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

Regional University Hospital Center (CHRU)

Status and phase: Completed; Phase 2

Conditions: Chronic Respiratory Failure

Treatments: Drug: Salbutamol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01958814

PHAO11-PD / BANNISTER

2011-004802-20 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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 ) .

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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43 participants in 2 patient groups

Salbutamol - Placebo

Experimental group

Description:

salbutamol at M0 and M60 placebo administration

Treatment:

Drug: Placebo

Drug: Salbutamol

Placebo - Salbutamol

Experimental group

Description:

placebo at M0 and M60 salbutamol administration

Treatment:

Drug: Placebo

Drug: Salbutamol