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

• Status: Unknown status
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henan University of Traditional Chinese Medicine
• Treatments: Albuterol; Fluticasone; Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Fluticasone-Salmeterol Drug Combination; Formoterol Fumarate; Salmeterol Xinafoate; Xhance

Criteria

Inclusion Criteria:

• A confirmed diagnosis of mild to very severe COPD.

• medically stable

• Age between 18 and 80 years.

• Syndrome differentiation belongs to Syndrome of lung-qi deficiency, Syndrome of deficiency of pulmonic-splenic qi, Syndrome of insufficiency of qi of the lung and kidney, syndrome of insufficiency of qi and yin of the lung and kidney.

• 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 .

• Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within the last 5 years.

• Current respiratory disorders other than COPD (e.g., bronchiectasis, tuberculosis, lung fibrosis, pulmonary thromboembolic).

• Complicated with heart failure (NYHA Class III or IV),or myocardial infarction within six months ,or unstable hemodynamics.

• 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.