Recruitment

Recruitment Status
Completed
Estimated Enrollment
180

Inclusion Criteria

Weaned from tobacco for at least 6 months
Has not submitted an exacerbation in the 3 months preceding 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
Has not submitted an exacerbation in the 3 months preceding the pre-inclusion visit
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
vaccinated against pneumococcal
Adult
COPD Patients stage 3 et 4

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 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
Pregnancy
Patient known to be colonized by Pseudomonas aeruginosa, A. xylosoxidans, Burkholderia cepacia or Stenotrophomonas maltophilia
Patients with severe cardiovascular disease
Patient under non-invasive ventilation (NIV) for less than 6 months or NIV provided in the following year

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

Weaned from tobacco for at least 6 months
Has not submitted an exacerbation in the 3 months preceding 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
Has not submitted an exacerbation in the 3 months preceding the pre-inclusion visit
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
vaccinated against pneumococcal
Adult
COPD Patients stage 3 et 4

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 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
Pregnancy
Patient known to be colonized by Pseudomonas aeruginosa, A. xylosoxidans, Burkholderia cepacia or Stenotrophomonas maltophilia
Patients with severe cardiovascular disease
Patient under non-invasive ventilation (NIV) for less than 6 months or NIV provided in the following year

Tracking Information

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