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

NCT02103374 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2016-04-27

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University Hospital, Tours

    lead OTHER

Principal Investigators

  • Patrice DIOT, MD-PhD · University Hospital, Tours

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02103374 on ClinicalTrials.gov