Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate in Chronic Obstructive Pulmonary Disease
A 52-wk Randomized Double Blind Parallel Trial: Combination of Beclometasone+Formoterol+Glycopyrrolate vs Tiotropium and vs Combination of Beclometasone+Formoterol and Tiotropium in Patients With Chronic Obstructive Pulmonary Disease
2 other identifiers
interventional
3,686
3 countries
3
Brief Summary
The purpose of this study is to determine the triple combination of beclometasone dipropionate+Formoterol fumarate+Glycopyrrolate bromide is effective for the treatment of severe COPD patients (chronic obstructive pulmonary disease)
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 Jan 2014
Typical duration for phase_3 chronic-obstructive-pulmonary-disease
3 active sites
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
First Submitted
Initial submission to the registry
July 26, 2013
CompletedFirst Posted
Study publicly available on registry
July 30, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedOctober 29, 2021
October 1, 2021
2.2 years
July 26, 2013
October 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
COPD exacerbation rate
Moderate and severe COPD exacerbation rate over 52 weeks of treatment.
52 weeks
Secondary Outcomes (1)
pre-dose morning FEV1
52 weeks
Study Arms (3)
BDP/FF/GB
EXPERIMENTALCHF 5993 pMDI 100/6/12.5 mcg 2 inhalations b.i.d
Tiotropium
ACTIVE COMPARATORTiotropium bromide 18 mcg
BDP/FF + Tiotropium
ACTIVE COMPARATORBDP/FF pMDI 100/6/12.5 mcg 2 inhalations b.i.d and Tiotropium 18 mcg daily BDP/FF/GB versus BDP/FF + Tiotropium
Interventions
Superiority of CHF5993 over Tiotropium
non inferiority vs CHF5993
Eligibility Criteria
You may qualify if:
- Male and female COPD patients aged ≥ 40 years
- Current smokers or ex-smokers
- FEV1\<50% predicted (FEV1/FVC \<0,7)
- at least 1 documented exacerbations in the last 12 Mo
You may not qualify if:
- Pregnant or lactating women and all women physiologically capable of becoming pregnant
- Diagnosis of asthma, history of allergic rhinitis or atopy
- Patients treated for exacerbations 1 Mo prior to screening
- Patients treated with non-cardioselective β-blockers
- Patients treated with long-acting antihistamines
- Known respiratory disorders other than COPD
- Patients who have clinically significant cardiovascular condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Institut für klinische Forschung
Hessen, Germany
Csongrád Megyei Mellkasi Betegségek Szakkórháza
Szeged, Hungary
Azienda Ospedaliera Perugia
Perugia, Italy
Related Publications (4)
Vanfleteren L, Fabbri LM, Papi A, Petruzzelli S, Celli B. Triple therapy (ICS/LABA/LAMA) in COPD: time for a reappraisal. Int J Chron Obstruct Pulmon Dis. 2018 Dec 12;13:3971-3981. doi: 10.2147/COPD.S185975. eCollection 2018.
PMID: 30587953BACKGROUNDSingh D, Fabbri LM, Vezzoli S, Petruzzelli S, Papi A. Extrafine triple therapy delays COPD clinically important deterioration vs ICS/LABA, LAMA, or LABA/LAMA. Int J Chron Obstruct Pulmon Dis. 2019 Feb 28;14:531-546. doi: 10.2147/COPD.S196383. eCollection 2019.
PMID: 30880943BACKGROUNDSingh D, Fabbri LM, Corradi M, Georges G, Guasconi A, Vezzoli S, Petruzzelli S, Papi A. Extrafine triple therapy in patients with symptomatic COPD and history of one moderate exacerbation. Eur Respir J. 2019 May 18;53(5):1900235. doi: 10.1183/13993003.00235-2019. Print 2019 May.
PMID: 30792343BACKGROUNDVestbo J, Papi A, Corradi M, Blazhko V, Montagna I, Francisco C, Cohuet G, Vezzoli S, Scuri M, Singh D. Single inhaler extrafine triple therapy versus long-acting muscarinic antagonist therapy for chronic obstructive pulmonary disease (TRINITY): a double-blind, parallel group, randomised controlled trial. Lancet. 2017 May 13;389(10082):1919-1929. doi: 10.1016/S0140-6736(17)30188-5. Epub 2017 Apr 3.
PMID: 28385353RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jorgen Vestbo, MD
Respiratory Research Group, Wythenshawe Hospital, MANCHESTER
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
July 26, 2013
First Posted
July 30, 2013
Study Start
January 1, 2014
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
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.