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Completed

NCT Number: NCT02812979

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

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).

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Réanimation Polyvalente

Tours, 37044, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Airvo2 with Aerogen Solo

Device

Nebulization of salbutamol with Airvo 2 and Aerogen solo

Other names: AirvoNEB

Mask

Device

Usual nebulization of salbutamol with mask

arm control Airvo2 without nebulization of salbutamol

Device

Airvo2 with Aerogen Solo. No nebulization of salbutamol

Primary outcomes

  1. Increased expiratory volume in one second ( FEV )

    Time frame: measured before and after nebulization of salbutamol at 0 minute and 15 minutes after nebulization of salbutamol

Secondary outcomes

  1. clinical data (FVC) on the physiological effects of high nasal flow

    Time frame: before and after treatment with humidified high nasal flow at 0 minute and 30 minutes after the treatment with humidified high nasal flow

  2. clinical data (FEV) on the physiological effects of high nasal flow

    Time frame: before and after treatment with humidified high nasal flow at 0 minute and 30 minutes after the treatment with humidified high nasal flow

  3. clinical data (FEV / FVC) on the physiological effects of high nasal flow

    Time frame: before and after treatment with humidified high nasal flow at 0 minute and 30 minutes after the treatment with humidified high nasal flow

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

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

Acronym: AirvoNEB

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 24, 2016
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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