Impact of Fixed TRIple Therapy With Beclometasone/Formoterol/Glycopyrronium DPI (Trimbow® in NEXThaler Device) in Chronic Obstructive PulmoNary Disease in rEal-world Settings: Health-related Quality of Life Patient' eXpectations and characterisTics: the TriNEXT Study
NCT05948891 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500
Last updated 2024-03-13
Summary
This is an observational, prospective, multicentric, cohort study conducted in France to evaluate the QoL in COPD patients treated with TRIMBOW NEXThaler 88/5/9 in a routine clinical practice setting. Patients enrolled in this study will be patients diagnosed with a COPD with a ratio of post-bronchodilator (salbutamol 400 μg) forced expiratory volume in 1 s (FEV1) to forced vital capacity (FVC) of less than 0.7 to whom TRIMBOW NEXThaler 88/5/9 has been initiated by an hospital or local pulmonologists in accordance with clinical practice and marketing authorization.
Conditions
Interventions
- DRUG
-
Beclometasone/Formoterol/Glycopyrronium 88 µg/5 µg/9 µg DPI (Trimbow® 88 µg/5 µg/9 µg in NEXThaler device)
observational, prospective, multicentric, international, cohort study
Sponsors & Collaborators
-
Kappa Santé
collaborator INDUSTRY -
Chiesi SAS
lead INDUSTRY
Principal Investigators
-
Capucine MORELOT PANZINI, Pr · University Hospital, la pitié salpêtrière
-
Philippe DEVILLIER, Pr · HOSPITAL, FOCH
-
Hervé PEGLIASCO, Dr · European Hospital, Marseille
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-01
- Primary Completion
- 2024-12-31
- Completion
- 2025-03-31
Countries
- France
Study Locations
More Related Trials
-
Triple Therapy Convenience by the Use of One or Multiple Inhalers and Digital Support in Chronic Obstructive Pulmonary Disease
NCT05495698 ·Status: RECRUITING ·Phase: NA
-
TRIMBOW® and RELVAR® on Lung Stiffness Reduction Assessed Through Forced Oscillation Technique in Patients With COPD
NCT04671355 ·Status: WITHDRAWN ·Phase: PHASE4
-
Study of Fluticasone/Formoterol/Glycopyrronium for the Treatment Chronic Obstructive Pulmonary Disease (TRIPLAR)
NCT06234345 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
Multinational Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis
NCT05255991 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis
NCT04708782 ·Status: COMPLETED ·Phase: PHASE3
-
ALK27-001: A Study of Trospium Inhalation Powder (TrIP)Administered to Subjects With COPD
NCT00801684 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase II Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Single Inhaled Doses of Ensifentrine-glycopyrrolate Fixed Dose Combination, Ensifentrine, and Glycopyrrolate in Subjects With Chronic Obstructive Pulmonary Disease
NCT07132983 ·Status: COMPLETED ·Phase: PHASE2
-
Non-interventional Study Related to Fixed LAMA/LABA/ICS Triple Therapy
NCT04355546 ·Status: COMPLETED
-
Efficacy of Inhaled Therapies in the Treatment of Acute Symptoms Associated With COVID-19
NCT04937543 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Tolerability of Symbicort as an add-on Treatment to Spiriva Compare With Spiriva Alone in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT01397890 ·Status: COMPLETED ·Phase: PHASE4
-
Tiotropium / Respimat One-Year Study
NCT00168831 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Trospium Chloride Inhalation Powder (TrIP) in Patients With Chronic Obstructive Pulmonary Disease
NCT00465959 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Advanced Immunological Approach in COPD Exacerbation
NCT02417649 ·Status: COMPLETED ·Phase: PHASE4
-
Placebo-controlled, Single and Multiple Dose Study in Healthy Volunteers and Refractory Chronic Cough Patients to Assess the Safety, Tolerability, and Pharmacokinetics of Two Formulations of NTX-1175
NCT05628740 ·Status: COMPLETED ·Phase: PHASE1
-
Inhaled Treprostinil (Tyvaso Nebulizer) For COPD Patients With Hypoxemia
NCT07037836 ·Status: RECRUITING ·Phase: PHASE2
-
Inhaled Nebulized Tobramycin in Non-cystic Fibrosis Bronchiectasis
NCT02657473 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Efficacy and Safety of Tiotropium in Patients With COPD and Concomitant Diagnosis of Asthma
NCT00152984 ·Status: COMPLETED ·Phase: PHASE4
-
Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA -1)
NCT06959095 ·Status: RECRUITING ·Phase: PHASE3
-
Evaluation of Tiotropium 5 µg/Day Delivered Via the Respimat® Inhaler Over 48 Weeks in Patients With Severe Persistent Asthma on Top of Usual Care (Study II)
NCT00776984 ·Status: COMPLETED ·Phase: PHASE3
-
Inhaled Treprostinil for Dyspnea and Exercise Intolerance in Mild COPD
NCT06969573 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Single Ascending Dose Study of TRN-157 in Healthy Subjects
NCT02133339 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Clinical and Patient-reported Outcomes in Adults With Moderate to Severe COPD Treated With Breztri/Trixeo
NCT07069829 ·Status: RECRUITING
-
Study to Assess Safety, Feasibility, and Preliminary Efficacy of the Apreo Implant for Severe Emphysema
NCT05949645 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Bioequivalence Study of Tiotropium 18 μg Inhalation Powder, Hard Capsule With Spiriva®Handihaler® 18 μg Inhalation Powder, Hard Capsule in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT05986591 ·Status: COMPLETED ·Phase: PHASE3
-
Tiotropium / Respimat One-Year Study
NCT00168844 ·Status: COMPLETED ·Phase: PHASE3