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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI
Budesonide 200 µg plus formoterol 6 µg DPI
Formoterol 12 µg DPI
Sponsored by
Chiesi Farmaceutici S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Thomas Similowski

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI

Budesonide 200 µg plus formoterol 6 µg DPI

Formoterol 12 µg DPI

Arm Description

Outcomes

Primary Outcome Measures

Number of COPD exacerbations and pre-dose morning FEV1

Secondary Outcome Measures

Other pulmonary function parameters,
COPD symptom scores and Quality of Life,
safety and tolerability

Full Information

First Posted
May 18, 2007
Last Updated
October 28, 2021
Sponsor
Chiesi Farmaceutici S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT00476099
Brief Title
Efficacy and Safety Study of Beclometasone/Formoterol Single Inhaler in Patients With COPD
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 Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiesi Farmaceutici S.p.A.

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
828 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI
Arm Type
Experimental
Arm Title
Budesonide 200 µg plus formoterol 6 µg DPI
Arm Type
Active Comparator
Arm Title
Formoterol 12 µg DPI
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Budesonide 200 µg plus formoterol 6 µg DPI
Intervention Description
two oral inhalations twice a day at 8.00 a.m. and 8.00 p.m.
Intervention Type
Drug
Intervention Name(s)
Formoterol 12 µg DPI
Intervention Description
one oral inhalation twice a day at 8.00 a.m. and 8.00 p.m.
Primary Outcome Measure Information:
Title
Number of COPD exacerbations and pre-dose morning FEV1
Time Frame
one year treatment
Secondary Outcome Measure Information:
Title
Other pulmonary function parameters,
Time Frame
one year treatment
Title
COPD symptom scores and Quality of Life,
Time Frame
one year treatment
Title
safety and tolerability
Time Frame
one year treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter M.A. Calverley, Professor
Organizational Affiliation
Department of Medicine, Clinical Sciences Center University Hospital Aintree, Liverpool, United Kingdom
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Similowski
City
Paris
ZIP/Postal Code
75000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Chiesi commits to sharing with qualified scientific and medical Researchers, conducting legitimate research, Patient-level Data, Study-level Data, the Clinical Protocol and the full CSR, providing access to clinical trial information consistently with the principle of safeguarding commercially confidential information and patient privacy. Any shared Patient-level Data is anonymized to protect personally identifiable information. Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.
IPD Sharing Access Criteria
Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.
IPD Sharing URL
https://www.chiesi.com/en/chiesi-clinical-trial-data-request-portal/
Citations:
PubMed Identifier
27309985
Citation
Singh D, Corradi M, Spinola M, Petruzzelli S, Papi A. Extrafine beclometasone diproprionate/formoterol fumarate: a review of its effects in chronic obstructive pulmonary disease. NPJ Prim Care Respir Med. 2016 Jun 16;26:16030. doi: 10.1038/npjpcrm.2016.30.
Results Reference
background
PubMed Identifier
20965712
Citation
Calverley PM, Kuna P, Monso E, Costantini M, Petruzzelli S, Sergio F, Varoli G, Papi A, Brusasco V. Beclomethasone/formoterol in the management of COPD: a randomised controlled trial. Respir Med. 2010 Dec;104(12):1858-68. doi: 10.1016/j.rmed.2010.09.008. Epub 2010 Oct 20.
Results Reference
result
Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/search?query=2006-002489-20
Description
Study Record on EU Clinical Trials Register including results
URL
https://www.chiesi.com/clinic/82_CSR_Synopsis_DM-PR-033011-005-05.pdf
Description
CSR Synopsis available in the CHIESI Clinical Study Register

Learn more about this trial

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

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