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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02270424
• Other study ID #: TCM for severe COPD
• Status: Not yet recruiting
• Phase: Phase 3
• First received: October 17, 2014
• Last updated: October 17, 2014
• Start date: October 2014
• Est. completion date: December 2016

Study information

• Verified date: October 2014
• Source: Henan University of Traditional Chinese Medicine
• Contact: Xueqing Yu, Doctor
• Phone: +86 371 66248624
• Email: yxqshi[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology of the People´s Republic of China
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 564
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Henan University of Traditional Chinese Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The frequency of exacerbation		Change from Baseline in the frequency of exacerbation at the week13, 26, 39 and 52 of the treatment phase, the week 13, 26, 39 and 52 of the followup phase	No
Secondary	Mortality	The mortality of COPD and all-cause mortality will be calculated.	52 Weeks of the treatment phase and the 52 Weeks of the followup phase	No
Secondary	Forced expiratory volume in one second	FEV1 is the amount of air that can be exhaled in one second. A positive change from baseline in FEV1 indicates improvement in lung function.	Change from Baseline in the one second (FEV1) at the week13, 26, 39 and 52 of the treatment phase, the week 13, 26, 39 and 52 of the followup phase.	No
Secondary	Dyspnea	Using Modified Medical Research Council ( MMRC) scale to assess a patient's level of dyspnea. The MMRC scale is a simple grading system that scored from 0 (less severe) to 4 (severe).	Change from Baseline in MMRC at the week13, 26, 39 and 52 of the treatment phase, the week 13, 26, 39 and 52 of the followup phase	No
Secondary	6 Minutes Walking Distance Test ( 6MWD)		Change from Baseline in the 6MWD at the week 13, 26, 39 and 52 of the treatment phase, the week 13, 26, 39 and 52 of the followup phase.	No
Secondary	Quality of life	Using three instruments, COPD Assessment Test ( CAT) , Short Form 36-Item Health Survey (SF-36) and patient reported outcome for chronic obstructive pulmonary disease (COPD-PRO), to asses the impact of COPD on a person's life, and how this changes over time.	Change from Baseline in the CAT, SF-36 and COPD-PRO at the week 13, 26, 39 and 52 of the treatment phase, the week 13, 26, 39 and 52 of the followup phase.	No
Secondary	Effectiveness satisfaction with treatment	Using the effectiveness satisfaction questionnaire of chronic obstructive pulmonary disease (ESQ-COPD) to evaluate COPD patients' satisfaction with their treatment over time.	Change from Baseline in the ESQ-COPD at the week 13, 26, 39 and 52 of the treatment phase, the week 13, 26, 39 and 52 of the followup phase.	No