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

Chronic Respiratory Failure Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01958814
• Other study ID #: PHAO11-PD / BANNISTER
• Secondary ID: 2011-004802-20
• Status: Completed
• Phase: Phase 2
• First received: October 7, 2013
• Last updated: May 13, 2016
• Start date: February 2012
• Est. completion date: July 2015

Study information

• Verified date: May 2016
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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 ) .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Respiratory Failure
• Respiratory Insufficiency

Intervention

Drug:
• Salbutamol
First administration of salbutamol or placebo at M0 and 2nd salbutamol or placebo at M60 (or M0 + 60 minutes)
• Placebo
First administration of salbutamol or placebo at M0 and 2nd salbutamol or placebo at M60 (or M0 + 60 minutes)

Locations

Country	Name	City	State
France	Service de Réanimation Médicale - CHR d'Orléans	Orléans
France	Service de Réanimation	Poitiers
France	CHRU de Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collection at the bedside spirometric values		gross change in forced expiratory volume in one second from the beginning of salbutamol or placebo and 15 min after the start	No
Secondary	gross change in vital capacity of peak expiratory flow rate, the ratio of FEV, forced expiratory flow		between the median baseline and 15 min after the start of treatment	No
Secondary	gross change in respiratory rate, heart rate and systolic and diastolic blood pressure		between baseline and 15 min after the start of treatment	No
Secondary	gross change in dyspnea		between baseline and 15 min after the start of treatment	No