Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate in Chronic Obstructive Pulmonary Disease

Study Identifier:
CCD-1208-PR-0090
ClinicalTrials.gov Identifier:
NCT01911364
EudraCT Identifier:
2013-000063-91
EU CT ID:
N/A
Study Contact Information:
N/A
See Study Publication Below
Study Complete

Trial Documents

Clinical Study Report
Available Languages: English
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Study Details

Medical Condition
  • Chronic Obstructive Pulmonary Disease
Study Drug
  • Drug: BDP/FF/GB
  • Drug: Tiotropium
  • Drug: BDP/FF + Tiotropium
Date
Jan 2014 - Mar 2016
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 40+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • 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
Exclusion Criteria
  • 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
Healthy Volunteers
No

Protocol 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)

Study Locations

Location
Status
Location
Institut für klinische Forschung
Hessen, Germany
Status
N/A
Location
Csongrád Megyei Mellkasi Betegségek Szakkórháza
Szeged, Hungary
Status
N/A
Location
Azienda Ospedaliera Perugia
Perugia, Italy
Status
N/A

Study Publications

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.Singh 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.Singh 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.Vestbo 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.