Healthy SubjectsNCT03467880
Multicenter Study of Impulse Oscillometry in Chinese
An observational study of Healthy Subjects and Chronic Obstructive Pulmonary Disease, run by Guangzhou Institute of Respiratory Disease at 2 sites in China.
Trial summary
The purpose of this study is to establish the reference values of impulse oscillometry (IOS) in healthy Chinese, and compare the indices of IOS in patients with lung disease, such as chronic obstructive pulmonary disease (COPD), asthma, interstitial lung disease (ILD), and upper airway Obstruction (UAO). Read more about this study
- Who is it for?
- Ages 4 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Chronic Obstructive Pulmonary Disease, Asthma
- What is being tested?
- Clinical Observation
- How many people
- 4,000 participants
- Where
- 2 sitesChina
- Study dates
- Sep 2016to Dec 2018
- How long will I take part?
- 1 Day
- 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 4 to 95 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Subjects will be recruited from outpatient clinics.
Who may be able to join
- life-long non-smokers
- no symptoms and history of chronic cardiopulmonary diseases (chronic bronchitis, asthma, lung cancer, pulmonary fibrosis, pulmonary tuberculosis, chronic heart diseases, etc.)
- no abnormal findings on physical examination
- written informed consent was obtained
- Diagnosis of chronic obstructive pulmonary disease (COPD), as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines and post-bronchodilator FEV1/FVC (forced vital capacity) < 70%.
- Diagnosis of asthma, as classified by national and international asthma guidelines.
- ILD diagnosis confirmed by lung biopsy, X ray or BALF analysis.
- Diagnosis of UAO.
Who cannot join
- upper or lower respiratory infection within 4 weeks
- long-term exposure to harmful gas or particles
- using β-blocker for treatment
- pregnant women, epileptic
- other diseases or surgeries potentially affecting lung function
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Beijing Hospital
Beijing, 100005
Yimeng Yang, +86 13911738389, d860@sina.com
Tieying Sun
- Not yet recruiting
State Key Laboratory of Respiratory Disease,China Clinical Research Center of Respiratory Disease, Guangzhou Institute of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510120
Jinping Zheng, MD, +86-20-83062729, jpzhenggy@163.com
About this study
The purpose of this study is to establish the reference values of impulse oscillometry (IOS) in healthy Chinese, and compare the indices of IOS in patients with lung disease, such as chronic obstructive pulmonary disease (COPD), asthma, interstitial lung disease (ILD), and upper airway Obstruction (UAO).
- Conditions
- Healthy Subjects, Chronic Obstructive Pulmonary Disease, Asthma, Interstitial Lung Disease, Upper Airway Obstruction
- Being tested
- Clinical Observation
- Keywords
- Impulse Oscillometry, Chinese, Healthy Subjects, Chronic Obstructive Pulmonary Disease, Asthma, Interstitial Lung Disease, Upper Airway Obstruction, Reference Values
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma, Lung Diseases, Interstitial, Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical ObservationOther
No treatment given but observation with IOS
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Healthy subjects. Receives: Other: Clinical Observation | |
| Chronic obstructive pulmonary disease | Patience with chronic obstructive pulmonary disease. Receives: Other: Clinical Observation | |
| Asthma | Patience with asthma. Receives: Other: Clinical Observation | |
| Interstitial lung disease | Patience with interstitial lung disease. Receives: Other: Clinical Observation | |
| Upper airway obstruction | Patience with upper airway obstruction. Receives: Other: Clinical Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway resistance
The indices of Airway resistance include total respiratory impedance (Zrs).
Measured: one minute
Secondary outcomes (1)
forced vital capacity (FVC), forced expiratory volume in one second (FEV1), FEV1/FVC, and maximum midexpiratory flow (MMEF).
The indices of spirometry include forced vital capacity (FVC), forced expiratory volume in one second (FEV1), FEV1/FVC, and maximum midexpiratory flow (MMEF).
Measured: one minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study startSep 2016
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies 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
- Cross-sectional
- Enrolment
- 4,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Hospital, Beijing Children's Hospital, Shanghai Zhongshan Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, West China Hospital, Tongji Hospital, Third Military Medical University, Xiangya Hospital of Central South University, People's Hospital of Anshun City of Guizhou Province, Shanghai Pulmonary Hospital, Shanghai, China, Beijing Chao Yang Hospital
- Responsible party
- Principal investigator, Jinping Zheng, Guangzhou Institute of Respiratory Disease
- Investigators
- Jinping Zheng, MD, Study chair, State Key Laboratory of Respiratory Disease,China Clinical Research Center of Respiratory Disease, Guangzhou Institute of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467880
- Sponsor's protocol ID
- GIRD201536
- Status last verified
- Mar 2018
- First submitted
- 14 Feb 2018
- Last updated
- 16 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liang XL, Gao Y, Guan WJ, Du J, Chen L, Han W, Liu JM, Lu Y, Peng Y, Zhao BR, Wang T, Zheng JP. Reference values of respiratory impedance with impulse oscillometry in healthy Chinese adults. J Thorac Dis. 2021 Jun;13(6):3680-3691. doi: 10.21037/jtd-20-3376.
PubMed 34277060
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study of Impulse Oscillometry in Chinese
- ClinicalTrials.gov ID
- NCT03467880
- Acronym / sponsor ID
- GIRD201536
- Conditions
- Healthy Subjects, Chronic Obstructive Pulmonary Disease, Asthma, Interstitial Lung Disease, Upper Airway Obstruction
- Keywords
- Impulse Oscillometry, Chinese, Healthy Subjects, Chronic Obstructive Pulmonary Disease, Asthma, Interstitial Lung Disease, Upper Airway Obstruction, Reference Values
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Collaborators
- Beijing Hospital, Beijing Children's Hospital, Shanghai Zhongshan Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, West China Hospital, Tongji Hospital, Third Military Medical University, Xiangya Hospital of Central South University, People's Hospital of Anshun City of Guizhou Province, Shanghai Pulmonary Hospital, Shanghai, China, Beijing Chao Yang Hospital
- Study start
- Sep 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 16 Mar 2018 (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 is to establish the reference values of impulse oscillometry (IOS) in healthy Chinese, and compare the indices of IOS in patients with lung disease, such as chronic obstructive pulmonary disease (COPD), asthma, interstitial lung disease (ILD), and upper airway Obstruction (UAO).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | Other: Clinical ObservationHealthy subjects. |
| Chronic obstructive pulmonary disease | – | Other: Clinical ObservationPatience with chronic obstructive pulmonary disease. |
| Asthma | – | Other: Clinical ObservationPatience with asthma. |
| Interstitial lung disease | – | Other: Clinical ObservationPatience with interstitial lung disease. |
| Upper airway obstruction | – | Other: Clinical ObservationPatience with upper airway obstruction. |
Who may qualify
- Ages
- 4 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects will be recruited from outpatient clinics.
Key inclusion criteria (8 listed)
- life-long non-smokers
- no symptoms and history of chronic cardiopulmonary diseases (chronic bronchitis, asthma, lung cancer, pulmonary fibrosis, pulmonary tuberculosis, chronic heart diseases, etc.)
- no abnormal findings on physical examination
- written informed consent was obtained
- Diagnosis of chronic obstructive pulmonary disease (COPD), as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines and post-bronchodilator FEV1/FVC (forced vital capacity) < 70%.
Key exclusion criteria (5 listed)
- upper or lower respiratory infection within 4 weeks
- long-term exposure to harmful gas or particles
- using β-blocker for treatment
- pregnant women, epileptic
- other diseases or surgeries potentially affecting lung function
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 |
|---|---|---|
| Clinical ObservationNo treatment given but observation with IOS | Other | Asthma, Chronic obstructive pulmonary disease, Healthy subjects, Interstitial lung disease, Upper airway obstruction |
Primary outcome
Airway resistance
Time frame: one minute
The indices of Airway resistance include total respiratory impedance (Zrs).
1 secondary outcome
forced vital capacity (FVC), forced expiratory volume in one second (FEV1), FEV1/FVC, and maximum midexpiratory flow (MMEF).
Time frame: one minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2018.
- Derived from this study: PubMed 34277060Liang XL, Gao Y, Guan WJ, Du J, Chen L, Han W, Liu JM, Lu Y, Peng Y, Zhao BR, Wang T, Zheng JP. Reference values of respiratory impedance with impulse oscillometry in healthy Chinese adults. J Thorac Dis. 2021 Jun;13(6):3680-3691. doi: 10.21037/jtd-20-3376.
Related trials for Healthy Subjects
Not yet recruitingPhase 1
A Study of Phenytoin Mucoadhesive Film for Oral Ulcers in Healthy Volunteers
Oral Ulcer, Oral Mucositis
Not yet recruiting
SUVY VerSus SAccharose (SUVISA)
Healthy Volunteers, Erythritol
Not yet recruitingObservational study
Microneurographic Assessment of Peripheral Nerves in Healthy Volunteers and Individuals With Sensory Dysfunction Caused by Inherited Mutations in the PIEZO2 Gene
PIEZO2-Deficiency Syndrome
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
RecruitingPhase 1
First-in-Human Evaluation of [11C]JMJ-129-d2 for PDE4D Imaging in Healthy Volunteers
Healthy
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.
Jinping Zheng, MD study chair
State Key Laboratory of Respiratory Disease,China Clinical Research Center of Respiratory Disease, Guangzhou Institute of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Subjects and Chronic Obstructive Pulmonary Disease, run by Guangzhou Institute of Respiratory Disease at 2 sites in China.
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 8 inclusion and 5 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 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinping Zheng, MD (+86-20-83062729, jpzhenggy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Airway resistance (time frame: one minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03467880, which also lists 1 linked publication.
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 Mar 2018.