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

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ClinicalTrials.gov Identifier: NCT00929851
Recruitment Status : Completed
First Posted : June 30, 2009
Last Update Posted : March 30, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: CHF1535 Drug: Formoterol fumarate Phase 3

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1199 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2009
Primary Completion Date : March 2012
Study Completion Date : July 2012


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Exacerbation rate Change in pre-dose FEV1 [ Time Frame: 0-4-12-24-36-48 weeks ]

Secondary Outcome Measures :
  1. Pulmonary function parameters(FEV1 - FVC) St George's Questionnaire Use of rescue medication [ Time Frame: 0-4-12-24-36-48 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications:
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
2009-012546-23 ( EudraCT Number )
First Posted: June 30, 2009    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Formoterol Fumarate
Beclomethasone
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
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
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists