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This study aims to evaluate the impact of long-term home non-invasive ventilation (NIV) on patients with COPD
Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide . A subset of patients develops chronic hypercapnia, which is linked to frequent hospitalizations, reduced quality of life, and poor survival. Despite optimized pharmacological therapy, pulmonary rehabilitation, and long-term oxygen therapy (LTOT), outcomes in these patients remain unsatisfactory. Early randomized trials failed to show survival benefit from home Non Invasive Ventilation , largely due to low ventilatory pressures, poor adherence, and heterogeneous patient selection . More recent studies suggest a positive impact and demonstrated improved long-term survival, some studies reported reduced mortality with high-intensity NIV targeting PaCO₂ reduction . Meta-analyses indicate that patients with persistent hypercapnia after an acute exacerbation are most likely to benefit , though uncertainties remain regarding patient selection and long-term real-world outcomes. Management of chronic hypercapnic COPD currently includes pharmacological treatment, LTOT, and rehabilitation. NIV is a cornerstone in acute exacerbations, but its role in the chronic setting is not universally established, and routine use in home care is limited.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
Start Date
January 1, 2026
Primary Completion Date
January 1, 2027
Completion Date
January 1, 2028
Last Updated
September 30, 2025
40
ESTIMATED participants
BiPAP device (non invasive ventilation)
DEVICE
Optimal Medical Management ( long acting beta agonist , long acting muscarinic antagonist and inhaled corticosteroids)
DRUG
Lead Sponsor
Assiut University
NCT07477600
NCT07462221
NCT07351929
Data Source & Attribution
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