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

Sponsor
Chiesi Farmaceutici S.p.A. (Industry)
Overall Status
Completed
CT.gov ID
NCT00476099
Collaborator
(none)
828
Enrollment
1
Location
3
Arms
23
Duration (Months)
36
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • 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

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
828 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, 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)
Study Start Date :
Dec 1, 2006
Actual Primary Completion Date :
Aug 1, 2008
Actual Study Completion Date :
Nov 1, 2008

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Number of COPD exacerbations and pre-dose morning FEV1 [one year treatment]

Secondary Outcome Measures

  1. Other pulmonary function parameters, [one year treatment]

  2. COPD symptom scores and Quality of Life, [one year treatment]

  3. safety and tolerability [one year treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT00476099
Other Study ID Numbers:
  • DM/PR/033011/005/05
  • 2006-002489-20
First Posted:
May 21, 2007
Last Update Posted:
Oct 29, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Budesonide
Beclomethasone
Formoterol Fumarate

Study Results

No Results Posted as of Oct 29, 2021