Contrasting Dosivent With Plus Flow Vu Spacer in Bronchial Hyperreactivity Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-09-01

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.

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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.

Conditions

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Bronchial Hyperreactivity Inhalant Use

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Aerochamber Plus® Flow-Vu®

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

Group Type ACTIVE_COMPARATOR

Aerochamber Plus Flow Vu

Intervention Type DEVICE

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

Dosivent

2\. Newer and different inhaled space chamber for Bronchodilator Testing

Group Type EXPERIMENTAL

Dosivent

Intervention Type DEVICE

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

Interventions

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Dosivent

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

Intervention Type 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

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes