NCT01958814

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: University Hospital, Tours · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 ) .

Conditions

• Chronic Respiratory Failure

Interventions

Type	Name	Description
DRUG	Salbutamol	First administration of salbutamol or placebo at M0 and 2nd salbutamol or placebo at M60 (or M0 + 60 minutes)
DRUG	Placebo	First administration of salbutamol or placebo at M0 and 2nd salbutamol or placebo at M60 (or M0 + 60 minutes)

Timeline

• Start date: 2012-02-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2013-10-09
• Last updated: 2025-12-22

Locations

3 sites across 1 country: France