Pulmonary Disease, Chronic ObstructiveNCT03007914
Effect of Traditional Chinese Medicine on Outcomes in COPD Patients
An observational study of Pulmonary Disease, Chronic Obstructive, run by Henan University of Traditional Chinese Medicine.
Trial summary
The aim of this study is to compare the effectiveness of the treatments in two cohort for COPD patients: one, traditional Chinese medicine (TCM) cohort, which have been evaluated and have certain effect; the other, conventional medicine treatments cohort, based on 2015 Global Initiative for Chronic Obstructive Lung… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- How many people
- 2,540 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to May 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients
Who may be able to join
- A confirmed diagnosis of COPD.
- Medically stable.
- Age between 40 and 80 years.
- Syndrome differentiation belongs to syndrome of deficiency of deficiency of lung qi, deficiency of pulmonic-splenic qi, syndrome of insufficiency of qi of the lung and kidney, syndrome of insufficiency of qi and yin of the lung and kidney.
- With the informed consent signed.
- Capable of complying with the dosing regimen and visit schedules.
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.
- Current respiratory disorders other than COPD (e.g., bronchiectasis, bronchial asthma, tuberculosis, lung fibrosis, pulmonary thromboembolic, diffuse panbronchiolitis).
- Complicated with heart failure (NYHA Class III or IV),or myocardial infarction within six months ,or unstable hemodynamics.
- Complicated with serious hepatic and renal diseases (liver cirrhosis, portal hypertension, bleeding of varicose veins, dialysis, or renal transplantation).
- Complicated with congenital or acquired immune deficiency.
- Participating in other trials or allergic to the used medicine.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multi-center, Prospective, Cohort Study to Evaluate the Effectiveness of Traditional Chinese Medicine on COPD Patients
The aim of this study is to compare the effectiveness of the treatments in two cohort for COPD patients: one, traditional Chinese medicine (TCM) cohort, which have been evaluated and have certain effect; the other, conventional medicine treatments cohort, based on 2015 Global Initiative for Chronic Obstructive Lung Disease (GOLD).
Read the detailed description
COPD, with high prevalence, morbidity, mortality and economic burdens, affects millions worldwide. Although many therapies exist and are being developed to relieve symptoms and reduce mortality in COPD, most have only been studied in placebo-controlled efficacy studies in highly selected populations. There are few clinical trials to compare therapeutic alternatives in real world. Furthermore, some randomized controlled trials on comprehensive TCM interventions, especially based on the TCM patterns, have been the certain evidence for showing definite effect for COPD patients. In addition, studies in real world populations of COPD that received different therapies that do have efficacy evidence was found wide variations in care delivery. In short, there is a need for cohort study in COPD.
This is a multi-center, prospective, cohort study to evaluate the effectiveness of TCM on COPD patients. The cohort study will enroll approximately 2540 patients that in two cohort, one, TCM cohort, which have been evaluated and have certain effect; the other, conventional medicine treatments cohort, based on 2015 Global Initiative for Chronic Obstructive Lung Disease (GOLD).Subjects in two cohort will be followed-up 2 years.The primary outcome measure is the frequency of exacerbations. The secondary efficacy measures include mortality rate and all-cause mortality, FEV1, dyspnea (MMRC), exercise capacity( 6MWD), quality of life ( CAT, SF-36 and COPD-PRO), and effectiveness satisfaction with treatment(ESQ-COPD).
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Pulmonary Disease, Chronic Obstructive, Medicine, Chinese Traditional, Humans, Treatment Outcome
- 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 |
|---|---|---|
| TCM cohort | Patients continue to receive the routine TCM treatments recommended by 2011 Chinese treatment guidelines of TCM for COPD. | |
| Conventional medicine cohort | Patients continue to receive the conventional medicine recommended by 2014 GOLD and Chinese treatment guidelines for COPD. |
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 of the follow up phase.
Secondary outcomes (8)
All cause mortality
Measured: The all-cause mortality in 2 years of the follow up phase.
Forced expiratory volume in one second
FEV1 is the amount of air that can be exhaled in one second.
Measured: Change from Baseline in the one second (FEV1) at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.
Dyspnea
Using Modified Medical Research Council (MMRC) scale to assess a patient's level of dyspnea. The MMRC scale is a simple grading system that scored from 0 (less severe) to 4 (severe).
Measured: Change from Baseline in MMRC at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.
Minutes Walking Distance Test (6MWD)
Measured: Change from Baseline in the 6MWD at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.
COPD Assessment Test (CAT)
Using the CAT to evaluate the impact of COPD on a person's life over time.
Measured: Change from Baseline in the CAT at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.
Effectiveness satisfaction with treatment
Using the effectiveness satisfaction questionnaire of chronic obstructive pulmonary disease (ESQ-COPD) to evaluate COPD patients' satisfaction with their treatment over time.
Measured: Change from Baseline in the ESQ-COPD at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.
Short Form 36-Item Health Survey (SF-36)
Using the SF-36 to evaluate the impact of COPD on a person's life over time.
Measured: Change from Baseline in the SF-36 at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.
Patient reported outcome for COPD (COPD-PRO)
Using the COPD-PRO to evaluate the impact of COPD on a person's life over time.
Measured: Change from Baseline in the COPD-PRO at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,540 participants (estimated)
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
- NCT03007914
- Sponsor's protocol ID
- TCM for COPD Cohort
- Status last verified
- Dec 2016
- First submitted
- 26 Dec 2016
- Last updated
- 2 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Prospective, Cohort Study to Evaluate the Effectiveness of Traditional Chinese Medicine on COPD Patients
- ClinicalTrials.gov ID
- NCT03007914
- Acronym / sponsor ID
- TCM for COPD Cohort
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Pulmonary Disease, Chronic Obstructive, Medicine, Chinese Traditional, Humans, Treatment Outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,540 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 2 Jan 2017 (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.
The aim of this study is to compare the effectiveness of the treatments in two cohort for COPD patients: one, traditional Chinese medicine (TCM) cohort, which have been evaluated and have certain effect; the other, conventional medicine treatments cohort, based on 2015 Global Initiative for Chronic Obstructive Lung Disease (GOLD).
Detailed description
COPD, with high prevalence, morbidity, mortality and economic burdens, affects millions worldwide. Although many therapies exist and are being developed to relieve symptoms and reduce mortality in COPD, most have only been studied in placebo-controlled efficacy studies in highly selected populations. There are few clinical trials to compare therapeutic alternatives in real world. Furthermore, some randomized controlled trials on comprehensive TCM interventions, especially based on the TCM patterns, have been the certain evidence for showing definite effect for COPD patients. In addition, studies in real world populations of COPD that received different therapies that do have efficacy evidence was found wide variations in care delivery. In short, there is a need for cohort study in COPD.
This is a multi-center, prospective, cohort study to evaluate the effectiveness of TCM on COPD patients. The cohort study will enroll approximately 2540 patients that in two cohort, one, TCM cohort, which have been evaluated and have certain effect; the other, conventional medicine treatments cohort, based on 2015 Global Initiative for Chronic Obstructive Lung Disease (GOLD).Subjects in two cohort will be followed-up 2 years.The primary outcome measure is the frequency of exacerbations. The secondary efficacy measures include mortality rate and all-cause mortality, FEV1, dyspnea (MMRC), exercise capacity( 6MWD), quality of life ( CAT, SF-36 and COPD-PRO), and effectiveness satisfaction with treatment(ESQ-COPD).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCM cohort | – | –Patients continue to receive the routine TCM treatments recommended by 2011 Chinese treatment guidelines of TCM for COPD. |
| Conventional medicine cohort | – | –Patients continue to receive the conventional medicine recommended by 2014 GOLD and Chinese treatment guidelines for COPD. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients
Key inclusion criteria (6 listed)
- A confirmed diagnosis of COPD.
- Medically stable.
- Age between 40 and 80 years.
- Syndrome differentiation belongs to syndrome of deficiency of deficiency of lung qi, deficiency of pulmonic-splenic qi, syndrome of insufficiency of qi of the lung and kidney, syndrome of insufficiency of qi and yin of the lung and kidney.
- With the informed consent signed.
Key exclusion criteria (8 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.
- Current respiratory disorders other than COPD (e.g., bronchiectasis, bronchial asthma, tuberculosis, lung fibrosis, pulmonary thromboembolic, diffuse panbronchiolitis).
- Complicated with heart failure (NYHA Class III or IV),or myocardial infarction within six months ,or unstable hemodynamics.
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 of the follow up phase.
8 secondary outcomes
All cause mortality
Time frame: The all-cause mortality in 2 years of the follow up phase.
Forced expiratory volume in one second
Time frame: Change from Baseline in the one second (FEV1) at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.
Dyspnea
Time frame: Change from Baseline in MMRC at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.
Minutes Walking Distance Test (6MWD)
Time frame: Change from Baseline in the 6MWD at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.
COPD Assessment Test (CAT)
Time frame: Change from Baseline in the CAT at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.
Effectiveness satisfaction with treatment
Time frame: Change from Baseline in the ESQ-COPD at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.
Short Form 36-Item Health Survey (SF-36)
Time frame: Change from Baseline in the SF-36 at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.
Patient reported outcome for COPD (COPD-PRO)
Time frame: Change from Baseline in the COPD-PRO at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2017.
- 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.
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 6 inclusion and 8 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 2 Jan 2017. 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 Yang Xie, Doctor (+86 371 66248624, xieyanghn@163.com), or a site near the patient. 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 of the follow up phase.). 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 2 Jan 2017.