NCT02103374

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: University Hospital, Tours · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 ...).

Conditions

• Severe Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Atrovent + Bricanyl or Atrovent + Ventoline	3 daily inhalations of Atrovent mixture to form Bricanyl or Ventolin form during 48 weeks
DRUG	Placebo	1 capsule lactose during 48 weeks

Timeline

• Start date: 2012-01-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2014-04-03
• Last updated: 2016-04-27

Locations

13 sites across 1 country: France