Contrasting Dosivent With Plus Flow Vu Spacer in Bronchial Hyperreactivity Participants

Bronchial Hyperreactivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05821868
• Other study ID #: 001
• Status: Completed
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: September 2023
• Source: Hospital General Universitario Gregorio Marañon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bronchial Hyperreactivity
• Inhalant Use

Intervention

Device:
• Dosivent
Dosivent® inhalation chamber is designed to optimize the delivery of inhaled bronchodilators and corticosteroids in the treatment of respiratory diseases
• 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

Locations

Country	Name	City	State
Spain	Hospital General Universitario Gregorio Marañon	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Gregorio Marañon

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of bronchodilator response in forced expiratory volume in the first second (FEV1) in miliLiters between Dosivent® and Aerochamber Plus® Flow-Vu® chambers in participants with bronchial hyperreactivity	This study aim is to compare the efficacy, as measured by changes in forced expiratory volume in the first second (FEV1) in mililiters of inhaled Salbutamol with the Dosivent® chamber versus the widely used Aerochamber Plus® Flow-Vu® in participants with a positive Bronchodilator testing.	12 months
Primary	Comparison of bronchodilator response in forced expiratory volume in the first second (FEV1) in percentage between Dosivent® and Aerochamber Plus® Flow-Vu® chambers in participants with bronchial hyperreactivity	This study aim is to compare the efficacy, as measured by changes in forced expiratory volume in the first second (FEV1) in percentage of inhaled salbutamol with the Dosivent® chamber versus the widely used Aerochamber Plus® Flow-Vu® in participants with a positive Bronchodilator testing.	12 months
Secondary	Comparison of bronchodilator response forced vital capacity (FVC) in miliLiters between Dosivent® and Aerochamber Plus® Flow-Vu® chambers in participants with bronchial hyperreactivity	This study aim is to compare the efficacy, as measured by changes in forced vital capacity (FVC) in mililiters,of inhaled Salbutamol with the Dosivent® chamber versus the widely used Aerochamber Plus® Flow-Vu® in participants with a positive Bronchodilator testing.	12 months
Secondary	Comparison of bronchodilator response forced vital capacity (FVC) in percentage between Dosivent® and Aerochamber Plus® Flow-Vu® chambers in participants with bronchial hyperreactivity	This study aim is to compare the efficacy, as measured by changes in forced vital capacity (FVC) in percentage,of inhaled Salbutamol with the Dosivent® chamber versus the widely used Aerochamber Plus® Flow-Vu® in participants with a positive Bronchodilator testing.	12 months