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

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ClinicalTrials.gov Identifier: NCT02812979
Recruitment Status : Completed
First Posted : June 24, 2016
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours

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).

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Device: Airvo2 with Aerogen Solo Device: Mask Device: arm control Airvo2 without nebulization of salbutamol Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of the Effectiveness of the Nebulization Bronchodilators Under High Nasal Flow Humidified Compared to a Usual Method
Study Start Date : June 2016
Actual Primary Completion Date : April 27, 2018
Actual Study Completion Date : April 27, 2018

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812979


Locations
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France
Service de Réanimation Polyvalente
Tours, France, 37044
Sponsors and Collaborators
University Hospital, Tours
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Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT02812979    
Other Study ID Numbers: PHAO15-SE / AirvoNEB
2016-A00064-47 ( Other Identifier: ID RCB )
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action