Chronic Obstructive Pulmonary Disease
Conditions
Brief summary
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
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.
Interventions
DEVICEAirvo2 with Aerogen Solo
Nebulization of salbutamol with Airvo 2 and Aerogen solo
DEVICEMask
Usual nebulization of salbutamol with mask
DEVICEarm control Airvo2 without nebulization of salbutamol
Airvo2 with Aerogen Solo. No nebulization of salbutamol
Sponsors
University Hospital, Tours
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* adults * Patient with chronic obstructive pulmonary disease * Patients, when performing lung function tests performed outside of the study : 1. A report FEV / FVC less than 60% prior to bronchodilator treatment AND 2. 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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
France
Outcome results
None listed