Bronchial HyperreactivityNCT05821868
Contrasting Dosivent With Plus Flow Vu Spacer in Bronchial Hyperreactivity Participants
A study testing Dosivent and Aerochamber Plus Flow Vu in people with Bronchial Hyperreactivity and Inhalant Use, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bronchial Hyperreactivity, Inhalant Use
- What is being tested?
- Dosivent and Aerochamber Plus Flow Vu
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2022to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Contrasting Dosivent Spacer Device With Plus Flow Vu Spacer in Bronchial Hyperreactivity Participants
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.
Read the detailed 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.
- Conditions
- Bronchial Hyperreactivity, Inhalant Use
- Being tested
- Dosivent, Aerochamber Plus Flow Vu
- Medical subject headings
- Bronchial Hyperreactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DosiventDevice
Dosivent® inhalation chamber is designed to optimize the delivery of inhaled bronchodilators and corticosteroids in the treatment of respiratory diseases
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
| Study group | Role | What they receive |
|---|---|---|
| Aerochamber Plus® Flow-Vu® | Active comparator | 1. Inhaled space chamber commonly use in our lung function lab for Bronchodilator Testing Receives: Device: Aerochamber Plus Flow Vu |
| Dosivent | Experimental | 2. Newer and different inhaled space chamber for Bronchodilator Testing Receives: Device: Dosivent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start1 Jul 2022
- Primary completion1 Jul 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial HyperreactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Puente Maestu, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821868
- Sponsor's protocol ID
- 001
- Status last verified
- Sep 2023
- First submitted
- 22 Feb 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrasting Dosivent Spacer Device With Plus Flow Vu Spacer in Bronchial Hyperreactivity Participants
- ClinicalTrials.gov ID
- NCT05821868
- Acronym / sponsor ID
- 001
- Conditions
- Bronchial Hyperreactivity, Inhalant Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerochamber Plus® Flow-Vu® | Active comparator | Device: Aerochamber Plus Flow Vu1. Inhaled space chamber commonly use in our lung function lab for Bronchodilator Testing |
| Dosivent | Experimental | Device: Dosivent2. Newer and different inhaled space chamber for Bronchodilator Testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DosiventDosivent® inhalation chamber is designed to optimize the delivery of inhaled bronchodilators and corticosteroids in the treatment of respiratory diseases | Device | Dosivent |
| Aerochamber Plus Flow VuAerochamber Plus Flow Vu® inhalation chamber is also designed to optimize the delivery of inhaled bronchodilators and corticosteroids in the treatment of respiratory diseases | Device | Aerochamber Plus® Flow-Vu® |
Primary outcome
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
Time frame: 12 months
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.
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
Time frame: 12 months
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.
2 secondary outcomes
Comparison of bronchodilator response forced vital capacity (FVC) in miliLiters between Dosivent® and Aerochamber Plus® Flow-Vu® chambers in participants with bronchial hyperreactivity
Time frame: 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
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dosivent and Aerochamber Plus Flow Vu in people with Bronchial Hyperreactivity and Inhalant Use, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.