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
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: 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 July 22, 2014