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BDP/FF Versus Formoterol Fumarate (FF) in Patients With Severe COPD (Lung Function and Exacerbation Rate)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT00929851
First received: June 29, 2009
Last updated: August 1, 2012
Last verified: July 2012
History of Changes
  Purpose

a 48-week, 2-arm parallel group, "fixed combination" beclomethasone dipropionate plus formoterol fumarate versus formoterol in patients with severe chronic obstructive pulmonary disease


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
 Drug: CHF1535
Drug: Formoterol fumarate
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: a 48-week, Double Blind, Randomized, Multinational, Multicentre, "Fixed Combination" Beclomethasone Dipropionate Plus Formoterol Fumarate Versus Formoterol in Patients With Severe Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Exacerbation rate Change in pre-dose FEV1 [ Time Frame: 0-4-12-24-36-48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pulmonary function parameters(FEV1 - FVC) St George's Questionnaire Use of rescue medication [ Time Frame: 0-4-12-24-36-48 weeks ] [ Designated as safety issue: No ]

Enrollment: 1199
Study Start Date: October 2009
Study Completion Date: July 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BDP/FF
Beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg/per metered dose inhaler
 Drug: CHF1535
Beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg/per metered dose
Other Name: Foster, Fostair
Active Comparator: Formoterol fumarate
Formoterol fumarate 12 µg per metered dose
 Drug: Formoterol fumarate
Formoterol fumarate 12 µg per metered dose
Other Name: Atimos

Detailed Description:

a 48-week, double blind, randomized, multinational, multicentre, 2-arm parallel group, reference treatment controlled clinical trial of "fixed combination" beclomethasone dipropionate plus formoterol fumarate versus formoterol in patients with severe chronic obstructive pulmonary disease

  Eligibility

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

Inclusion Criteria:

  • Severe COPD
  • At least one COPd exacerbation in previous year

Exclusion Criteria:

  • Asthma, allergic rhinitis or other atopic disease
  • Unstable concurrent disease:
  • Evidence of heart failure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00929851

Locations
United Kingdom
UCL Medical School
London, United Kingdom
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
Principal Investigator: Jadwiga A Wedzicha, MD, Prof UCL MEDICAL SCHOOL
  More Information

No publications provided by Chiesi Farmaceutici S.p.A.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT00929851     History of Changes
Other Study ID Numbers: CCD-0906-PR-0016
Study First Received: June 29, 2009
Last Updated: August 1, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Agency for Health and Food Safety
Ireland: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Beclomethasone
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
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on June 18, 2013