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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023743-14 | EudraCT Number | ||
| 2010-R38 | Other Identifier | CPP | |
| A101466-30 | Other Identifier | Afssaps |
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Design studies of nebulization in COPD does not respond adequately to the clinically relevant question: the intervention of administering nebulized bronchodilators at home it is likely to make a profit, compared to the standard optimized treatment as defined by the recommendations of the SPLF, patients with severe COPD (stage III, FEV between 30% and 50% of the theoretical value) and very severe (stage IV, less than 30% of the theoretical value FEV)? The concept of profit in this context is based on criteria of dyspnea, quality of life, use of health system (exacerbations, hospitalizations, prescription of antibiotics and steroids ...).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atrovent + Bricanyl or Atrovent + Ventolin | Experimental | 3 daily inhalations of Atrovent mixture to form Bricanyl or Ventolin form Atrovent 0,5mg/1ml Bricanyl 5mg/2ml Ventolin 5mg/2,5ml |
|
| Placebo | Placebo Comparator | 1 capsule per day lactose (in addition to the standard optimized treatment) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atrovent + Bricanyl or Atrovent + Ventoline | Drug | 3 daily inhalations of Atrovent mixture to form Bricanyl or Ventolin form during 48 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Score for quality of life, assessed by the questionnaire St Georges | Patients will be followed for the duration of their participation ie 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Score for quality of life, assessed by the questionnaire VQ11 | Patients will be followed for the duration of their participation ie 48 weeks | |
| Dyspnea score according Medical Research Council | Patients will be followed for the duration of their participation ie 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of exacerbations | Patients will be followed for the duration of their participation ie 48 weeks | |
| Number of hospitalizations | Patients will be followed for the duration of their participation ie 48 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrice DIOT, MD-PhD | University Hospital, Tours | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Pneumologie | Amiens | 80054 | France | |||
| Service de Pneumologie |
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| Placebo | Drug | 1 capsule lactose during 48 weeks |
|
| Prognostic Score Mortality assessed by the score BODE | Patients will be followed for the duration of their participation ie 48 weeks |
| Angers |
| 49033 |
| France |
| Service de Pneumologie | Brest | 29609 | France |
| Service de Pneumologie | Grenoble | 38043 | France |
| Service de Pneumologie | Limoges | 87042 | France |
| Service de Pneumologie | Nancy | 54511 | France |
| Service de Pneumologie | Nantes | 44093 | France |
| Service de Pneumologie | Orléans | 45067 | France |
| Service de Pneumologie | Paris | 75004 | France |
| Service de Pneumologie | Poitiers | 86000 | France |
| Service de Pneumologie | Reims | 51100 | France |
| Service de Pneumologie | Rouen | 76031 | France |
| Service de Pneumologie | Tours | 37044 | France |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009241 | Ipratropium |
| D013726 | Terbutaline |
| ID | Term |
|---|---|
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D000588 | Amines |
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