Pulmonary Disease, Chronic ObstructivePhase 2NCT01486186
Effect of Traditional Chinese Medicine on Outcomes in Patients With Mild/Moderate Chronic Obstructive Pulmonary Disease
A Phase 2 study testing Traditional Chinese Medicine in people with Pulmonary Disease, Chronic Obstructive, run by Henan University of Traditional Chinese Medicine.
Trial summary
The purpose of this study is evaluate the effects and safety of Traditional Chinese medicine for prevention and management of mild/moderate chronic obstructive pulmonary disease (COPD). 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?
- Traditional Chinese Medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 504 participants
- Where
- No sites listed yet
- Study dates
- Dec 2011to Dec 2014
- Phase
- Phase 2
- 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 mild/moderate COPD.
- Age between 40 and 80 years.
- Syndrome differentiation belongs to Syndrome of lung-qi deficiency, Syndrome of deficiency of pulmonosplenic qi, Syndrome of insufficiency of QI of the lung and kidney.
- Without participation in other interventional trials in the previous one month.
- 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 .
- Complicated with severe heart failure (class Ⅳ NYHA heart function) or unstable hemodynamics.
- Complicated with bronchial asthma, bronchiectasis or active tuberculosis；
- Complicated with obliterative bronchiolitis or diffuse pantothenic bronchiolitis，
- Complicated with pneumothorax, pleural effusion or pulmonary embolism.
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- Complicated with neuromuscular disorder which affects the respiration.
- Complicated with tumors.
- Complicated with serious hepatic and renal diseases.
- Long periods of bed rest.
- Use of oral or parenteral corticosteroids before 1 months of Visit 1 .
- With immunodeficiency.
- 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 evaluate the effects and safety of Traditional Chinese medicine for prevention and management of mild/moderate chronic obstructive pulmonary disease (COPD).
Read the detailed description
This is a multicenter, randomized, double-blind, placebo controlled study to evaluate the effect of Traditional Chinese medicine (TCM) in COPD subjects. Following a 14 day run-in period, approximately 504 subjects will be randomly assigned to double-blind treatment for 52 weeks. After the 52 weeks treatment period, subjects in both treatment arms will follow-up 52 weeks. The primary measure of efficacy is the frequency of exacerbations and spirometric values (e.g. FEV1). Secondary efficacy measures include Dyspnea (MMRC), Quality of life ( CAT,SF-36), Exercise Capacity( 6MWD). Safety will be assessed through the collection of adverse events. There will be a total of 5 study visits ( randomization, and after 13, 26, 39 and 52 weeks of treatment). A follow-up contact for collection of effect and adverse event will be conducted approximately 52 weeks following the last study visit.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Traditional Chinese Medicine, placebo chinese medicine
- Keywords
- Pulmonary Disease, Chronic Obstructive, Double-Blind Method, 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.
Traditional Chinese MedicineDrug
Also called Baofei granule, Bufeijianpi granule, Bufeiyishen granule
A herbal extract twice daily for 52 weeks for lower dosage, There are 3 Recipe for the 3 traditional Chinese syndrome, they are syndrome of lung-qi deficiency, syndrome of deficiency of pulmonosplenic qi, syndrome of insufficiency of QI of the lung and kidney.
placebo chinese medicineDrug
Also called placebo Baofei granule, placebo Bufeijianpi granule, placebo Bufeiyishen granule
There are 3 placebo Recipe for the 3 traditional Chinese syndrome.
| Study group | Role | What they receive |
|---|---|---|
| traditional chinese medicine | Experimental | The experimental group will receive three type of TCM, they are Baofei granule, Bufeijianpi granule and Bufeiyishen granule. Receives: Drug: Traditional Chinese Medicine |
| placebo | Placebo comparator | placebo chinese medicine in addition to best care according to clinical guidelines for COPD patients Receives: Drug: placebo chinese medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulmonary function（FEV1）
Measured: Change from Baseline in FEV1 at Week 26 and 52 of the treatment phase, Week 26 and 52 of the followup phase
the frequency of exacerbation
Measured: Change from Baseline in the frequency of exacerbation at Week 26 and 52 of the treatment phase, Week 26 and 52 of the followup phase
Secondary outcomes (3)
Dyspnea
Measured: Change from Baseline in MMRC at Week 13, 26, 39 and 52 of the treatment phase, Week 26 and 52 of the followup 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 Week 13, 26, 39 and 52 of the treatment phase, Week 26 and 52 of the followup phase
6 Minutes Walking Distance Test ( 6MWD)
Measured: Change from Baseline in 6MWD at Week 13, 26, 39 and 52 of the treatment phase, Week 26 and 52 of the followup phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 504 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
- NCT01486186
- Sponsor's protocol ID
- TCM for COPD
- Status last verified
- Dec 2011
- First submitted
- 15 Nov 2011
- Last updated
- 6 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang M, Li J, Li S, Wang H, Yu X, Zhang H. Effect of traditional Chinese medicine on outcomes in patients with mild/moderate chronic obstructive pulmonary disease: study protocol for a randomized placebo-controlled trial. Trials. 2012 Jul 16;13:109. doi: 10.1186/1745-6215-13-109.
PubMed 22799753
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 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
- NCT01486186
- Acronym / sponsor ID
- TCM for COPD
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Pulmonary Disease, Chronic Obstructive, Double-Blind Method, Medicine, Chinese Traditional, Humans, Treatment Outcome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 504 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 6 Dec 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 evaluate the effects and safety of Traditional Chinese medicine for prevention and management of mild/moderate chronic obstructive pulmonary disease (COPD).
Detailed description
This is a multicenter, randomized, double-blind, placebo controlled study to evaluate the effect of Traditional Chinese medicine (TCM) in COPD subjects. Following a 14 day run-in period, approximately 504 subjects will be randomly assigned to double-blind treatment for 52 weeks. After the 52 weeks treatment period, subjects in both treatment arms will follow-up 52 weeks. The primary measure of efficacy is the frequency of exacerbations and spirometric values (e.g. FEV1). Secondary efficacy measures include Dyspnea (MMRC), Quality of life ( CAT,SF-36), Exercise Capacity( 6MWD). Safety will be assessed through the collection of adverse events. There will be a total of 5 study visits ( randomization, and after 13, 26, 39 and 52 weeks of treatment). A follow-up contact for collection of effect and adverse event will be conducted approximately 52 weeks following the last study visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| traditional chinese medicine | Experimental | Drug: Traditional Chinese MedicineThe experimental group will receive three type of TCM, they are Baofei granule, Bufeijianpi granule and Bufeiyishen granule. |
| placebo | Placebo comparator | Drug: placebo chinese medicineplacebo chinese medicine in addition to best care according to clinical guidelines for COPD patients |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A confirmed diagnosis of mild/moderate COPD.
- Age between 40 and 80 years.
- Syndrome differentiation belongs to Syndrome of lung-qi deficiency, Syndrome of deficiency of pulmonosplenic qi, Syndrome of insufficiency of QI of the lung and kidney.
- Without participation in other interventional trials in the previous one month.
- With the informed consent signed.
Key exclusion criteria (13 listed)
- Pregnant or breast-feeding women.
- Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study .
- Complicated with severe heart failure (class Ⅳ NYHA heart function) or unstable hemodynamics.
- Complicated with bronchial asthma, bronchiectasis or active tuberculosis；
- Complicated with obliterative bronchiolitis or diffuse pantothenic bronchiolitis，
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 |
|---|---|---|
| Traditional Chinese MedicineAlso: Baofei granule, Bufeijianpi granule, Bufeiyishen granuleA herbal extract twice daily for 52 weeks for lower dosage, There are 3 Recipe for the 3 traditional Chinese syndrome, they are syndrome of lung-qi deficiency, syndrome of deficiency of pulmonosplenic qi, syndrome of insufficiency of QI of the lung and kidney. | Drug | traditional chinese medicine |
| placebo chinese medicineAlso: placebo Baofei granule, placebo Bufeijianpi granule, placebo Bufeiyishen granuleThere are 3 placebo Recipe for the 3 traditional Chinese syndrome. | Drug | placebo |
Primary outcome
pulmonary function（FEV1）
Time frame: Change from Baseline in FEV1 at Week 26 and 52 of the treatment phase, Week 26 and 52 of the followup phase
the frequency of exacerbation
Time frame: Change from Baseline in the frequency of exacerbation at Week 26 and 52 of the treatment phase, Week 26 and 52 of the followup phase
3 secondary outcomes
Dyspnea
Time frame: Change from Baseline in MMRC at Week 13, 26, 39 and 52 of the treatment phase, Week 26 and 52 of the followup phase
Quality of life
Time frame: Change from Baseline in CAT and SF-36 at Week 13, 26, 39 and 52 of the treatment phase, Week 26 and 52 of the followup phase
6 Minutes Walking Distance Test ( 6MWD)
Time frame: Change from Baseline in 6MWD at Week 13, 26, 39 and 52 of the treatment phase, Week 26 and 52 of the followup phase
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2011.
- Derived from this study: PubMed 22799753Wang M, Li J, Li S, Wang H, Yu X, Zhang H. Effect of traditional Chinese medicine on outcomes in patients with mild/moderate chronic obstructive pulmonary disease: study protocol for a randomized placebo-controlled trial. Trials. 2012 Jul 16;13:109. doi: 10.1186/1745-6215-13-109.
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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 2 study testing Traditional Chinese Medicine 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 5 inclusion and 13 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 Dec 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 wang minghang, doctor (+86 371 66248624, wmh107hn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pulmonary function（FEV1） (time frame: Change from Baseline in FEV1 at Week 26 and 52 of the treatment phase, Week 26 and 52 of the followup 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 NCT01486186, 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 6 Dec 2011.