Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
A Phase 3 Randomised Double Blind Randomised Parallel Multinational Trial Comparing a Fixed Combination of Beclometasone+Formoterol+Glycopyrrolate to Foster® 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 |
Randomized,double-blind,multicenter,multinational,parallel-group,Phase III study to demonstrate the superiority of the triple fixed combination of Beclometasone+Formoterol+Glycopyrrolate (BDP/FF/GB) administered via pMDI over the equivalent dose of Foster® in COPD (Chronic Obstructive Pulmonary Disease) patients after 52 weeks of treatment
Status | Completed |
Enrollment | 1368 |
Est. completion date | March 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | Inclusion Criteria: - Male or female adults aged = 40 years with a diagnosis of COPD - Current smokers or ex-smokers - A post-bronchodilator FEV1 < 50% of the predicted normal value and a post- bronchodilator FEV1/FVC < 0.7 - At least one exacerbation in the 12 months preceding the screening visit Exclusion Criteria: - Pregnant or lactating women - Diagnosis of asthma or history of allergic rhinitis or atopy - Patients treated with non-cardioselective ß-blockers in the month preceding the screening visit - Patients treated for exacerbations in the 4 weeks prior to screening visit - Patients treated with long-acting antihistamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study or if taken as PRN - Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia - Known respiratory disorders other than COPD - Patients who have clinically significant cardiovascular condition |
Country | Name | City | State |
---|---|---|---|
Hungary | Dr Beatrix BALINT | Szeged |
Lead Sponsor | Collaborator |
---|---|
Chiesi Farmaceutici S.p.A. |
Hungary,
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
Singh D, Papi A, Corradi M, Pavlišová I, Montagna I, Francisco C, Cohuet G, Vezzoli S, Scuri M, Vestbo J. Single inhaler triple therapy versus inhaled corticosteroid plus long-acting ß2-agonist therapy for chronic obstructive pulmonary disease (TRILOGY): — 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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pre-dose and 2-hour post-dose morning FEV1 at week 26 and TDI score at week 26 | Change from baseline in pre-dose morning FEV1 at Week 26. Change from baseline to the 2-hour post-dose value of FEV1 at Week 26. TDI focal score at Week 26 |
week 26 | |
Secondary | COPD exacerbation rate | Moderate and severe COPD exacerbation rate over 52 weeks of treatment | week 52 |
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