NCT05821868

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 20, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

February 22, 2023

Last Update Submit

September 28, 2023

Conditions

Bronchial HyperreactivityInhalant Use

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Comparison of bronchodilator response forced vital capacity (FVC) in miliLiters between Dosivent® and Aerochamber Plus® Flow-Vu® chambers in participants with bronchial hyperreactivity

    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

    12 months

Study Arms (2)

Aerochamber Plus® Flow-Vu®

ACTIVE COMPARATOR

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

Device: Aerochamber Plus Flow Vu

Dosivent

EXPERIMENTAL

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

Device: Dosivent

Interventions

DosiventDEVICE

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

Dosivent
Aerochamber Plus Flow VuDEVICE

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

Aerochamber Plus® Flow-Vu®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

MeSH Terms

Conditions

Bronchial Hyperreactivity

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 22, 2023

First Posted

April 20, 2023

Study Start

July 1, 2022

Primary Completion

July 1, 2023

Study Completion

September 1, 2023

Last Updated

September 29, 2023

Record last verified: 2023-09

Locations

ES(1)