Evaluation of the Effectiveness of the Nebulization Bronchodilators Under High Nasal Flow Humidified (AirvoNEB)

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

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).

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: Airvo2 with Aerogen Solo; Device: Mask; Device: arm control Airvo2 without nebulization of salbutamol

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Tours, France, 37044
    • Service de réanimation Polyvalente

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Airvo2 with Aerogen Solo; 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; Nebulization of salbutamol with Airvo 2 and Aerogen solo; Other Names: AirvoNEB
Active Comparator: Mask; 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; Usual nebulization of salbutamol with mask
Placebo Comparator: arm control Airvo2 without nebulization of salbutamol; control procedure is to be placed under humidified high flow nasal alone	Device: arm control Airvo2 without nebulization of salbutamol; Airvo2 with Aerogen Solo. No nebulization of salbutamol

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: University Hospital, Tours

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): April 27, 2018
• Study Completion (Actual): April 27, 2018

Study Registration Dates

• First Submitted: June 16, 2016
• First Submitted That Met QC Criteria: June 23, 2016
• First Posted (Estimate): June 24, 2016

Study Record Updates

• Last Update Posted (Actual): May 15, 2018
• Last Update Submitted That Met QC Criteria: May 9, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Albuterol
• Other Study ID Numbers: PHAO15-SE / AirvoNEB; 2016-A00064-47 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No