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Beta Agonist Nebulization in Non Invasively Ventilated COPD Patients: Safety, and Therapeutic Efficacy Range. (BANNISTER)

Primary Purpose

Chronic Respiratory Failure

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Salbutamol
Placebo
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Respiratory Failure

Eligibility Criteria

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

Inclusion Criteria:

  • Patient over 18 years old

  • Patient with BPCO, defined:

    • by an irreversible obstructive syndrome
    • and\or by different arguments (histories, symptoms, physical examination, thoracic radiography, gas of the blood)
  • Decompensation of this BPCO in the form of acute respiratory failure
  • No argument for a dominant acute left cardiac insufficiency
  • Consent signed by the patient
  • Patient with national health assurance

Exclusion Criteria:

  • Contraindications in the not invasive ventilation
  • Patient not volunteer for the realization of the spirometry
  • Precautions for use of ß2 mimetic (engrave hyperthyroidism)
  • Under guardianship patient or protection of justice
  • Pregnant patient

Sites / Locations

  • Service de Réanimation Médicale - CHR d'Orléans
  • Service de Réanimation
  • CHRU de Tours

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Salbutamol - Placebo

Placebo - Salbutamol

Arm Description

salbutamol at M0 and M60 placebo administration

placebo at M0 and M60 salbutamol administration

Outcomes

Primary Outcome Measures

Collection at the bedside spirometric values

Secondary Outcome Measures

gross change in vital capacity of peak expiratory flow rate, the ratio of FEV, forced expiratory flow
gross change in respiratory rate, heart rate and systolic and diastolic blood pressure
gross change in dyspnea

Full Information

First Posted
October 7, 2013
Last Updated
May 13, 2016
Sponsor
University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT01958814
Brief Title
Beta Agonist Nebulization in Non Invasively Ventilated COPD Patients: Safety, and Therapeutic Efficacy Range.
Acronym
BANNISTER
Official Title
Controlled Randomized Double-blind Study Comparing Salbutamol and Placebo Via Aerosol in Chronic Obstructive Respiratory Insufficiency in Exacerbartion Treated With Noninvasive Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (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
randomized double-blind controlled study in parallel groups Salbutamol is a β2 mimetic short-acting to be administered by nebulization in this study. During this administration, non invasive ventilation for the patient will be continued.
Detailed Description
Randomization will focus on the treatment administered (placebo or salbutamol ). After the first phase , a switch will be set up for each patient , retaining the blind it will be administered salbutamol (for those who received placebo in the first phase ) or placebo (for those receiving salbutamol ) .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Respiratory Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Salbutamol - Placebo
Arm Type
Experimental
Arm Description
salbutamol at M0 and M60 placebo administration
Arm Title
Placebo - Salbutamol
Arm Type
Experimental
Arm Description
placebo at M0 and M60 salbutamol administration
Intervention Type
Drug
Intervention Name(s)
Salbutamol
Other Intervention Name(s)
Treatment
Intervention Description
First administration of salbutamol or placebo at M0 and 2nd salbutamol or placebo at M60 (or M0 + 60 minutes)
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
physiological serum
Intervention Description
First administration of salbutamol or placebo at M0 and 2nd salbutamol or placebo at M60 (or M0 + 60 minutes)
Primary Outcome Measure Information:
Title
Collection at the bedside spirometric values
Time Frame
gross change in forced expiratory volume in one second from the beginning of salbutamol or placebo and 15 min after the start
Secondary Outcome Measure Information:
Title
gross change in vital capacity of peak expiratory flow rate, the ratio of FEV, forced expiratory flow
Time Frame
between the median baseline and 15 min after the start of treatment
Title
gross change in respiratory rate, heart rate and systolic and diastolic blood pressure
Time Frame
between baseline and 15 min after the start of treatment
Title
gross change in dyspnea
Time Frame
between baseline and 15 min after the start of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient over 18 years old Patient with BPCO, defined: by an irreversible obstructive syndrome and\or by different arguments (histories, symptoms, physical examination, thoracic radiography, gas of the blood) Decompensation of this BPCO in the form of acute respiratory failure No argument for a dominant acute left cardiac insufficiency Consent signed by the patient Patient with national health assurance Exclusion Criteria: Contraindications in the not invasive ventilation Patient not volunteer for the realization of the spirometry Precautions for use of ß2 mimetic (engrave hyperthyroidism) Under guardianship patient or protection of justice Pregnant patient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre-François DEQUIN, MD-PhD
Organizational Affiliation
CHRU de TOURS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Réanimation Médicale - CHR d'Orléans
City
Orléans
ZIP/Postal Code
45000
Country
France
Facility Name
Service de Réanimation
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
CHRU de Tours
City
Tours
ZIP/Postal Code
37000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30589607
Citation
Bodet-Contentin L, Guillon A, Boulain T, Frat JP, Garot D, Le Pennec D, Vecellio L, Ehrmann S, Giraudeau B, Tavernier E, Dequin PF. Salbutamol Nebulization During Noninvasive Ventilation in Exacerbated Chronic Obstructive Pulmonary Disease Patients: A Randomized Controlled Trial. J Aerosol Med Pulm Drug Deliv. 2019 Jun;32(3):149-155. doi: 10.1089/jamp.2018.1484. Epub 2018 Dec 27.
Results Reference
derived

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Beta Agonist Nebulization in Non Invasively Ventilated COPD Patients: Safety, and Therapeutic Efficacy Range.

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