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

Study Overview
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Brief Summary
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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 ...).

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

Conditions
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Severe Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: Atrovent + Bricanyl or Atrovent + Ventoline
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atrovent + Bricanyl or Atrovent + Ventolin<br>3 daily inhalations of Atrovent mixture to form Bricanyl or Ventolin form Atrovent 0,5mg/1ml Bricanyl 5mg/2ml Ventolin 5mg/2,5ml | Drug: Atrovent + Bricanyl or Atrovent + Ventoline<br>* 3 daily inhalations of Atrovent mixture to form Bricanyl or Ventolin form during 48 weeks<br>|
| Placebo Comparator: Placebo<br>1 capsule per day lactose (in addition to the standard optimized treatment) | Drug: Placebo<br>* 1 capsule lactose during 48 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weaned tobacco, Has not submitted an exacerbation in the past 3 months