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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Airvo2 with Aerogen Solo
Mask
arm control Airvo2 without nebulization of salbutamol
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service de Réanimation Polyvalente

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Airvo2 with Aerogen Solo

Mask

arm control Airvo2 without nebulization of salbutamol

Arm Description

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

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

control procedure is to be placed under humidified high flow nasal alone

Outcomes

Primary Outcome Measures

Increased expiratory volume in one second ( FEV )

Secondary Outcome Measures

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

Full Information

First Posted
June 16, 2016
Last Updated
May 9, 2018
Sponsor
University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT02812979
Brief Title
Evaluation of the Effectiveness of the Nebulization Bronchodilators Under High Nasal Flow Humidified
Acronym
AirvoNEB
Official Title
Evaluation of the Effectiveness of the Nebulization Bronchodilators Under High Nasal Flow Humidified Compared to a Usual Method
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
April 27, 2018 (Actual)
Study Completion Date
April 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Airvo2 with Aerogen Solo
Arm Type
Experimental
Arm Description
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
Arm Title
Mask
Arm Type
Active Comparator
Arm Description
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
Arm Title
arm control Airvo2 without nebulization of salbutamol
Arm Type
Placebo Comparator
Arm Description
control procedure is to be placed under humidified high flow nasal alone
Intervention Type
Device
Intervention Name(s)
Airvo2 with Aerogen Solo
Other Intervention Name(s)
AirvoNEB
Intervention Description
Nebulization of salbutamol with Airvo 2 and Aerogen solo
Intervention Type
Device
Intervention Name(s)
Mask
Intervention Description
Usual nebulization of salbutamol with mask
Intervention Type
Device
Intervention Name(s)
arm control Airvo2 without nebulization of salbutamol
Intervention Description
Airvo2 with Aerogen Solo. No nebulization of salbutamol
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Service de Réanimation Polyvalente
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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