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

Phase 4

Completed

• Conditions: Severe Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Atrovent + Bricanyl or Atrovent + Ventoline; Drug: Placebo

• Registration Number: NCT02103374
• Lead Sponsor: University Hospital, Tours

Brief 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 ...).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2014-03-12
• Study First Submitted QC: 2014-03-31
• Study First Posted: 2014-04-03
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-26
• Last Update Posted: 2016-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Adult
• COPD Patients stage 3 et 4
• Has not submitted an exacerbation in the 3 months preceding the pre-inclusion visit
• Weaned from tobacco for at least 6 months
• vaccinated against pneumococcal
• Have not been included in a pulmonary rehabilitation program during the 6 months preceding the screening visit inclusion
• Patient pre-included not showing exacerbation since the pre-inclusion visit

Exclusion Criteria

• Patient under nebulizer or has been treated with nebulized bronchodilators at home over the last 6 months
• Patient with an indication of oxygen is expected in the coming year
• Progressive malignant disease known
• Patient under non-invasive ventilation (NIV) for less than 6 months or NIV provided in the following year
• Patient known to be colonized by Pseudomonas aeruginosa, A. xylosoxidans, Burkholderia cepacia or Stenotrophomonas maltophilia
• Patients with severe cardiovascular disease
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atrovent + Bricanyl or Atrovent + Ventolin	Atrovent + Bricanyl or Atrovent + Ventoline	3 daily inhalations of Atrovent mixture to form Bricanyl or Ventolin form Atrovent 0,5mg/1ml Bricanyl 5mg/2ml Ventolin 5mg/2,5ml
Placebo	Placebo	1 capsule per day lactose (in addition to the standard optimized treatment)

Primary Outcome Measures

Name	Time	Method
Score for quality of life, assessed by the questionnaire St Georges	Patients will be followed for the duration of their participation ie 48 weeks

Secondary Outcome Measures

Name	Time	Method
Score for quality of life, assessed by the questionnaire VQ11	Patients will be followed for the duration of their participation ie 48 weeks
Dyspnea score according Medical Research Council	Patients will be followed for the duration of their participation ie 48 weeks
Prognostic Score Mortality assessed by the score BODE	Patients will be followed for the duration of their participation ie 48 weeks

Trial Locations

Locations (1)

Service de Pneumologie; 🇫🇷 Tours, France