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

Severe Chronic Obstructive Pulmonary Disease Clinical Trial

— Nebuadom  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02103374
• Other study ID #: PHRN10-PD/Nebuadom
• Secondary ID: 2010-023743-1420
• Status: Completed
• Phase: Phase 4
• First received: March 12, 2014
• Last updated: April 26, 2016
• Start date: January 2012
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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 ...).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Severe Chronic Obstructive Pulmonary Disease

Intervention

Drug:
• Atrovent + Bricanyl or Atrovent + Ventoline
3 daily inhalations of Atrovent mixture to form Bricanyl or Ventolin form during 48 weeks
• Placebo
1 capsule lactose during 48 weeks

Locations

Country	Name	City	State
France	Service de Pneumologie	Amiens
France	Service de Pneumologie	Angers
France	Service de Pneumologie	Brest
France	Service de Pneumologie	Grenoble
France	Service de Pneumologie	Limoges
France	Service de Pneumologie	Nancy
France	Service de Pneumologie	Nantes
France	Service de Pneumologie	Orléans
France	Service de Pneumologie	Paris
France	Service de Pneumologie	Poitiers
France	Service de Pneumologie	Reims
France	Service de Pneumologie	Rouen
France	Service de Pneumologie	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of exacerbations		Patients will be followed for the duration of their participation ie 48 weeks	Yes
Other	Number of hospitalizations		Patients will be followed for the duration of their participation ie 48 weeks	Yes
Primary	Score for quality of life, assessed by the questionnaire St Georges		Patients will be followed for the duration of their participation ie 48 weeks	No
Secondary	Score for quality of life, assessed by the questionnaire VQ11		Patients will be followed for the duration of their participation ie 48 weeks	No
Secondary	Dyspnea score according Medical Research Council		Patients will be followed for the duration of their participation ie 48 weeks	No
Secondary	Prognostic Score Mortality assessed by the score BODE		Patients will be followed for the duration of their participation ie 48 weeks	No