Recruitment

Recruitment Status
Completed
Estimated Enrollment
180

Inclusion Criteria

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

Exclusion Criteria

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

Summary

Conditions
Severe Chronic Obstructive Pulmonary Disease
Type
Interventional
Phase
Phase 4
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Participant)

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

Inclusion Criteria

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

Exclusion Criteria

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

Tracking Information

NCT #
NCT02103374
Collaborators
Not Provided
Investigators
  • Principal Investigator: Patrice DIOT, MD-PhD University Hospital, Tours
  • Patrice DIOT, MD-PhD University Hospital, Tours