Pulmonary Disease, Chronic ObstructivePhase 3NCT03169504
Effect of Acupuncture on Patients With Chronic Obstructive Pulmonary Disease
A Phase 3 study testing Acupuncture, Conventional drug and Acupuncture plus conventional drug in people with Pulmonary Disease, Chronic Obstructive, run by Henan University of Traditional Chinese Medicine at 1 site in China.
Trial summary
This study aims to compare the efficacy of three therapies for chronic obstructive pulmonary disease (COPD) patients: one, conventional drug based on Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017 and Chinese Medical Association Guidelines; another, acupuncture, an important part of traditional… 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?
- Acupuncture, Conventional drug and Acupuncture plus conventional drug
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- May 2017to Dec 2018
- 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 diagnosis of COPD with classification of airflow limitation severity from GOLD 1 to GLOD 3 according to GOLD 2017.
- Syndrome differentiation meets criteria of Qi deficiency of the lung ZHEGN, Qi deficiency of the lung and spleen ZHEGN, Qi deficiency of the lung and kidney ZHEGN, or Qi and Yin deficiency of the lung and kidney ZHEGN.
- Age ranges from 40 years to 80 years.
Who cannot join
- Pregnant and lactating women.
- Patients with severe cardiovascular and cerebrovascular diseases.
- Patients with severe liver and kidney disease.
- Patients with bronchiectasis, active pulmonary tuberculosis, pulmonary embolism or other severe respiratory diseases.
- Patients with tumor after resection, radiotherapy or chemotherapy in the past 5 years.
- Patients with severe neuromuscular disorders.
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- Patients with severe arthritis.
- Patients with severe peripheral vascular diseases.
- Patients with severe cognitive and psychiatric disorders.
- Patients who have participated in other clinical studies in the past 4 weeks.
- Patients who have experienced one or more acute exacerbation in the past 4 weeks.
- Patients unwilling to sign informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, 450000
Yang Xie, Doctor, 86-371-66248624, xieyanghn@163.com
About this study
Official title: Effect of Acupuncture on Patients With Chronic Obstructive Pulmonary Disease: a Multi-center, Randomized, Controlled Trial
This study aims to compare the efficacy of three therapies for chronic obstructive pulmonary disease (COPD) patients: one, conventional drug based on Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017 and Chinese Medical Association Guidelines; another, acupuncture, an important part of traditional Chinese Medicine; and finally, the combination of conventional drug and acupuncture, and then determine which therapy is the most suitable for patients with COPD.
Read the detailed description
COPD, characterized by progressive airflow obstruction, airway inflammation, and systemic effects or comorbidities, is a leading cause of morbidity and mortality and is projected to be the third leading cause of death worldwide by 2030. Since breathlessness, exercise limitation and health status impairment broadly exist in COPD patients, effective management should be based on an individualized assessment of disease in order to reduce both current symptoms, which involves relieving symptoms, improving exercise tolerance and health status. At present, although appropriate pharmacologic therapy can relieve COPD symptoms, reduce the frequency and severity of exacerbations, and improve health status and exercise tolerance, its cost and adverse effects can never be ignored.
Acupuncture, an important part of traditional Chinese Medicine, has been used for thousands of years in treating many painful and non-painful conditions. To date, it has become popular and widely practiced in many countries around the world. In the past two decades, acupuncture research has grown markedly, in both the proportion of randomized clinical trials (RCTs) and the impact factor of journals. Evidences from both clinicians and patients suggest that there is some beneficial effect of acupuncture on COPD.
At present, there are many therapies available for patients with COPD, it is difficult for us to identify the most suitable therapy. Thus, this study aims to compare the efficacy of conventional drug, acupuncture and the combination of conventional drug and acupuncture, and then determine which is the most suitable therapy, providing a scientific basis for clinical decision.
This is a multi-center, randomized, controlled trial to compare the efficacy of three therapies for patients with COPD. After a 14-day run-in period, 150 subjects will be randomly assigned to one of the three therapies (conventional drug, acupuncture, and the combination of conventional drug and acupuncture) for 12 weeks treatment. After the treatment period, subjects in three arms will be followed up for 12 weeks. The primary outcomes will include exercise capacity (6MWD) and St. George's Respiratory Questionnaire (SGRQ), and secondary outcomes dyspnea (mMRC), acute exacerbation, lung function, quality of life (COPD assessment test, clinical symptom assessment questionnaire, COPD-PRO and EQ-5D) and health economics.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Acupuncture, Conventional drug, Acupuncture plus conventional drug
- Keywords
- Pulmonary Disease, Chronic Obstructive, Acupuncture Therapy, Humans
- 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.
AcupunctureOther
Feishu (BL13), Dazhui (DU14) and Fengmen (BL12) will be selected as main acupoints. There are four groups of acupoints: Taiyuan (LU9) and Zusanli (ST36) for Qi deficiency of the lung ZHEGN, Taiyuan (LU9), Pishu (BL20) and Zusanli (ST36) for Qi deficiency of the lung and spleen ZHEGN, Taiyuan (LU9), Shenshu (BL23) and Zusanli (ST36) for Qi deficiency of the lung and kidney ZHEGN, and Gaohuang (BL43), Shenshu (BL23), Taixi (KI3) and Guanyuan (RN4) for Qi and Yin deficiency of the lung and kidney ZHEGN. Besides, acupoints for specific symptoms will also be considered. Hwato Sterile Acupuncture Needles For Single Use (Hwato®, Suzhou Hua Tuo Medical Instruments Co., Ltd.) size in 0.30*25 mm, 0.30*40 mm or 0.30*50 mm will be used 3 times weekly for 12 weeks.
Conventional drugDrug
Also called Salbutamol Sulphate Inhalation Aerosol (Ventolin®), Tiotropium Bromide Powder for Inhalation (Spiriva®), Fluticasone Propionate Powder for Inhalation (Seretide®)
Salbutamol Sulphate Inhalation Aerosol (Ventolin®, GlaxoSmithKline Australia Pty Ltd.), 100 μg/press, 200 press, 100 μg each time (when needed), no more than 8 press daily for 12 weeks.
Tiotropium Bromide Powder for Inhalation (Spiriva®, Boehringer Ingelheim International GmbH), 18 μg/capsule, 10 capsule, 18 μg each time, once daily for 12 weeks.
Fluticasone Propionate Powder for Inhalation (Seretide®, Laboratoire GlaxoSmithKline), 50ug/250μg/inhalation, 60 inhalations, 50ug/250μg each time, twice daily for 12 weeks.
Acupuncture plus conventional drugOther
Both acupuncture and conventional drug will be used for 12 weeks treatment.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Patients in this arm will receive acupuncture. Receives: Other: Acupuncture |
| Conventional drug | Experimental | Patients will be individually divided into Group A, Group B, Group C and Group D according to GOLD 2017. For Group A, Salbutamol Sulphate Inhalation Aerosol (Ventolin®, GlaxoSmithKline Australia Pty Ltd) will be used. For Group B and Group C, Tiotropium Bromide Powder for Inhalation (Spiriva®, Boehringer Ingelheim International GmbH) will be used. As for Group D, Tiotropium Bromide Powder for Inhalation (Spiriva®, Boehringer Ingelheim International GmbH) or Fluticasone Propionate Powder for Inhalation (Seretide®, Laboratoire GlaxoSmithKline) will be used. Receives: Drug: Conventional drug |
| Acupuncture plus conventional drug | Experimental | Patients in this arm will receive both acupuncture and conventional drug. Receives: Other: Acupuncture plus conventional drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
6MWD
6-minute walk test will be conducted to assess exercise capacity.
Measured: Change from baseline 6MWD at week 4, week 8, week 12 of the treatment phase, and week 12 of the follow-up phase.
SGRQ
St. George's Respiratory Questionnaire (SGRQ) will be used to assess quality of life.
Measured: Change from baseline SGRQ score at week 12 of the treatment phase and week 12 of the follow-up phase.
Secondary outcomes (8)
mMRC
The modified Medical Research Council dyspnoea scale (mMRC) will be used to assess severity of dyspnea.
Measured: Change from baseline mMRC score at week 4, week 8, week 12 of the treatment phase, and week 12 of the follow-up phase.
Frequency of acute exacerbation
Frequency of acute exacerbation will be recorded.
Measured: Change from baseline frequency of acute exacerbation at week 4, week 8, week 12 of the treatment phase, and week 12 of the follow-up phase.
Lung function
Spirometry will be conducted to assess lung function.
Measured: Change from baseline lung function at week 12 of the treatment phase and week 12 of the follow-up phase.
CAT
COPD assessment test (CAT) will be used to assess quality of life.
Measured: Change from baseline CAT score at week 12 of the treatment phase and week 12 of the follow-up phase.
Clinical symptom assessment questionnaire
Clinical symptom assessment questionnaire of COPD will be used to assess symptom.
Measured: Change from baseline clinical symptom assessment questionnaire score at week 12 of the treatment phase and week 12 of the follow-up phase.
COPD-PRO
COPD patient-reported outcome scale (COPD-PRO) will be used to assess quality of life.
Measured: Change from baseline COPD-PRO score at week 12 of the treatment phase and week 12 of the follow-up phase.
EQ-5D
EuroQol 5D (EQ-5D) will be used to assess quality of life.
Measured: Change from baseline EQ-5D score at week 12 of the treatment phase and week 12 of the follow-up phase.
Health economics
Cost of the treatment phase and follow-up phase will be recorded.
Measured: Up to week 12 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 posted30 May 2017
- Study startMay 2017 (estimated)
- Primary completionMay 2018 (estimated)
- Study completionDec 2018 (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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suyun Li, Professor, Study chair, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03169504
- Sponsor's protocol ID
- Acupuncture for COPD
- Status last verified
- May 2017
- First submitted
- 21 May 2017
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li J, Xie Y, Wang Y, Wu L, Yu X, Bai L, Shao S, Zhou M, Zhang M, Yu X, Han W, Li X, Chen T. Effect of acupuncture on patients with chronic obstructive pulmonary disease: A multicenter randomized controlled trial. Complement Ther Med. 2025 May;89:103146. doi: 10.1016/j.ctim.2025.103146. Epub 2025 Feb 14.
PubMed 39956529
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupuncture on Patients With Chronic Obstructive Pulmonary Disease: a Multi-center, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT03169504
- Acronym / sponsor ID
- Acupuncture for COPD
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Pulmonary Disease, Chronic Obstructive, Acupuncture Therapy, Humans
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- May 2017 (estimated)
- Primary completion
- May 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 30 May 2017 (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.
This study aims to compare the efficacy of three therapies for chronic obstructive pulmonary disease (COPD) patients: one, conventional drug based on Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017 and Chinese Medical Association Guidelines; another, acupuncture, an important part of traditional Chinese Medicine; and finally, the combination of conventional drug and acupuncture, and then determine which therapy is the most suitable for patients with COPD.
Detailed description
COPD, characterized by progressive airflow obstruction, airway inflammation, and systemic effects or comorbidities, is a leading cause of morbidity and mortality and is projected to be the third leading cause of death worldwide by 2030. Since breathlessness, exercise limitation and health status impairment broadly exist in COPD patients, effective management should be based on an individualized assessment of disease in order to reduce both current symptoms, which involves relieving symptoms, improving exercise tolerance and health status. At present, although appropriate pharmacologic therapy can relieve COPD symptoms, reduce the frequency and severity of exacerbations, and improve health status and exercise tolerance, its cost and adverse effects can never be ignored.
Acupuncture, an important part of traditional Chinese Medicine, has been used for thousands of years in treating many painful and non-painful conditions. To date, it has become popular and widely practiced in many countries around the world. In the past two decades, acupuncture research has grown markedly, in both the proportion of randomized clinical trials (RCTs) and the impact factor of journals. Evidences from both clinicians and patients suggest that there is some beneficial effect of acupuncture on COPD.
At present, there are many therapies available for patients with COPD, it is difficult for us to identify the most suitable therapy. Thus, this study aims to compare the efficacy of conventional drug, acupuncture and the combination of conventional drug and acupuncture, and then determine which is the most suitable therapy, providing a scientific basis for clinical decision.
This is a multi-center, randomized, controlled trial to compare the efficacy of three therapies for patients with COPD. After a 14-day run-in period, 150 subjects will be randomly assigned to one of the three therapies (conventional drug, acupuncture, and the combination of conventional drug and acupuncture) for 12 weeks treatment. After the treatment period, subjects in three arms will be followed up for 12 weeks. The primary outcomes will include exercise capacity (6MWD) and St. George's Respiratory Questionnaire (SGRQ), and secondary outcomes dyspnea (mMRC), acute exacerbation, lung function, quality of life (COPD assessment test, clinical symptom assessment questionnaire, COPD-PRO and EQ-5D) and health economics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Other: AcupuncturePatients in this arm will receive acupuncture. |
| Conventional drug | Experimental | Drug: Conventional drugPatients will be individually divided into Group A, Group B, Group C and Group D according to GOLD 2017. For Group A, Salbutamol Sulphate Inhalation Aerosol (Ventolin®, GlaxoSmithKline Australia Pty Ltd) will be used. For Group B and Group C, Tiotropium Bromide Powder for Inhalation (Spiriva®, Boehringer Ingelheim International GmbH) will be used. As for Group D, Tiotropium Bromide Powder for Inhalation (Spiriva®, Boehringer Ingelheim International GmbH) or Fluticasone Propionate Powder for Inhalation (Seretide®, Laboratoire GlaxoSmithKline) will be used. |
| Acupuncture plus conventional drug | Experimental | Other: Acupuncture plus conventional drugPatients in this arm will receive both acupuncture and conventional drug. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A diagnosis of COPD with classification of airflow limitation severity from GOLD 1 to GLOD 3 according to GOLD 2017.
- Syndrome differentiation meets criteria of Qi deficiency of the lung ZHEGN, Qi deficiency of the lung and spleen ZHEGN, Qi deficiency of the lung and kidney ZHEGN, or Qi and Yin deficiency of the lung and kidney ZHEGN.
- Age ranges from 40 years to 80 years.
Key exclusion criteria (12 listed)
- Pregnant and lactating women.
- Patients with severe cardiovascular and cerebrovascular diseases.
- Patients with severe liver and kidney disease.
- Patients with bronchiectasis, active pulmonary tuberculosis, pulmonary embolism or other severe respiratory diseases.
- Patients with tumor after resection, radiotherapy or chemotherapy in the past 5 years.
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 |
|---|---|---|
| AcupunctureFeishu (BL13), Dazhui (DU14) and Fengmen (BL12) will be selected as main acupoints. There are four groups of acupoints: Taiyuan (LU9) and Zusanli (ST36) for Qi deficiency of the lung ZHEGN, Taiyuan (LU9), Pishu (BL20) and Zusanli (ST36) for Qi deficiency of the lung and spleen ZHEGN, Taiyuan (LU9), Shenshu (BL23) and Zusanli (ST36) for Qi deficiency of the lung and kidney ZHEGN, and Gaohuang (BL43), Shenshu (BL23), Taixi (KI3) and Guanyuan (RN4) for Qi and Yin deficiency of the lung and kidney ZHEGN. Besides, acupoints for specific symptoms will also be considered. Hwato Sterile Acupuncture Needles For Single Use (Hwato®, Suzhou Hua Tuo Medical Instruments Co., Ltd.) size in 0.30*25 mm, 0.30*40 mm or 0.30*50 mm will be used 3 times weekly for 12 weeks. | Other | Acupuncture |
| Conventional drugAlso: Salbutamol Sulphate Inhalation Aerosol (Ventolin®), Tiotropium Bromide Powder for Inhalation (Spiriva®), Fluticasone Propionate Powder for Inhalation (Seretide®)Salbutamol Sulphate Inhalation Aerosol (Ventolin®, GlaxoSmithKline Australia Pty Ltd.), 100 μg/press, 200 press, 100 μg each time (when needed), no more than 8 press daily for 12 weeks. Tiotropium Bromide Powder for Inhalation (Spiriva®, Boehringer Ingelheim International GmbH), 18 μg/capsule, 10 capsule, 18 μg each time, once daily for 12 weeks. Fluticasone Propionate Powder for Inhalation (Seretide®, Laboratoire GlaxoSmithKline), 50ug/250μg/inhalation, 60 inhalations, 50ug/250μg each time, twice daily for 12 weeks. | Drug | Conventional drug |
| Acupuncture plus conventional drugBoth acupuncture and conventional drug will be used for 12 weeks treatment. | Other | Acupuncture plus conventional drug |
Primary outcome
6MWD
Time frame: Change from baseline 6MWD at week 4, week 8, week 12 of the treatment phase, and week 12 of the follow-up phase.
6-minute walk test will be conducted to assess exercise capacity.
SGRQ
Time frame: Change from baseline SGRQ score at week 12 of the treatment phase and week 12 of the follow-up phase.
St. George's Respiratory Questionnaire (SGRQ) will be used to assess quality of life.
8 secondary outcomes
mMRC
Time frame: Change from baseline mMRC score at week 4, week 8, week 12 of the treatment phase, and week 12 of the follow-up phase.
Frequency of acute exacerbation
Time frame: Change from baseline frequency of acute exacerbation at week 4, week 8, week 12 of the treatment phase, and week 12 of the follow-up phase.
Lung function
Time frame: Change from baseline lung function at week 12 of the treatment phase and week 12 of the follow-up phase.
CAT
Time frame: Change from baseline CAT score at week 12 of the treatment phase and week 12 of the follow-up phase.
Clinical symptom assessment questionnaire
Time frame: Change from baseline clinical symptom assessment questionnaire score at week 12 of the treatment phase and week 12 of the follow-up phase.
COPD-PRO
Time frame: Change from baseline COPD-PRO score at week 12 of the treatment phase and week 12 of the follow-up phase.
EQ-5D
Time frame: Change from baseline EQ-5D score at week 12 of the treatment phase and week 12 of the follow-up phase.
Health economics
Time frame: Up to week 12 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 30 May 2017.
- Derived from this study: PubMed 39956529Li J, Xie Y, Wang Y, Wu L, Yu X, Bai L, Shao S, Zhou M, Zhang M, Yu X, Han W, Li X, Chen T. Effect of acupuncture on patients with chronic obstructive pulmonary disease: A multicenter randomized controlled trial. Complement Ther Med. 2025 May;89:103146. doi: 10.1016/j.ctim.2025.103146. Epub 2025 Feb 14.
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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.
Suyun Li, Professor study chair
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acupuncture, Conventional drug and Acupuncture plus conventional drug in people with Pulmonary Disease, Chronic Obstructive, run by Henan University of Traditional Chinese Medicine at 1 site in China.
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 3 inclusion and 12 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 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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?
6MWD (time frame: Change from baseline 6MWD at week 4, week 8, week 12 of the treatment phase, and week 12 of the follow-up 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 NCT03169504, 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 May 2017.