Evaluation of Benefit of Nebulized Bronchodilators at Home in Severe Chronic Obstructive Pulmonary Disease and Very Severe Steady State
NCT ID: NCT02103374
Last Updated: 2016-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
45 participants
INTERVENTIONAL
2012-01-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SINGLE
Study Groups
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Atrovent + Bricanyl or Atrovent + Ventolin
3 daily inhalations of Atrovent mixture to form Bricanyl or Ventolin form Atrovent 0,5mg/1ml Bricanyl 5mg/2ml Ventolin 5mg/2,5ml
Atrovent + Bricanyl or Atrovent + Ventoline
3 daily inhalations of Atrovent mixture to form Bricanyl or Ventolin form during 48 weeks
Placebo
1 capsule per day lactose (in addition to the standard optimized treatment)
Placebo
1 capsule lactose during 48 weeks
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
80 Years
ALL
No
Sponsors
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University Hospital, Tours
OTHER
Responsible Party
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Principal Investigators
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Patrice DIOT, MD-PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Tours
Locations
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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, , France
Countries
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Other Identifiers
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2010-023743-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2010-R38
Identifier Type: OTHER
Identifier Source: secondary_id
A101466-30
Identifier Type: OTHER
Identifier Source: secondary_id
PHRN10-PD/Nebuadom
Identifier Type: -
Identifier Source: org_study_id
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