Evaluation of the Effectiveness of the Nebulization Bronchodilators Under High Nasal Flow Humidified

Study Overview
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Brief Summary
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The principal objective is to show noninferiority of nebulized salbutamol through the high flow nasal system moistened AIRVO ™ 2 in terms of reversibility of airflow obstruction compared to nebulization by the usual method (spray mask).

Detailed Description
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Randomized, comparative, non inferiority study between two nebulization strategies bronchodilators, one according to the method tested namely the spray - in across the top humidified nasal flow system and the other according to a customary procedure, through a mask. A third arm will be evaluated (control arm) to overcome a possible own bronchodilator effect of high flow nasal humidified.

Official Title
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Evaluation of the Effectiveness of the Nebulization Bronchodilators Under High Nasal Flow Humidified Compared to a Usual Method

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: Airvo2 with Aerogen Solo
* Device: Mask
* Device: arm control Airvo2 without nebulization of salbutamol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults Patient with chronic obstructive pulmonary disease Patients, when performing lung function tests performed outside of the study : A report FEV / FVC less than 60% prior to bronchodilator treatment AND A positive reversal test defined by FEV variation of over 12 % and 200 mL after administration of inhaled salbutamol Patients affiliated to social security scheme Informed consent signed by the patient Exclusion Criteria: Exacerbation of chronic obstructive pulmonary disease during Uncontrolled asthma Pneumothorax current or recent ( < 2 months) Pleural aspiration or biopsy , trans - bronchial biopsies and / or bronchoalveolar lavage in the preceding 48h hemoptysis in progress Patient under guardianship or trusteeship safeguard justice Pregnant or breastfeeding women or parturient woman Known allergy or intolerance to salbutamol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Airvo2 with Aerogen Solo<br>AIRVOTM2 will be set to deliver air (21% oxygen concentration ) at a rate of 30 L / min at 100 % relative humidity at 37 ° C. Nebulization of salbutamol will be effected by means of a nebulizer to the vibrating screen (Aerogen® Solo, Aerogen , Galway, Ireland ) which is a nebulizing device for single use, commonly used in invasive and non invasive mechanical ventilation. Nebulizer will be responsible for a salbutamol solution available in the form of containers of 2.5 ml containing 2.5 mg of salbutamol | Device: Airvo2 with Aerogen Solo<br>* Nebulization of salbutamol with Airvo 2 and Aerogen solo<br>* Other names: AirvoNEB;|
| Active Comparator: Mask<br>During nebulization in the usual way ( oral facial mask ) , it will be used a pneumatic nebulizer powered by a 6 L / min air flow rate ( usual method ). Nebulizer will be responsible for a salbutamol solution available in the form of containers of 2.5 ml containing 2.5 mg of salbutamol | Device: Mask<br>* Usual nebulization of salbutamol with mask<br>|
| Placebo Comparator: arm control Airvo2 without nebulization of salbutamol<br>control procedure is to be placed under humidified high flow nasal alone | Device: arm control Airvo2 without nebulization of salbutamol<br>* Airvo2 with Aerogen Solo. No nebulization of salbutamol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increased expiratory volume in one second ( FEV ) |  | measured before and after nebulization of salbutamol at 0 minute and 15 minutes after nebulization of salbutamol | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical data (FVC) on the physiological effects of high nasal flow |  | before and after treatment with humidified high nasal flow at 0 minute and 30 minutes after the treatment with humidified high nasal flow | 
| clinical data (FEV) on the physiological effects of high nasal flow |  | before and after treatment with humidified high nasal flow at 0 minute and 30 minutes after the treatment with humidified high nasal flow | 
| clinical data (FEV / FVC) on the physiological effects of high nasal flow |  | before and after treatment with humidified high nasal flow at 0 minute and 30 minutes after the treatment with humidified high nasal flow |