drugset / Trial / NCT02103374

Evaluation of Benefit of Nebulized Bronchodilators at Home in Severe Chronic Obstructive Pulmonary Disease and Very Severe Steady State

NCT02103374

Phase 4 Completed 45 enrolled University Hospital, Tours
RandomizedParallel-groupSingle-blind

Summary

Design studies of nebulization in COPD does not respond adequately to the clinically relevant question: the intervention of administering nebulized bronchodilators at home it is likely to make a profit, compared to the standard optimized treatment as defined by the recommendations of the SPLF, patients with severe COPD (stage III, FEV between 30% and 50% of the theoretical value) and very severe (stage IV, less than 30% of the theoretical value FEV)? The concept of profit in this context is based on criteria of dyspnea, quality of life, use of health system (exacerbations, hospitalizations, prescription of antibiotics and steroids ...).

Timeline

Start
2012-01
Primary completion
2015-12
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipratropium Small molecule 0.5 mg Inhaled
Subject Salbutamol Unknown 5 mg Inhaled
Subject Terbutaline Small molecule 5 mg Inhaled