondary outcomes:
measure: Other pulmonary function parameters,
timeFrame: one year treatment
measure: COPD symptom scores and Quality of Life,
timeFrame: one year treatment
measure: safety and tolerability
timeFrame: one year treatment
Other outcomes:
Locations:
city: Paris
country: France
facility: Thomas Similowski
Study officials:
affiliation: Department of Medicine, Clinical Sciences Center University Hospital Aintree, Liverpool, United Kingdom
name: Peter M.A. Calverley, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Calverley PM, Kuna P, Monso 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. Epub 2010 Oct 20.