Contrasting Dosivent With Plus Flow Vu Spacer in Bronchial Hyperreactivity Participants

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bronchial Hyperreactivity, Inhalant Use

Intervention / Treatment
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* Device: Dosivent
* Device: Aerochamber Plus Flow Vu


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aerochamber Plus® Flow-Vu®<br>1. Inhaled space chamber commonly use in our lung function lab for Bronchodilator Testing | Device: Aerochamber Plus Flow Vu<br>* Aerochamber Plus Flow Vu® inhalation chamber is also designed to optimize the delivery of inhaled bronchodilators and corticosteroids in the treatment of respiratory diseases<br>|
| Experimental: Dosivent<br>2. Newer and different inhaled space chamber for Bronchodilator Testing | Device: Dosivent<br>* Dosivent® inhalation chamber is designed to optimize the delivery of inhaled bronchodilators and corticosteroids in the treatment of respiratory diseases<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |