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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004802-20 | EudraCT Number |
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randomized double-blind controlled study in parallel groups
Salbutamol is a β2 mimetic short-acting to be administered by nebulization in this study.
During this administration, non invasive ventilation for the patient will be continued.
Randomization will focus on the treatment administered (placebo or salbutamol ).
After the first phase , a switch will be set up for each patient , retaining the blind it will be administered salbutamol (for those who received placebo in the first phase ) or placebo (for those receiving salbutamol ) .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Salbutamol - Placebo | Experimental | salbutamol at M0 and M60 placebo administration |
|
| Placebo - Salbutamol | Experimental | placebo at M0 and M60 salbutamol administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salbutamol | Drug | First administration of salbutamol or placebo at M0 and 2nd salbutamol or placebo at M60 (or M0 + 60 minutes) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Collection at the bedside spirometric values | gross change in forced expiratory volume in one second from the beginning of salbutamol or placebo and 15 min after the start |
| Measure | Description | Time Frame |
|---|---|---|
| gross change in vital capacity of peak expiratory flow rate, the ratio of FEV, forced expiratory flow | between the median baseline and 15 min after the start of treatment | |
| gross change in respiratory rate, heart rate and systolic and diastolic blood pressure |
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Inclusion Criteria:
Patient over 18 years old
Patient with BPCO, defined:
Decompensation of this BPCO in the form of acute respiratory failure
No argument for a dominant acute left cardiac insufficiency
Consent signed by the patient
Patient with national health assurance
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre-François DEQUIN, MD-PhD | CHRU de TOURS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Réanimation Médicale - CHR d'Orléans | Orléans | 45000 | France | |||
| Service de Réanimation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30589607 | Result | Bodet-Contentin L, Guillon A, Boulain T, Frat JP, Garot D, Le Pennec D, Vecellio L, Ehrmann S, Giraudeau B, Tavernier E, Dequin PF. Salbutamol Nebulization During Noninvasive Ventilation in Exacerbated Chronic Obstructive Pulmonary Disease Patients: A Randomized Controlled Trial. J Aerosol Med Pulm Drug Deliv. 2019 Jun;32(3):149-155. doi: 10.1089/jamp.2018.1484. Epub 2018 Dec 27. |
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| ID | Term |
|---|---|
| D000420 | Albuterol |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| Placebo | Drug | First administration of salbutamol or placebo at M0 and 2nd salbutamol or placebo at M60 (or M0 + 60 minutes) |
|
|
| between baseline and 15 min after the start of treatment |
| gross change in dyspnea | between baseline and 15 min after the start of treatment |
| Poitiers |
| 86000 |
| France |
| CHRU de Tours | Tours | 37000 | France |
| D000588 |
| Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |