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High-flow Nasal Cannula Nebulization of Beta 2 Adrenergic Agonist During Acute Exacerbation of Chronic Obstructive Pulmonary Disease (OPTINEB)

Primary Purpose

Chronic Obstructive Pulmonary Disease, High-flow Nasal Cannula

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
salbutamol
Sponsored by
Poitiers University Hospital
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 - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Arterial pH over 7.25,
  • Respiratory rate under 35 breaths/mn
  • Glasgow Coma Scale equal to 15,
  • indication of beta-2 agonist nebulization less than 8 per day (time between two nebulization more than 3 hours),
  • NIV sessions spaced more than 6 hours.

Exclusion Criteria:

  • Urgent endotracheal intubation;
  • Contraindication to beta 2 adrenergic agonist;
  • Another organ failure (hemodynamic and neurological instability);
  • Cardioselective beta-blocker during treatment of copd exacerbation;

Sites / Locations

  • C.H.U. de PoitiersRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TREATMENT

Arm Description

salbutamol nebulization

Outcomes

Primary Outcome Measures

compare lung functions
Evolution of Forced Expiratory Volume 1s

Secondary Outcome Measures

Full Information

First Posted
January 12, 2018
Last Updated
February 11, 2019
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03449056
Brief Title
High-flow Nasal Cannula Nebulization of Beta 2 Adrenergic Agonist During Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Acronym
OPTINEB
Official Title
High-flow Nasal Cannula Nebulization of Beta 2 Adrenergic Agonist During Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 11, 2019 (Actual)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
April 2020 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
High-flow nasal cannula is an oxygenation technique increasingly used for patients admitted for acute respiratory failure. Literature essentially concerns "de novo" acute hypoxemic failure and the interest of high-flow during take care of chronic obstructive pulmonary disease patients is few studied. Physiological studies reported potential benefits of high-flow nasal cannula oxygenation in chronic obstructive pulmonary disease patients including dead space clearance and decrease of respiratory, which lead to decrease work of breathing. As inhaled bronchodilators are part of treatment of chronic obstructive pulmonary disease exacerbation, nebulization could be also provided through high-flow nasal cannula oxygen therapy. The aim of our study is to determine whether a beta-2 agonist nebulization administered through High-flow nasal cannula is efficient to improve spirometry of patients for admitted hronic obstructive pulmonary disease exacerbation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, High-flow Nasal Cannula

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TREATMENT
Arm Type
Experimental
Arm Description
salbutamol nebulization
Intervention Type
Drug
Intervention Name(s)
salbutamol
Intervention Description
T2 - T1+1h30: High-nasal flow and salbutamol nebulization
Primary Outcome Measure Information:
Title
compare lung functions
Description
Evolution of Forced Expiratory Volume 1s
Time Frame
baseline-1h30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Arterial pH over 7.25, Respiratory rate under 35 breaths/mn Glasgow Coma Scale equal to 15, indication of beta-2 agonist nebulization less than 8 per day (time between two nebulization more than 3 hours), NIV sessions spaced more than 6 hours. Exclusion Criteria: Urgent endotracheal intubation; Contraindication to beta 2 adrenergic agonist; Another organ failure (hemodynamic and neurological instability); Cardioselective beta-blocker during treatment of copd exacerbation;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Pierre FRAT
Phone
+33549442830
Email
jean-pierre.frat@chu-poitiers.fr
First Name & Middle Initial & Last Name or Official Title & Degree
nicolas MARJANOVIC
Email
nicolas.marjanovic@chu-poitiers.fr
Facility Information:
Facility Name
C.H.U. de Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre Frat, MD
Email
jean-pierre.frat@chu-poitiers.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

High-flow Nasal Cannula Nebulization of Beta 2 Adrenergic Agonist During Acute Exacerbation of Chronic Obstructive Pulmonary Disease

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