COPDNCT04960410
Real Time Early Warning Model and Mobile Medical Assistant System for the Impact of Air Pollution on AECOPD Disease
An observational study of COPD, run by Peking University Third Hospital.
Trial summary
Objective to establish a real-time early warning model of acute exacerbation of chronic obstructive pulmonary disease (COPD) caused by air pollution, and develop the corresponding mobile medical assistant system. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- Types and exposure of different air pollutants
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 30 Dec 2018
- 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 40 to 80 years
- All sexes
- Adult, Older adult
Study population: Stable chronic obstructive pulmonary disease (COPD) patients
Who may be able to join
- Patients aged > 40 and < 80 years with post-bronchodilator FEV1/ forced vital capacity (FVC) < 0.7 and percentage predicted of FEV1>30%, who were no exacerbation of symptoms in the 6 weeks preceding the study, were included in the study.
Who cannot join
- Patients who were diagnosed with other chronic respiratory diseases, including bronchial asthma, bronchiectasis and lung abscess.
- Patients with near-terminal illness, congestive heart failure (NYHA III-IV), or cannot record CAT score timely were excluded.
About this study
Official title: Real Time Early Warning Model and Mobile Medical Assistant System for the Impact of Air Pollution on Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Objective to establish a real-time early warning model of acute exacerbation of chronic obstructive pulmonary disease (COPD) caused by air pollution, and develop the corresponding mobile medical assistant system. Through the cross fusion of existing information technology and medical research results, an auxiliary medical system is formed for information recording, tracking tools, early warning model and clinical diagnosis of patients with COPD.
Read the detailed description
Objective to establish a real-time early warning model of acute exacerbation of chronic obstructive pulmonary disease (COPD) caused by air pollution, and develop the corresponding mobile medical assistant system. Through the cross fusion of existing information technology and medical research results, an auxiliary medical system is formed for information recording, tracking tools, early warning model and clinical diagnosis of patients with COPD.
- Conditions
- COPD
- Being tested
- Types and exposure of different air pollutants
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Types and exposure of different air pollutantsCombination product
Types and exposure of different air pollutants in COPD patients' living and working environment
| Study group | Role | What they receive |
|---|---|---|
| Low air pollution | Not described Receives: Combination Product: Types and exposure of different air pollutants | |
| High air pollution | Not described Receives: Combination Product: Types and exposure of different air pollutants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of acute exacerbations
Frequency of acute exacerbations
Measured: 1 year incidence rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start1 Jan 2017
- Primary completion23 Apr 2017
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beihang University
- Responsible party
- Sponsor
- Investigators
- Yahong Chen, Dr., Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960410
- Sponsor's protocol ID
- LM2018072
- Status last verified
- Jul 2021
- First submitted
- 4 Jul 2021
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real Time Early Warning Model and Mobile Medical Assistant System for the Impact of Air Pollution on Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04960410
- Acronym / sponsor ID
- LM2018072
- Conditions
- COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Beihang University
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 23 Apr 2017 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 13 Jul 2021 (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.
Objective to establish a real-time early warning model of acute exacerbation of chronic obstructive pulmonary disease (COPD) caused by air pollution, and develop the corresponding mobile medical assistant system. Through the cross fusion of existing information technology and medical research results, an auxiliary medical system is formed for information recording, tracking tools, early warning model and clinical diagnosis of patients with COPD.
Detailed description
Objective to establish a real-time early warning model of acute exacerbation of chronic obstructive pulmonary disease (COPD) caused by air pollution, and develop the corresponding mobile medical assistant system. Through the cross fusion of existing information technology and medical research results, an auxiliary medical system is formed for information recording, tracking tools, early warning model and clinical diagnosis of patients with COPD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low air pollution | – | Combination Product: Types and exposure of different air pollutants |
| High air pollution | – | Combination Product: Types and exposure of different air pollutants |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Stable chronic obstructive pulmonary disease (COPD) patients
Key inclusion criteria (1 listed)
- Patients aged > 40 and < 80 years with post-bronchodilator FEV1/ forced vital capacity (FVC) < 0.7 and percentage predicted of FEV1>30%, who were no exacerbation of symptoms in the 6 weeks preceding the study, were included in the study.
Key exclusion criteria (2 listed)
- Patients who were diagnosed with other chronic respiratory diseases, including bronchial asthma, bronchiectasis and lung abscess.
- Patients with near-terminal illness, congestive heart failure (NYHA III-IV), or cannot record CAT score timely were excluded.
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 |
|---|---|---|
| Types and exposure of different air pollutantsTypes and exposure of different air pollutants in COPD patients' living and working environment | Combination product | High air pollution, Low air pollution |
Primary outcome
Frequency of acute exacerbations
Time frame: 1 year incidence rate
Frequency of acute exacerbations
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 13 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Yahong Chen, Dr. study director
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by Peking University Third Hospital.
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 1 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 13 Jul 2021. 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?
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?
Frequency of acute exacerbations (time frame: 1 year incidence rate). 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 13 Jul 2021.