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Sponsored by: |
Chiesi Farmaceutici S.p.A. |
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Information provided by: | Chiesi Farmaceutici S.p.A. |
ClinicalTrials.gov Identifier: | NCT00476099 |
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.
Condition | Intervention | Phase |
---|---|---|
Chronic Obstructive Pulmonary Disease |
Drug: CHF 1535, budesonide plus formoterol DPI, Formoterol DPI |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
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) |
Enrollment: | 828 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | August 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
Thomas Similowski | |
Paris, France, 75000 |
Principal Investigator: | Peter M.A. Calverley, Professor | Department of Medicine, Clinical Sciences Center University Hospital Aintree, Liverpool, United Kingdom |
Responsible Party: | Department of Medicine, Clinical Sciences Centre, University Hospital Aintree, Liverpool, UK ( Principal Investigator : Prof Peter M.A.Calverley ) |
Study ID Numbers: | DM/PR/033011/005/05 |
Study First Received: | May 18, 2007 |
Last Updated: | April 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00476099 |
Health Authority: | Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Bulgaria: Bulgarian Drug Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Germany: Federal Institute for Drugs and Medical Devices; Russia: Ministry of Health and Social Development of the Russian Federation; Ukraine: State Pharmacological Center - Ministry of Health; Spain: Spanish Agency of Medicines; France: Afssaps - French Health Products Safety Agency; Italy: The Italian Medicines Agency |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Respiration Disorders |
Budesonide Beclomethasone Formoterol Pulmonary Disease, Chronic Obstructive |
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic beta-Agonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents |
Glucocorticoids Hormones Adrenergic Agonists Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |