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Efficacy and Safety Study of Beclometasone/Formoterol Single Inhaler in Patients With COPD

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00476099
First Posted: May 21, 2007
Last Update Posted: March 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


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 ]

Secondary Outcome Measures:
  • Other pulmonary function parameters, [ Time Frame: one year treatment ]
  • COPD symptom scores and Quality of Life, [ Time Frame: one year treatment ]
  • safety and tolerability [ Time Frame: one year treatment ]

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

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:

  • 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
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): 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

Additional Information:
Publications:
Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT00476099     History of Changes
Other Study ID Numbers: DM/PR/033011/005/05
2006-002489-20 ( EudraCT Number )
First Submitted: May 18, 2007
First Posted: May 21, 2007
Last Update Posted: March 30, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Formoterol Fumarate
Budesonide
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