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)
Verified date | October 2021 |
Source | Chiesi Farmaceutici S.p.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | Thomas Similowski | Paris |
Lead Sponsor | Collaborator |
---|---|
Chiesi Farmaceutici S.p.A. |
France,
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
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 |
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