NCT02270424

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

A Multi-center, Randomized, Double-blind, Controlled Study to Evaluate the Effectiveness of on Severe / Very Severe COPD Patients

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 564 (estimated)
• Sponsor: Henan University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.
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.
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.
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.
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.
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.
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.

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2014-10-21
• Last updated: 2014-10-21