Efficacy and Safety Study of Beclometasone/Formoterol Single Inhaler in Patients With COPD
NCT ID: NCT00476099
Last Updated: 2021-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
828 participants
INTERVENTIONAL
2006-12-31
2008-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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) 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.
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) 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.
Formoterol 12 µg DPI
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
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Chiesi Farmaceutici S.p.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Peter M.A. Calverley, Professor
Role: PRINCIPAL_INVESTIGATOR
Department of Medicine, Clinical Sciences Center University Hospital Aintree, Liverpool, United Kingdom
Locations
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Thomas Similowski
Paris, , France
Countries
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References
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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.
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.
Related Links
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Study Record on EU Clinical Trials Register including results
CSR Synopsis available in the CHIESI Clinical Study Register
Other Identifiers
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2006-002489-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
DM/PR/033011/005/05
Identifier Type: -
Identifier Source: org_study_id