Clinical trial NCT02812979: Evaluation of the Effectiveness of the Nebulization Bronchodilators Under High Nasal Flow Humidified
Official title: Evaluation of the Effectiveness of the Nebulization Bronchodilators Under High Nasal Flow Humidified Compared to a Usual Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2016-06-24
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Increased expiratory volume in one second ( FEV )
timeFrame: measured before and after nebulization of salbutamol at 0 minute and 15 minutes after nebulization of salbutamol
Secondary outcomes:
measure: clinical data (FVC) on the physiological effects of high nasal flow
timeFrame: before and after treatment with humidified high nasal flow at 0 minute and 30 minutes after the treatment with humidified high nasal flow
measure: clinical data (FEV) on the physiological effects of high nasal flow
timeFrame: before and after treatment with humidified high nasal flow at 0 minute and 30 minutes after the treatment with humidified high nasal flow
measure: clinical data (FEV / FVC) on the physiological effects of high nasal flow
timeFrame: before and after treatment with humidified high nasal flow at 0 minute and 30 minutes after the treatment with humidified high nasal flow
Other outcomes:
Locations:
city: Tours
country: France
facility: Service de Réanimation Polyvalente
Study officials:
References: