Contrasting Dosivent With Plus Flow Vu Spacer in Bronchial Hyperreactivity Participants

Hospital General Universitario Gregorio Marañon

Status: Completed

Conditions: Bronchial Hyperreactivity; Inhalant Use

Treatments: Device: Aerochamber Plus Flow Vu; Device: Dosivent

Study type: Interventional

Funder types: Other

Identifiers

NCT05821868

001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants over 18 years of age
• Attending our center for a bronchodilator test
• Positive bronchodilator result with increase of Forced Expiratory Volume in first second greater than 200 mililiters and 12%
• Provided written informed consent for participation in this study

Exclusion criteria

• Grade A quality spirometry was not obtained according to the classification in current regulation
• Performing a bronchodilator test, in the opinion of the investigator, could pose a risk to the participant or interrupting the usual bronchodilator treatment could worsen the underlying respiratory pathology.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Aerochamber Plus® Flow-Vu®

Active Comparator group

Description:

1. Inhaled space chamber commonly use in our lung function lab for Bronchodilator Testing

Treatment:

Device: Aerochamber Plus Flow Vu

Dosivent

Experimental group

Description:

2. Newer and different inhaled space chamber for Bronchodilator Testing

Treatment:

Device: Dosivent