Pulmonary Disease, Chronic ObstructivePhase 3NCT01482000
Does Pulmonary Daoyin of China Give Additional Benefit Over Usual Therapy in Management of Stable Chronic Obstructive Pulmonary Disease?
A Phase 3 study testing Pulmonary daoyin therapy of China in people with Pulmonary Disease, Chronic Obstructive, run by Henan University of Traditional Chinese Medicine.
Trial summary
The purpose of this study is to compare the exercise capacity and pulmonary function test parameters of Chronic Obstructive Pulmonary Disease (COPD) patients who underwent usual care with and without pulmonary daoyin therapy of China in community. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Pulmonary daoyin therapy of China
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 464 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Dec 2013
- Phase
- Phase 3
- 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
Who may be able to join
- A confirmed diagnosis of moderate to very severe COPD.
- Age between 40 and 80 years.
- Without participation in other interventional trials in the previous one month.
- With the informed consent signed.
Who cannot join
- Patients with poor mobility that can not do the exercise, i.e. wheelchair bound.
- Pregnant or breast-feeding women.
- Resting pulmonary artery pressure > 45mmHg.
- Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
- Patients with severe comorbidities, including acute myocardial infarction and unstable angina pectoris.
- Patients with post exercise syncope and osteoarthrosis that affect movement.
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- Complicated with severe heart failure (class II to IV NYHA heart function).
- Complicated with bronchial asthma, bronchiectasis or active tuberculosis;
- Complicated with obliterative bronchiolitis or diffuse pantothenic bronchiolitis，
- Complicated with pneumothorax, pleural effusion or pulmonary embolism.
- Complicated with neuromuscular disorder which affects the respiration.
- Complicated with tumors .
- Complicated with serious hepatic and renal diseases.
- Long periods of bed rest .
- Participating in other trials or allergic to the used medicine.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Detection and Intervention on Mild/Moderate Chronic Obstructive Pulmonary Disease by Traditional Chinese Medicine Treatment and Application
The purpose of this study is to compare the exercise capacity and pulmonary function test parameters of Chronic Obstructive Pulmonary Disease (COPD) patients who underwent usual care with and without pulmonary daoyin therapy of China in community.
Read the detailed description
This is a multicenter, randomized, none-blind, controlled study to evaluate the effect of pulmonary daoyin therapy in moderate to very severe COPD subjects. Following a 14 day run-in period, approximately 464 subjects will be randomly assigned to none-blind treatment for 3 months. The primary measure of efficacy is the Exercise Capacity (6MWD) and spirometric values (e.g. FEV1). Secondary efficacy measures include Dyspnea (MMRC), Quality of life (CAT,SF-36), frequency of exacerbations. Safety will be assessed through the collection of adverse events. There will be a total of 4 study visits (randomization, and after 1,2,3 months of treatment).
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Pulmonary daoyin therapy of China, usual care
- Keywords
- Pulmonary Disease, Chronic Obstructive, Adult, therapeutic use, Humans, Treatment Outcome, daoyin therapy
- 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.
Pulmonary daoyin therapy of ChinaOther
The intervention group will perform a 3 months pulmonary daoyin of China therapy program which consists of training and patient education. They will be evaluated with some tests for the study.
usual careOther
The control group will get the usual care with some additional tests for the study.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary daoyin therapy of China | Experimental | The intervention group will perform a 3 months pulmonary daoyin of China therapy program which consists of training and patient education. They will be evaluated with some tests for the study. Receives: Other: Pulmonary daoyin therapy of China |
| Control | Active comparator | The control group will get the usual care with some additional tests for the study. Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minutes Walking Distance Test ( 6MWD)
Measured: Change from Baseline in 6MWD at month 3 of the treatment phase
Forced expiratory volume in one second, FEV1
Measured: Change from Baseline in FEV1 at month 3 of the treatment phase
Secondary outcomes (2)
Modified Medical Research Council (MMRC) scale
Measured: Change from Baseline in MMRC at month 1, 2 and 3 months of the treatment phase
Quality of life
using COPD Assessment Test (CAT) and short-form 36-item questionnaire (SF-36).
Measured: Change from Baseline in CAT and SF-36 at month 3 of the treatment phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (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 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 464 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li jiansheng, doctor, Study chair, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482000
- Sponsor's protocol ID
- Daoyin therapy for COPD
- Status last verified
- Oct 2011
- First submitted
- 18 Nov 2011
- Last updated
- 30 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yu XQ, Li JS, Li SY, Xie Y, Wang MH, Zhang HL, Wang HF, Wang ZW. Functional and psychosocial effects of pulmonary Daoyin on patients with COPD in China: study protocol of a multicenter randomized controlled trial. J Integr Med. 2013 Mar;11(2):140-6. doi: 10.3736/jintegrmed2013015.
PubMed 23506695
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection and Intervention on Mild/Moderate Chronic Obstructive Pulmonary Disease by Traditional Chinese Medicine Treatment and Application
- ClinicalTrials.gov ID
- NCT01482000
- Acronym / sponsor ID
- Daoyin therapy for COPD
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Pulmonary Disease, Chronic Obstructive, Adult, therapeutic use, Humans, Treatment Outcome, daoyin therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 464 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 30 Nov 2011 (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 purpose of this study is to compare the exercise capacity and pulmonary function test parameters of Chronic Obstructive Pulmonary Disease (COPD) patients who underwent usual care with and without pulmonary daoyin therapy of China in community.
Detailed description
This is a multicenter, randomized, none-blind, controlled study to evaluate the effect of pulmonary daoyin therapy in moderate to very severe COPD subjects. Following a 14 day run-in period, approximately 464 subjects will be randomly assigned to none-blind treatment for 3 months. The primary measure of efficacy is the Exercise Capacity (6MWD) and spirometric values (e.g. FEV1). Secondary efficacy measures include Dyspnea (MMRC), Quality of life (CAT,SF-36), frequency of exacerbations. Safety will be assessed through the collection of adverse events. There will be a total of 4 study visits (randomization, and after 1,2,3 months of treatment).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary daoyin therapy of China | Experimental | Other: Pulmonary daoyin therapy of ChinaThe intervention group will perform a 3 months pulmonary daoyin of China therapy program which consists of training and patient education. They will be evaluated with some tests for the study. |
| Control | Active comparator | Other: usual careThe control group will get the usual care with some additional tests for the study. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A confirmed diagnosis of moderate to very severe COPD.
- Age between 40 and 80 years.
- Without participation in other interventional trials in the previous one month.
- With the informed consent signed.
Key exclusion criteria (15 listed)
- Patients with poor mobility that can not do the exercise, i.e. wheelchair bound.
- Pregnant or breast-feeding women.
- Resting pulmonary artery pressure > 45mmHg.
- Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
- Patients with severe comorbidities, including acute myocardial infarction and unstable angina pectoris.
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 |
|---|---|---|
| Pulmonary daoyin therapy of ChinaThe intervention group will perform a 3 months pulmonary daoyin of China therapy program which consists of training and patient education. They will be evaluated with some tests for the study. | Other | Pulmonary daoyin therapy of China |
| usual careThe control group will get the usual care with some additional tests for the study. | Other | Control |
Primary outcome
6 Minutes Walking Distance Test ( 6MWD)
Time frame: Change from Baseline in 6MWD at month 3 of the treatment phase
Forced expiratory volume in one second, FEV1
Time frame: Change from Baseline in FEV1 at month 3 of the treatment phase
2 secondary outcomes
Modified Medical Research Council (MMRC) scale
Time frame: Change from Baseline in MMRC at month 1, 2 and 3 months of the treatment phase
Quality of life
Time frame: Change from Baseline in CAT and SF-36 at month 3 of the treatment phase
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2011.
- Derived from this study: PubMed 23506695Yu XQ, Li JS, Li SY, Xie Y, Wang MH, Zhang HL, Wang HF, Wang ZW. Functional and psychosocial effects of pulmonary Daoyin on patients with COPD in China: study protocol of a multicenter randomized controlled trial. J Integr Med. 2013 Mar;11(2):140-6. doi: 10.3736/jintegrmed2013015.
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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.
Li jiansheng, doctor study chair
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pulmonary daoyin therapy of China in people with 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 4 inclusion and 15 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 30 Nov 2011. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yu xueqing, doctor (+86 371 66248624, yxqshi@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Minutes Walking Distance Test ( 6MWD) (time frame: Change from Baseline in 6MWD at month 3 of the treatment phase). 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?
On the ClinicalTrials.gov record for NCT01482000, 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 30 Nov 2011.