Effect of Acupuncture on Patients With Chronic Obstructive Pulmonary Disease

NCT03169504 | Unknown Phase 3 DMC

• 1 other identifier: Acupuncture for COPD
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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 Chinese Medicine; and finally, the combination of conventional drug and acupuncture, and then determine which therapy is the most suitable for patients with COPD.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Pulmonary Disease, Chronic Obstructive; Acupuncture Therapy; Humans

Outcome Measures

Primary Outcomes (2)

• 6MWD

  6-minute walk test will be conducted to assess exercise capacity.

  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.

  Change from baseline SGRQ score at week 12 of the treatment phase and week 12 of the follow-up phase.

Secondary Outcomes (8)

• mMRC

  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

  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

  Change from baseline lung function at week 12 of the treatment phase and week 12 of the follow-up phase.

• CAT

  Change from baseline CAT score at week 12 of the treatment phase and week 12 of the follow-up phase.

• Clinical symptom assessment questionnaire

  Change from baseline clinical symptom assessment questionnaire score at week 12 of the treatment phase and week 12 of the follow-up phase.

Study Arms (3)

Acupuncture

EXPERIMENTAL

Patients in this arm will receive acupuncture.

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.

Drug: Conventional drug

Acupuncture plus conventional drug

EXPERIMENTAL

Patients in this arm will receive both acupuncture and conventional drug.

Other: Acupuncture plus conventional drug

Interventions

Acupuncture OTHER

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.

Acupuncture

Conventional drug DRUG

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.

Also known as: Salbutamol Sulphate Inhalation Aerosol (Ventolin®), Tiotropium Bromide Powder for Inhalation (Spiriva®), Fluticasone Propionate Powder for Inhalation (Seretide®)

Conventional drug

Acupuncture plus conventional drug OTHER

Both acupuncture and conventional drug will be used for 12 weeks treatment.

Acupuncture plus conventional drug

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Henan University of Traditional Chinese Medicine: lead

Study Sites (1)

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Zhengzhou, Henan, 450000, China

Location

Related Publications (1)

• 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.

  PMID: 39956529 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Acupuncture Therapy; Albuterol; Inhalation; Tiotropium Bromide; Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Salmeterol Xinafoate; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Suyun Li, Professor

  The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

  STUDY CHAIR

Central Study Contacts

Yang Xie, Doctor

CONTACT

86-371-66248624; xieyanghn@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2017
• First Posted: May 30, 2017
• Study Start: May 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 30, 2017

Record last verified: 2017-05

Locations

CN (1)