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Completed

NCT Number: NCT01958814

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Service de Réanimation Médicale - CHR d'Orléans, Orléans, France

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About this study

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 ) .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Salbutamol

Drug

First administration of salbutamol or placebo at M0 and 2nd salbutamol or placebo at M60 (or M0 + 60 minutes)

Other names: Treatment

Placebo

Drug

First administration of salbutamol or placebo at M0 and 2nd salbutamol or placebo at M60 (or M0 + 60 minutes)

Other names: physiological serum

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. gross change in dyspnea

    Time frame: between baseline and 15 min after the start of treatment

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

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

Acronym: BANNISTER

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 9, 2013
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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