Clinical trial NCT02103374: Evaluation of Benefit of Nebulized Bronchodilators at Home in Severe Chronic Obstructive Pulmonary Disease and Very Severe Steady State
Official title: Evaluation of Benefit of Nebulized Bronchodilators at Home in Severe Chronic Obstructive Pulmonary Disease and Very Severe Steady State
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Severe Chronic Obstructive Pulmonary Disease
Keywords: weaned tobacco
Has not submitted an exacerbation in the past 3 months
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2014-04-03
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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 ...).


Eligibility criteria: 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

Primary outcomes:
measure: Score for quality of life, assessed by the questionnaire St Georges
timeFrame: Patients will be followed for the duration of their participation ie 48 weeks
Secondary outcomes:
measure: Score for quality of life, assessed by the questionnaire VQ11
timeFrame: Patients will be followed for the duration of their participation ie 48 weeks
measure: Dyspnea score according Medical Research Council
timeFrame: Patients will be followed for the duration of their participation ie 48 weeks
measure: Prognostic Score Mortality assessed by the score BODE
timeFrame: Patients will be followed for the duration of their participation ie 48 weeks
Other outcomes:
measure: Number of exacerbations
timeFrame: Patients will be followed for the duration of their participation ie 48 weeks
measure: Number of hospitalizations
timeFrame: Patients will be followed for the duration of their participation ie 48 weeks
Locations:
city: Amiens
country: France
facility: Service de Pneumologie
city: Angers
country: France
facility: Service de Pneumologie
city: Brest
country: France
facility: Service de Pneumologie
city: Grenoble
country: France
facility: Service de Pneumologie
city: Limoges
country: France
facility: Service de Pneumologie
city: Nancy
country: France
facility: Service de Pneumologie
city: Nantes
country: France
facility: Service de Pneumologie
city: Orléans
country: France
facility: Service de Pneumologie
city: Paris
country: France
facility: Service de Pneumologie
city: Poitiers
country: France
facility: Service de Pneumologie
city: Reims
country: France
facility: Service de Pneumologie
city: Rouen
country: France
facility: Service de Pneumologie
city: Tours
country: France
facility: Service de Pneumologie
Study officials:
affiliation: University Hospital, Tours
name: Patrice DIOT, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: