Beta Agonist Nebulization in Non Invasively Ventilated COPD Patients: Safety, and Therapeutic Efficacy Range.

Study Overview
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Brief Summary
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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.

Detailed Description
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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 ) .

Official Title
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Controlled Randomized Double-blind Study Comparing Salbutamol and Placebo Via Aerosol in Chronic Obstructive Respiratory Insufficiency in Exacerbartion Treated With Noninvasive Ventilation

Conditions
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Chronic Respiratory Failure

Intervention / Treatment
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* Drug: Salbutamol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient over 18 years old Patient with BPCO, defined: by an irreversible obstructive syndrome and\or by different arguments (histories, symptoms, physical examination, thoracic radiography, gas of the blood) 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: Contraindications in the not invasive ventilation Patient not volunteer for the realization of the spirometry Precautions for use of ß2 mimetic (engrave hyperthyroidism) Under guardianship patient or protection of justice Pregnant patient

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Salbutamol - Placebo<br>salbutamol at M0 and M60 placebo administration | Drug: Salbutamol<br>* First administration of salbutamol or placebo at M0 and 2nd salbutamol or placebo at M60 (or M0 + 60 minutes)<br>* Other names: Treatment;Drug: Placebo<br>* First administration of salbutamol or placebo at M0 and 2nd salbutamol or placebo at M60 (or M0 + 60 minutes)<br>* Other names: physiological serum;|
| Experimental: Placebo - Salbutamol<br>placebo at M0 and M60 salbutamol administration | Drug: Salbutamol<br>* First administration of salbutamol or placebo at M0 and 2nd salbutamol or placebo at M60 (or M0 + 60 minutes)<br>* Other names: Treatment;Drug: Placebo<br>* First administration of salbutamol or placebo at M0 and 2nd salbutamol or placebo at M60 (or M0 + 60 minutes)<br>* Other names: physiological serum;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | between baseline and 15 min after the start of treatment | 
| gross change in dyspnea |  | between baseline and 15 min after the start of treatment |