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 2, 2013
Last verified: August 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 2, 2013
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:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Lung Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Formoterol
Beclomethasone
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 16, 2014