A Randomized Comparative Effectiveness Research Trial of Three Treatments for COPD Patients

Summary

The aim of this study is to compare the effectiveness and economic evaluation of three treatments for Chronic Obstructive Pulmonary Disease (COPD) patients: one, conventional medicine based on 2011 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines; another, TCM treatments, which have been evaluated and have certain effect; and finally, combination of both conventional medicine and TCM treatment, then determine which treatment is the most suitable for COPD patients.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Salbutamol (Ventolin®)

According to the revised 2011 GOLD, patients will be divided into Group A, B, C, and D based on individualized assessment. Salbutamol was used to Group A patients for 26 weeks: Salbutamol (Ventolin®, GlaxoSmithKline) 100μg/dose, 200 inhalations. 100 μg each time (when needed), and the maximum dose is 8-12 inhalations a day.

DRUG

Formoterol (Oxis Turbuhaler®)

According to the revised 2011 GOLD, patients will be divided into Group A, B, C, and D based on individualized assessment. Formoterol was used to Group B patients for 26 weeks: Formoterol (Oxis Turbuhaler®, AstraZeneca), 4.5μg/ dose, 60 inhalations. 4.5μg each time, twice daily.

DRUG

Salmeterol / fluticasone (Seretide®)

According to the revised 2011 GOLD, patients will be divided into Group A, B, C, and D based on individualized assessment. Salmeterol / fluticasone was used to Group C patients and Group D patients for 26 weeks: Salmeterol / fluticasone (Seretide®, GlaxoSmithKline), 50/500 μg / dose, 60 inhalations. 50/500 μg each time, twice daily.

DRUG

Bufei granule

According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of lung-qi deficiency will be given Bufei granule, twice daily for 26 weeks for lower dosage.

DRUG

Bufeijianpi granule

According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of deficiency of pulmonic-splenic qi will be given Bufeijianpi granule, twice daily for 26 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 26 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, twice daily for 26 weeks for lower dosage.

DRUG

conventional medicine + TCM

Patients will be given the combination of conventional medicine (Salbutamol, Formoterol, Salmeterol / fluticasone, Salmeterol / fluticasone) and (Bufei granule, Bufeijianpi granule, Bufeiyishen granule and Yiqizishen granule) for 26 weeks.

Sponsors & Collaborators

• Henan University of Traditional Chinese Medicine

  lead OTHER

Principal Investigators

• Jiansheng Li, MD · The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-05-31

Primary Completion

2015-05-31

Completion

2015-05-31

Countries

• China

Study Locations