AsthmaNCT06502405
Research on the Application of Electrical Impedance Tomography in Bronchial Challenge Testing
An observational study of Asthma, run by wang kaifei.
Trial summary
The purpose of this study was to examine whether electrical impedance tomography (EIT) was capable of identifying the deteriorated lung function on a regional level during bronchial challenge testing and whether EIT may provide additional information during bronchial challenge testing and identify spatial and temporal… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 30 Jun 2025
- Phase
- Observational
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients need to exclude or confirm a suspected diagnosis of asthma through bronchial challenge testing.
Who may be able to join
- Patients suspected of asthma who require bronchial challenge testing.
- The Bronchodilator responsiveness testing is negative.
- patients with a pre-bronchodilator FEV1 >60% predicted.
- No contraindications for bronchial provocation test examination.
- Fully understand the purpose and significance of this study, and voluntarily participate in the research.
Who cannot join
- 1. patients with a pre-bronchodilator FEV1≤60% predicted.
- Contraindications for bronchial challenge testing.
- Pregnant or lactating women.
- After pacemaker surgery.
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this study was to examine whether electrical impedance tomography (EIT) was capable of identifying the deteriorated lung function on a regional level during bronchial challenge testing and whether EIT may provide additional information during bronchial challenge testing and identify spatial and temporal heterogeneity of regional lung function.
Read the detailed description
The content of this study includes:
- Can EIT identify the uneven ventilation caused by airway contraction in patients during bronchial provocation tests.
- Can EIT monitor airway contraction in patients before Spirometer examination after inhaling activators.
- Can EIT observe uneven ventilation caused by airway contraction through tidal breathing after the patient inhales activator.
- Conditions
- Asthma
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
global inhomogeneity index （GI）
Measured by EIT, used to describe the overall degree of spatial heterogeneity of ventilation.
Measured: 1day
forced expiratory volume in 1s (FEV1)
The forced expiratory volume in 1s measured during pulmonary function tests.
Measured: 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- wang kaifei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, wang kaifei, Chinese PLA General Hospital
- Investigators
- Fei Xie, Dr, Study director, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502405
- Sponsor's protocol ID
- EIT and PFTs
- Status last verified
- Jul 2024
- First submitted
- 9 Jul 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol and research data.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Application of Electrical Impedance Tomography in Bronchial Challenge Testing
- ClinicalTrials.gov ID
- NCT06502405
- Acronym / sponsor ID
- EIT and PFTs
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- wang kaifeiUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 16 Jul 2024 (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.
The purpose of this study was to examine whether electrical impedance tomography (EIT) was capable of identifying the deteriorated lung function on a regional level during bronchial challenge testing and whether EIT may provide additional information during bronchial challenge testing and identify spatial and temporal heterogeneity of regional lung function.
Detailed description
The content of this study includes:
- Can EIT identify the uneven ventilation caused by airway contraction in patients during bronchial provocation tests.
- Can EIT monitor airway contraction in patients before Spirometer examination after inhaling activators.
- Can EIT observe uneven ventilation caused by airway contraction through tidal breathing after the patient inhales activator.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients need to exclude or confirm a suspected diagnosis of asthma through bronchial challenge testing.
Key inclusion criteria (5 listed)
- Patients suspected of asthma who require bronchial challenge testing.
- The Bronchodilator responsiveness testing is negative.
- patients with a pre-bronchodilator FEV1 >60% predicted.
- No contraindications for bronchial provocation test examination.
- Fully understand the purpose and significance of this study, and voluntarily participate in the research.
Key exclusion criteria (4 listed)
- 1. patients with a pre-bronchodilator FEV1≤60% predicted.
- Contraindications for bronchial challenge testing.
- Pregnant or lactating women.
- After pacemaker surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
global inhomogeneity index （GI）
Time frame: 1day
Measured by EIT, used to describe the overall degree of spatial heterogeneity of ventilation.
forced expiratory volume in 1s (FEV1)
Time frame: 1day
The forced expiratory volume in 1s measured during pulmonary function tests.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: Yes. Study Protocol and research data.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
Fei Xie, Dr study director
Chinese PLA General Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by wang kaifei.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lu Cao, Master (13810389517, caolu301@163.om), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
global inhomogeneity index （GI） (time frame: 1day). 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 16 Jul 2024.