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: Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI Drug: Budesonide 200 µg plus formoterol 6 µg DPI Drug: Formoterol 12 µg DPI	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Beclomethasone dipropionate Formoterol fumarate Budesonide Formoterol Beclomethasone dipropionate monohydrate Arformoterol Tartrate

U.S. FDA Resources

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
Study Completion Date:	November 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI	Drug: 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. Drug: Budesonide 200 µg plus formoterol 6 µg DPI two oral inhalations twice a day at 8.00 a.m. and 8.00 p.m. Drug: Formoterol 12 µg DPI one oral inhalation twice a day at 8.00 a.m. and 8.00 p.m.
Active Comparator: Budesonide 200 µg plus formoterol 6 µg DPI	Drug: 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. Drug: Budesonide 200 µg plus formoterol 6 µg DPI two oral inhalations twice a day at 8.00 a.m. and 8.00 p.m. Drug: Formoterol 12 µg DPI one oral inhalation twice a day at 8.00 a.m. and 8.00 p.m.
Active Comparator: Formoterol 12 µg DPI	Drug: 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. Drug: Budesonide 200 µg plus formoterol 6 µg DPI two oral inhalations twice a day at 8.00 a.m. and 8.00 p.m. Drug: Formoterol 12 µg DPI one oral inhalation twice a day at 8.00 a.m. and 8.00 p.m.

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

No publications provided

Responsible Party:	Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:	NCT00476099 History of Changes
Other Study ID Numbers:	DM/PR/033011/005/05
Study First Received:	May 18, 2007
Last Updated:	January 29, 2013
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 of the Russian Federation Ukraine: State Pharmacological Center - Ministry of Health Spain: Spanish Agency of Medicines France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Italy: The Italian Medicines Agency

Additional relevant MeSH terms:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Beclomethasone
Budesonide
Formoterol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones

Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013