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

Chronic Obstructive Pulmonary Disease Clinical Trial

— AirvoNEB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02812979
• Other study ID #: PHAO15-SE / AirvoNEB
• Secondary ID: 2016-A00064-47
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: April 27, 2018

Study information

• Verified date: May 2018
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 27, 2018
• Est. primary completion date: April 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Airvo2 with Aerogen Solo
Nebulization of salbutamol with Airvo 2 and Aerogen solo
• Mask
Usual nebulization of salbutamol with mask
• arm control Airvo2 without nebulization of salbutamol
Airvo2 with Aerogen Solo. No nebulization of salbutamol

Locations

Country	Name	City	State
France	Service de Réanimation Polyvalente	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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