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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT00476099
First received: May 18, 2007
Last updated: January 29, 2013
Last verified: April 2008
  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:


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 April 16, 2014