Effect of Traditional Chinese Medicine on Outcomes in Patients With Severe / Very Severe COPD

NCT ID: NCT02270424

Last Updated: 2014-10-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 564 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-12-31

Brief Summary

The aim of this study is to compare the effectiveness of two treatments for severe / very severe COPD patients: one, conventional medicine based on 2013 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines; the other, TCM treatments and conventional medicine, which have been evaluated and have certain effect.

Detailed Description

Patients with severe or very severe COPD are more likely to suffer repeated exacerbations and more rapidly declining lung function generating increased risk of death and time to a COPD related hospitalization. Although many therapies exist and are being developed to relieve symptoms and reduce mortality in COPD, most have only been studied in moderate to very severe COPD. There are few clinical trials to compare therapeutic alternatives in severe and very sever COPD. Furthermore, some randomized controlled trials on comprehensive Traditional Chinese medicine (TCM) interventions, especially based on the TCM patterns, have been the certain evidence for showing definite effect for COPD patients. In addition, a study about the effect of TCM on outcomes in mild and moderate COPD patients has been in progress and will be carried out in December 2014 (NCT01486186). Hence, corresponding to the mild to moderate COPD patients, The this study aims to evaluate the effectiveness of TCM on severe / very severe COPD patients.

This is a multi-center, randomized, double-blind, controlled study to evaluate the effectiveness of TCM on severe / very Severe COPD patients. Following a 14 day run-in period, approximately 564 subjects will be randomly assigned to conventional medicine treatment group, TCM and conventional medicine treatment group for 52 weeks. After the 52 weeks treatment period, subjects in two treatments arms will follow-up 52 weeks. The primary outcome measure is the frequency of exacerbations. The secondary efficacy measures include 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) . Safety will be assessed through the collection of adverse events. There will be a total of 9 study visits (baseline, the 13, 26, 39 and 52 weeks of the treatment, the 13, 26, 39 and 52 weeks of follow-up).

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Conventional medicine+ placebo TCM

Patients in this group will be given conventional medicine, Salmeterol / fluticasone based on the classes of medications recommended by 2011 GOLD and Chinese Treatment Guidelines for COPD, and three placebo TCM treatment, which are which are placebo Bufeijianpi granule, placebo Bufeiyishen granule and placebo Yiqizishen granule corresponding to the three traditional Chinese syndromes in sequence, which are syndrome of deficiency of pulmono-splenic qi, syndrome of insufficiency of qi of the lung and kidney, syndrome of insufficiency of qi and yin of the lung and kidney.

Group Type: EXPERIMENTAL

Salmeterol / fluticasone (Seretide®)

Intervention Type: DRUG

According to the revised 2013 GOLD, Salmeterol / fluticasone was used to severe and very severe COPD patients for 52weeks: Salmeterol / fluticasone (Seretide®, GlaxoSmithKline), 50/500 μg / dose, 60 inhalations. 50/500 μg each time, twice daily.

Placebo Bufeijianpi granule

Intervention Type: DRUG

According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of deficiency of pulmono-splenic qi will be given placebo Bufeijianpi granule, twice daily for 52 weeks for lower dosage.

Placebo Bufeiyishen granule

Intervention Type: DRUG

According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi of the lung and kidney will be given placebo Bufeiyishen granule, twice daily for 52 weeks for lower dosage.

Placebo Yiqizishen granule

Intervention Type: DRUG

According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi and yin of the lung and kidney will be given placebo Yiqizishen granule granule, twice daily for 52 weeks for lower dosage.

conventional medicine+ TCM

Patients in this group will receive Salmeterol / fluticasone based on the classes of medications recommended by 2011 GOLD and Chinese Treatment Guidelines for COPD, and three types of TCM treatment, which are Bufeijianpi granule, Bufeiyishen granule and Yiqizishen granule. A herbal extract twice daily for 52 weeks for lower dosage. The three granules are corresponding to the three traditional Chinese syndromes in sequence, which are syndrome of deficiency of pulmono-splenic qi, syndrome of insufficiency of qi of the lung and kidney, syndrome of insufficiency of qi and yin of the lung and kidney.

Group Type: EXPERIMENTAL

Salmeterol / fluticasone (Seretide®)

Intervention Type: DRUG

According to the revised 2013 GOLD, Salmeterol / fluticasone was used to severe and very severe COPD patients for 52weeks: Salmeterol / fluticasone (Seretide®, GlaxoSmithKline), 50/500 μg / dose, 60 inhalations. 50/500 μg each time, twice daily.

Bufeijianpi granule

Intervention Type: DRUG

According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of deficiency of pulmono-splenic qi will be given Bufeijianpi granule, twice daily for 52 weeks for lower dosage.

Bufeiyishen granule

Intervention Type: DRUG

According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi of the lung and kidney will be given Bufeiyishen granule, twice daily for 52 weeks for lower dosage.

Yiqizishen granule

Intervention Type: DRUG

According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi and yin of the lung and kidney will be given Yiqizishen granule granule, twice daily for 52 weeks for lower dosage.

Interventions

Salmeterol / fluticasone (Seretide®)

According to the revised 2013 GOLD, Salmeterol / fluticasone was used to severe and very severe COPD patients for 52weeks: Salmeterol / fluticasone (Seretide®, GlaxoSmithKline), 50/500 μg / dose, 60 inhalations. 50/500 μg each time, twice daily.

Intervention Type: DRUG

Bufeijianpi granule

According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of deficiency of pulmono-splenic qi will be given Bufeijianpi granule, twice daily for 52 weeks for lower dosage.

Intervention Type: DRUG

Bufeiyishen granule

According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi of the lung and kidney will be given Bufeiyishen granule, twice daily for 52 weeks for lower dosage.

Intervention Type: DRUG

Yiqizishen granule

According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi and yin of the lung and kidney will be given Yiqizishen granule granule, twice daily for 52 weeks for lower dosage.

Intervention Type: DRUG

Placebo Bufeijianpi granule

According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of deficiency of pulmono-splenic qi will be given placebo Bufeijianpi granule, twice daily for 52 weeks for lower dosage.

Intervention Type: DRUG

Placebo Bufeiyishen granule

According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi of the lung and kidney will be given placebo Bufeiyishen granule, twice daily for 52 weeks for lower dosage.

Intervention Type: DRUG

Placebo Yiqizishen granule

According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi and yin of the lung and kidney will be given placebo Yiqizishen granule granule, twice daily for 52 weeks for lower dosage.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• A confirmed diagnosis of severe to very severe COPD.
• medically stable
• Age between 40 and 80 years.
• Syndrome differentiation belongs to syndrome of deficiency of pulmonosplenic qi, syndrome of insufficiency of qi of the lung and kidney, syndrome of insufficiency of qi and yin of the lung and kidney.
• with a two-week wash-out period prior to randomization
• Without participations in other interventional trials in the previous one month.
• With the informed consent signed.

Exclusion Criteria

• Pregnant or breast-feeding women.
• Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
• Current respiratory disorders other than COPD (e.g., bronchiectasis, bronchial asthma, tuberculosis, lung fibrosis, pulmonary thromboembolic, diffuse panbronchiolitis).
• Complicated with a neuromuscular disorder, which affected the respiration.
• Complicated with heart failure (NYHA Class III or IV),or myocardial infarction within six months ,or unstable hemodynamics.
• Complicated with malignancy, congenital or acquired immune deficiency.
• Complicated with serious hepatic and renal diseases (liver cirrhosis, portal hypertension, bleeding of varicose veins, dialysis, or renal transplantation).
• Participating in other trials or allergic to the used medicine.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiansheng Li, Doctor

Role: STUDY_CHAIR

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Central Contacts

Xueqing Yu, Doctor

Role: CONTACT

yxqshi@163.com

+86 371 66248624

References

Li J, Xie Y, Wang M, Li S, Yu X, Zhang N, Zhu Z, Zhang W, Feng J, Sun Z, Lin L, Sun Z, Zhang H, Yu X. Effect of traditional Chinese medicine combined with conventional Western medicine for patients with severe/very severe chronic obstructive pulmonary disease: a multi-center, randomized, double-blind, controlled study. Chin Med. 2025 May 20;20(1):66. doi: 10.1186/s13020-025-01117-x.

Reference Type: DERIVED

PMID: 40394700 (View on PubMed)

Other Identifiers

TCM for severe COPD

Identifier Type: -

Identifier Source: org_study_id