Clinical trial NCT01911364: Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate in Chronic Obstructive Pulmonary Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Frequent exacerbators
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2013-07-30
Enrollment: 3686
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Detailed description: A 52-WEEK, DOUBLE BLIND, DOUBLE DUMMY, RANDOMIZED, 3-ARM PARALLEL GROUP, ACTIVE CONTROLLED CLINICAL TRIAL OF FIXED COMBINATION OF BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE PLUS GLYCOPYRROLATE BROMIDE ADMINISTERED VIA PMDI (CHF 5993) VERSUS TIOTROPIUM BROMIDE AND VERSUS FIXED COMBINATION OF BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE ADMINISTERED VIA PMDI AND TIOTROPIUM BROMIDE IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE

A total of 8 clinic visits (V0 to V7) will be performed during the study, as follows:

* A pre-screening visit (V0) to obtain the written informed consent from the patient
* A screening visit (V1) to establish the eligibility of patients, followed by a 2-week open-label run-in under Tiotropium
* After the randomisation (V2), patients will be assessed after 4, 12, 26, 40 and 52 weeks of treatment (V3 to V7) The assessments performed at visits include routine haematology and blood chemistry, medical history, physical examination, a 12-lead ECG, spirometric parameters, vital signs).

During the run-in and the randomised treatment periods, patients use an e-diary to record symptoms, rescue medication use and compliance to the study medications daily.

AEs/SAEs and COPD exacerbations will be monitored.

Eligibility 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

Primary outcomes:
measure: COPD exacerbation rate
timeFrame: 52 weeks
Secondary outcomes:
measure: pre-dose morning FEV1
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Hessen
country: Germany
facility: Institut für klinische Forschung
city: Szeged
country: Hungary
facility: Csongrád Megyei Mellkasi Betegségek Szakkórháza
city: Perugia
country: Italy
facility: Azienda Ospedaliera Perugia
Study officials:
affiliation: Respiratory Research Group, Wythenshawe Hospital, MANCHESTER
name: Jorgen Vestbo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.