Evaluation of Benefit of Nebulized Bronchodilators at Home in Severe Chronic Obstructive Pulmonary Disease and Very Severe Steady State
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 180
Inclusion Criteria
- COPD Patients stage 3 et 4
- 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
- ...
- COPD Patients stage 3 et 4
- 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
- Patient pre-included not showing exacerbation since the pre-inclusion visit
- Adult
- Has not submitted an exacerbation in the 3 months preceding the pre-inclusion visit
Exclusion Criteria
- Patient under nebulizer or has been treated with nebulized bronchodilators at home over the last 6 months
- Patients with severe cardiovascular disease
- Patient known to be colonized by Pseudomonas aeruginosa, A. xylosoxidans, Burkholderia cepacia or Stenotrophomonas maltophilia
- ...
- Patient under nebulizer or has been treated with nebulized bronchodilators at home over the last 6 months
- Patients with severe cardiovascular disease
- Patient known to be colonized by Pseudomonas aeruginosa, A. xylosoxidans, Burkholderia cepacia or Stenotrophomonas maltophilia
- Patient under non-invasive ventilation (NIV) for less than 6 months or NIV provided in the following year
- Pregnancy
- Progressive malignant disease known
- Patient with an indication of oxygen is expected in the coming 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
- COPD Patients stage 3 et 4
- 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
- ...
- COPD Patients stage 3 et 4
- 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
- Patient pre-included not showing exacerbation since the pre-inclusion visit
- Adult
- Has not submitted an exacerbation in the 3 months preceding the pre-inclusion visit
Exclusion Criteria
- Patient under nebulizer or has been treated with nebulized bronchodilators at home over the last 6 months
- Patients with severe cardiovascular disease
- Patient known to be colonized by Pseudomonas aeruginosa, A. xylosoxidans, Burkholderia cepacia or Stenotrophomonas maltophilia
- ...
- Patient under nebulizer or has been treated with nebulized bronchodilators at home over the last 6 months
- Patients with severe cardiovascular disease
- Patient known to be colonized by Pseudomonas aeruginosa, A. xylosoxidans, Burkholderia cepacia or Stenotrophomonas maltophilia
- Patient under non-invasive ventilation (NIV) for less than 6 months or NIV provided in the following year
- Pregnancy
- Progressive malignant disease known
- Patient with an indication of oxygen is expected in the coming 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
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