Efficacy and Safety Study of Beclometasone/Formoterol Single Inhaler in Patients With COPD
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)
2 other identifiers
interventional
828
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 chronic-obstructive-pulmonary-disease
Started Dec 2006
Typical duration for phase_3 chronic-obstructive-pulmonary-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 18, 2007
CompletedFirst Posted
Study publicly available on registry
May 21, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedOctober 29, 2021
October 1, 2021
1.7 years
May 18, 2007
October 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Number of COPD exacerbations and pre-dose morning FEV1
one year treatment
Secondary Outcomes (3)
Other pulmonary function parameters,
one year treatment
COPD symptom scores and Quality of Life,
one year treatment
safety and tolerability
one year treatment
Study Arms (3)
Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI
EXPERIMENTALBudesonide 200 µg plus formoterol 6 µg DPI
ACTIVE COMPARATORFormoterol 12 µg DPI
ACTIVE COMPARATORInterventions
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.
two oral inhalations twice a day at 8.00 a.m. and 8.00 p.m.
one oral inhalation twice a day at 8.00 a.m. and 8.00 p.m.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Thomas Similowski
Paris, 75000, France
Related Publications (2)
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.
PMID: 27309985BACKGROUNDCalverley 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.
PMID: 20965712RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter M.A. Calverley, Professor
Department of Medicine, Clinical Sciences Center University Hospital Aintree, Liverpool, United Kingdom
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2007
First Posted
May 21, 2007
Study Start
December 1, 2006
Primary Completion
August 1, 2008
Study Completion
November 1, 2008
Last Updated
October 29, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will share
- Access Criteria
- Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.
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.