Pulmonary Disease, Chronic ObstructiveNCT02929537
China Chronic Obstructive Pulmonary Disease Registration Research
An observational study of Pulmonary Disease, Chronic Obstructive, run by Henan University of Traditional Chinese Medicine.
Trial summary
With the comparative effectiveness research methods and hospital registration study approach, the purpose of this study is to objectively record the methods, efficacy and its influencing factors of COPD commonly used treatment methods/programs (Western medicine, Traditional Chinese Medicine and Integrative Medicine)… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- How many people
- 3,012 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Dec 2019
- How long will I take part?
- 3 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Peoples are diagnosed with Chronic Obstructive Pulmonary Disease (COPD).
Who may be able to join
- A confirmed diagnosis of COPD.
- With the informed consent signed.
Who cannot join
- Pregnant or breast-feeding women.
- Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study .
- Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within the last 5 years.
- Complicated with respiratory disorders other than COPD (e.g., lung fibrosis, pulmonary thromboembolic).
- Complicated with heart failure (NYHA Class III or IV),or myocardial infarction within six months.
- Complicated with serious hepatic and renal diseases (liver cirrhosis, portal hypertension, bleeding of varicose veins, dialysis, or renal transplantation).
About this study
Official title: Transformation and Application of Diagnosis and Treatment Programs for COPD Based on Chronic Obstructive Pulmonary Disease Registration Research in China
With the comparative effectiveness research methods and hospital registration study approach, the purpose of this study is to objectively record the methods, efficacy and its influencing factors of COPD commonly used treatment methods/programs (Western medicine, Traditional Chinese Medicine and Integrative Medicine) in the actual medical environment, analysis of application characteristics for the different programs, and provide the basis for its revision and promotion. It is a first registration study for COPD in China.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is a major disease of harm public health seriously. Although different treatment methods / programs (Western medicine, Traditional Chinese Medicine and Integrative Medicine) exist and are being developed to relieve symptoms and reduce mortality in COPD, most have only been studied in randomized controlled trials (RCT).
Most RCT study patients usually require a single disease, the use of standard treatment and a single intervention to evaluate interventions in an ideal state can achieve maximum effect,that is theoretical effect, it is difficult to provide the evidence of practical clinical efficacy or effectiveness. Secondly, RCT often require strict inclusion and exclusion criteria, resulting in inadequate representation of the study, thus limiting its conclusions spread to overall. There are some challenges for different treatment methods on the actual effect of the patients in the evaluation of conventional medical practice with RCT.
Real World Research based on clinical practice pay close attention highly in response to these problems, and the registry study had been applied widely in clinical practice. With the comparative effectiveness research methods and hospital registration study approach, based on the classes of medications recommended by 2014 GOLD and Chinese Treatment Guidelines for COPD, the purpose of this study is to objectively record the methods, efficacy and its influencing factors of COPD commonly used treatment methods/programs (Western medicine, Traditional Chinese Medicine and Integrative Medicine) in the actual medical environment, analysis of application characteristics for the different programs, and provide the basis for its revision and promotion. This is a first registration study for COPD in China.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Pulmonary Disease, Chronic Obstructive, registration research, Medicine, Chinese Traditional
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Western medicine | Patients in this group only choose conventional medicine treatment based on the classes of medications recommended by 2015 GOLD for COPD. | |
| Traditional Chinese Medicine | Patients in this group only choose conventional medicine treatment based on the Chinese Treatment Guidelines for COPD. | |
| Integrative Medicine | Patients in this group choose western medicine and Traditional Chinese Medicine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of exacerbation
Measured: Change from Baseline in the frequency of exacerbation at the months 3, 6, 9, 12, 15, 18, 21 and 24.
Secondary outcomes (5)
all cause mortality
Measured: through study completion, an average of 1 year
Forced expiratory volume in one second,FEV1
Measured: Change from Baseline in the FEV1 at the months 6, 12, 18 and 24.
Dyspnea
Using modified british medical research council (mMRC) to assess the degree of dyspnea in patients with COPD, and how this changes over time.
Measured: Change from Baseline in the mMRC at the months 3, 6, 9, 12, 15, 18, 21 and 24.
Symptoms
Using the COPD Assessment Test (CAT) as a comprehensive measure of symptoms.
Measured: Change from Baseline in the CAT at the months 6, 12, 18 and 24.
Quality of life
Using the Chinese version of the 36-item Short Form Health Survey (SF-36) to measure quality of life.
Measured: Change from Baseline in the SF-36 at the months 6, 12, 18 and 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2016 (estimated)
- Study startMay 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 3,012 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiansheng Li, doctor, Study chair, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929537
- Sponsor's protocol ID
- COPD registration
- Status last verified
- Feb 2018
- First submitted
- 29 Sep 2015
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transformation and Application of Diagnosis and Treatment Programs for COPD Based on Chronic Obstructive Pulmonary Disease Registration Research in China
- ClinicalTrials.gov ID
- NCT02929537
- Acronym / sponsor ID
- COPD registration
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Pulmonary Disease, Chronic Obstructive, registration research, Medicine, Chinese Traditional
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,012 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 11 Oct 2016 (estimated)
- 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.
With the comparative effectiveness research methods and hospital registration study approach, the purpose of this study is to objectively record the methods, efficacy and its influencing factors of COPD commonly used treatment methods/programs (Western medicine, Traditional Chinese Medicine and Integrative Medicine) in the actual medical environment, analysis of application characteristics for the different programs, and provide the basis for its revision and promotion. It is a first registration study for COPD in China.
Detailed description
Chronic obstructive pulmonary disease (COPD) is a major disease of harm public health seriously. Although different treatment methods / programs (Western medicine, Traditional Chinese Medicine and Integrative Medicine) exist and are being developed to relieve symptoms and reduce mortality in COPD, most have only been studied in randomized controlled trials (RCT).
Most RCT study patients usually require a single disease, the use of standard treatment and a single intervention to evaluate interventions in an ideal state can achieve maximum effect,that is theoretical effect, it is difficult to provide the evidence of practical clinical efficacy or effectiveness. Secondly, RCT often require strict inclusion and exclusion criteria, resulting in inadequate representation of the study, thus limiting its conclusions spread to overall. There are some challenges for different treatment methods on the actual effect of the patients in the evaluation of conventional medical practice with RCT.
Real World Research based on clinical practice pay close attention highly in response to these problems, and the registry study had been applied widely in clinical practice. With the comparative effectiveness research methods and hospital registration study approach, based on the classes of medications recommended by 2014 GOLD and Chinese Treatment Guidelines for COPD, the purpose of this study is to objectively record the methods, efficacy and its influencing factors of COPD commonly used treatment methods/programs (Western medicine, Traditional Chinese Medicine and Integrative Medicine) in the actual medical environment, analysis of application characteristics for the different programs, and provide the basis for its revision and promotion. This is a first registration study for COPD in China.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Western medicine | – | –Patients in this group only choose conventional medicine treatment based on the classes of medications recommended by 2015 GOLD for COPD. |
| Traditional Chinese Medicine | – | –Patients in this group only choose conventional medicine treatment based on the Chinese Treatment Guidelines for COPD. |
| Integrative Medicine | – | –Patients in this group choose western medicine and Traditional Chinese Medicine. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Peoples are diagnosed with Chronic Obstructive Pulmonary Disease (COPD).
Key inclusion criteria (2 listed)
- A confirmed diagnosis of COPD.
- With the informed consent signed.
Key exclusion criteria (6 listed)
- Pregnant or breast-feeding women.
- Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study .
- Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within the last 5 years.
- Complicated with respiratory disorders other than COPD (e.g., lung fibrosis, pulmonary thromboembolic).
- Complicated with heart failure (NYHA Class III or IV),or myocardial infarction within six months.
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
The frequency of exacerbation
Time frame: Change from Baseline in the frequency of exacerbation at the months 3, 6, 9, 12, 15, 18, 21 and 24.
5 secondary outcomes
all cause mortality
Time frame: through study completion, an average of 1 year
Forced expiratory volume in one second,FEV1
Time frame: Change from Baseline in the FEV1 at the months 6, 12, 18 and 24.
Dyspnea
Time frame: Change from Baseline in the mMRC at the months 3, 6, 9, 12, 15, 18, 21 and 24.
Symptoms
Time frame: Change from Baseline in the CAT at the months 6, 12, 18 and 24.
Quality of life
Time frame: Change from Baseline in the SF-36 at the months 6, 12, 18 and 24.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
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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.
Jiansheng Li, doctor study chair
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by Henan University of Traditional Chinese Medicine.
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 2 inclusion and 6 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 6 Feb 2018. 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?
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?
The frequency of exacerbation (time frame: Change from Baseline in the frequency of exacerbation at the months 3, 6, 9, 12, 15, 18, 21 and 24.). 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 6 Feb 2018.