NCT05821868

Contrasting Dosivent With Plus Flow Vu Spacer in Bronchial Hyperreactivity Participants

Contrasting Dosivent Spacer Device With Plus Flow Vu Spacer in Bronchial Hyperreactivity Participants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Hospital General Universitario Gregorio Marañon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study aims to compare the efficacy, as measured by changes in forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC), of salbutamol inhaled with the Dosivent® chamber versus the widely used Aerochamber Plus® Flow-Vu® in participants with a positive bronchodilator testing.

Detailed description

The investigators are conducting a non-randomized, open-label, crossover-controlled clinical trial in 50 participants with a previous positive bronchodilation testing. The protocol was approved by the local clinical ethics committee (code 03/2022). All participants provided written informed consent before any study procedure. During the study, the principles of the Declaration of Helsinki and the current standards of Good Clinical Practice were followed. Participants over 18 years of age are included who attended our center for a bronchodilator test, gave a positive result in this test, and provided written informed consent for participation in this study. Participants are excluded if grade A quality spirometry was not obtained according to the classification in current regulations and, in the opinion of the investigator, performing a bronchodilator test could pose a risk to the participant or interrupting the usual bronchodilator treatment could worsen the underlying respiratory pathology.

Conditions

• Bronchial Hyperreactivity
• Inhalant Use

Interventions

Type	Name	Description
DEVICE	Dosivent	Dosivent® inhalation chamber is designed to optimize the delivery of inhaled bronchodilators and corticosteroids in the treatment of respiratory diseases
DEVICE	Aerochamber Plus Flow Vu	Aerochamber Plus Flow Vu® inhalation chamber is also designed to optimize the delivery of inhaled bronchodilators and corticosteroids in the treatment of respiratory diseases

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-07-01
• Completion: 2023-09-01
• First posted: 2023-04-20
• Last updated: 2023-09-29

Locations

1 site across 1 country: Spain