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

May 13, 2016 updated by: University Hospital, Tours

Controlled Randomized Double-blind Study Comparing Salbutamol and Placebo Via Aerosol in Chronic Obstructive Respiratory Insufficiency in Exacerbartion Treated With Noninvasive Ventilation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 ) .

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Orléans, France, 45000
        • Service de Réanimation Médicale - CHR d'Orléans
      • Poitiers, France, 86000
        • Service de réanimation
      • Tours, France, 37000
        • CHRU de Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Salbutamol - Placebo
salbutamol at M0 and M60 placebo administration
Drug: Salbutamol
First administration of salbutamol or placebo at M0 and 2nd salbutamol or placebo at M60 (or M0 + 60 minutes)
Other Names:
  • Treatment
Drug: Placebo
First administration of salbutamol or placebo at M0 and 2nd salbutamol or placebo at M60 (or M0 + 60 minutes)
Other Names:
  • physiological serum
Experimental: Placebo - Salbutamol
placebo at M0 and M60 salbutamol administration
Drug: Salbutamol
First administration of salbutamol or placebo at M0 and 2nd salbutamol or placebo at M60 (or M0 + 60 minutes)
Other Names:
  • Treatment
Drug: Placebo
First administration of salbutamol or placebo at M0 and 2nd salbutamol or placebo at M60 (or M0 + 60 minutes)
Other Names:
  • physiological serum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
gross change in forced expiratory volume in one second from the beginning of salbutamol or placebo and 15 min after the start

Secondary Outcome Measures

Outcome Measure
Time Frame
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
between the median baseline and 15 min after the start of treatment
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
between baseline and 15 min after the start of treatment
gross change in dyspnea
Time Frame: between baseline and 15 min after the start of treatment
between baseline and 15 min after the start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Investigators

  • Principal Investigator: Pierre-François DEQUIN, MD-PhD, CHRU de Tours

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

October 7, 2013

First Submitted That Met QC Criteria

October 8, 2013

First Posted (Estimate)

October 9, 2013

Study Record Updates

Last Update Posted (Estimate)

May 16, 2016

Last Update Submitted That Met QC Criteria

May 13, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHAO11-PD / BANNISTER
  • 2011-004802-20 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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