Efficacy and Safety Study of Beclometasone/Formoterol Single Inhaler in Patients With COPD - Full Text View

Purpose

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

MedlinePlus related topics:

COPD (Chronic Obstructive Pulmonary Disease)

ChemIDplus related topics:

Formoterol Arformoterol Arformoterol Tartrate Formoterol fumarate Budesonide Beclomethasone dipropionate Beclomethasone HFA 227

U.S. FDA Resources

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)

Further study details as provided by Chiesi Farmaceutici S.p.A.:

Primary Outcome Measures:

Number of COPD exacerbations and pre-dose morning FEV1 [ Time Frame: one year treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Other pulmonary function parameters, [ Time Frame: one year treatment ] [ Designated as safety issue: No ]
COPD symptom scores and Quality of Life, [ Time Frame: one year treatment ] [ Designated as safety issue: Yes ]
safety and tolerability [ Time Frame: one year treatment ] [ Designated as safety issue: Yes ]

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)

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

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00476099

Locations


France
	Thomas Similowski
	Paris, France, 75000

Sponsors and Collaborators

Chiesi Farmaceutici S.p.A.

Investigators


Principal Investigator:	Peter M.A. Calverley, Professor	Department of Medicine, Clinical Sciences Center University Hospital Aintree, Liverpool, United Kingdom

More Information

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
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

Study placed in the following topic categories:

Lung Diseases, Obstructive

Respiratory Tract Diseases

Lung Diseases

Budesonide

Beclomethasone

Formoterol

Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Chiesi Farmaceutici S.p.A.
Information provided by:	Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:	NCT00476099