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

Phase 2CompletedNCT01958814

University Hospital, Tours43 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Respiratory Failure

Interventions

SalbutamolDRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Service de Réanimation Médicale - CHR d'Orléans

Orléans, France

Service de Réanimation

Poitiers, France

CHRU de Tours

Tours, France

Outcomes

Primary Outcomes

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

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

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

gross change in dyspnea

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

Data from ClinicalTrials.gov

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