Chronic Obstructive Pulmonary Disease Clinical Trial
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
Verified date | October 2021 |
Source | Chiesi Farmaceutici S.p.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
Status | Completed |
Enrollment | 3686 |
Est. completion date | March 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | 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 ß-blockers - Patients treated with long-acting antihistamines - Known respiratory disorders other than COPD - Patients who have clinically significant cardiovascular condition |
Country | Name | City | State |
---|---|---|---|
Germany | Institut für klinische Forschung | Hessen | |
Hungary | Csongrád Megyei Mellkasi Betegségek Szakkórháza | Szeged | |
Italy | Azienda Ospedaliera Perugia | Perugia |
Lead Sponsor | Collaborator |
---|---|
Chiesi Farmaceutici S.p.A. |
Germany, Hungary, Italy,
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). pii: 1900235. doi: 10.1183/13993003.00235-2019. Print 2019 May. — View 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. — View 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. Review. — View 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- — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | COPD exacerbation rate | Moderate and severe COPD exacerbation rate over 52 weeks of treatment. | 52 weeks | |
Secondary | pre-dose morning FEV1 | Change from baseline in pre-dose morning FEV1 at Week 52. | 52 weeks |
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