Recruitment

Recruitment Status
Completed
Estimated Enrollment
180

Inclusion Criteria

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

Exclusion Criteria

Progressive malignant disease known
Pregnancy
Patient under nebulizer or has been treated with nebulized bronchodilators at home over the last 6 months
...
Progressive malignant disease known
Pregnancy
Patient under nebulizer or has been treated with nebulized bronchodilators at home over the last 6 months
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
Patients with severe cardiovascular disease

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

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

Exclusion Criteria

Progressive malignant disease known
Pregnancy
Patient under nebulizer or has been treated with nebulized bronchodilators at home over the last 6 months
...
Progressive malignant disease known
Pregnancy
Patient under nebulizer or has been treated with nebulized bronchodilators at home over the last 6 months
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
Patients with severe cardiovascular disease

Locations

Nantes, 44093
Limoges, 87042
Brest, 29609
Paris, 75004
Angers, 49033
...
Nantes, 44093
Limoges, 87042
Brest, 29609
Paris, 75004
Angers, 49033
Nancy, 54511
Poitiers, 86000
Amiens, 80054
Grenoble, 38043
Tours, 37044
Rouen, 76031
Reims, 51100
Orléans, 45067

Tracking Information

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