Small Airways Evaluation and Treatment

• Status: Unknown status
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Chronic obstructive pulmonary disease (COPD) is a common disease , and characterized by progressive development of airflow limitation. Small airway disease (obstructive bronchitis) and lung parenchyma damage (emphysema) are the main mechanisms of chronic airflow limitation. Research shows that small airway resistance increased by 4-40 times in COPD patients, and become the main part of the airflow obstruction. Impulse oscillation system (IOS) is able to measure the total airway resistance, the central airway resistance and the peripheral airway resistance, which is now widely used to assess small airway function in COPD patients. While High resolution CT (HRCT) is easy to operate and its images are intuitive. Meanwhile it can measure the proportion of emphysema, the airway diameter and the thickness of airway wall. Both of these two tests have great significance in small airway evaluation. Chronic obstructive pulmonary disease with acute exacerbation (AECOPD) is an acute onset process, which is characterized by the aggravation of respiratory symptoms and deterioration of pulmonary function. However, the structural and functional changes of small airway in AECOPD are not clear. Inhalation drugs are the main treatment for stable COPD , and inhaled corticosteroid（ICS）+long-acting beta2-agonist（LABA） are used to treat patients with severe and severe airflow limitation. The particles in traditional inhalation drugs are larger and mainly deposited in large airways, and their effects on small airway function are relatively small.

The objectives of the investigators study are COPD patients. The study is divided into two parts, that is the part of AECOPD patients and the part of stable patients . Patients with AECOPD are arranged to take HRCT and IOS test to assess the small airway changes.Patients with stable COPD are randomized to take either beclomethasone / formoterol (particle diameter for 1.4-1.5um) or budesonide / formoterol (3.2um) for three months. The structure and function changes of small airway in different stage will be evaluated and the efficacy of these two drugs is to be compared. This study is expected to highlight the investigators understanding on the role of small airways in COPD, and provide a guideline to clinical standardized treatment as well as evaluation of patients' conditions.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhujiang Hospital
• Treatments: Beclomethasone; Budesonide; Formoterol Fumarate

Criteria

Inclusion Criteria:

• Clinical diagnosis of chronic obstructive pulmonary disease;

• More than 40 years;

Exclusion Criteria:

• asthma , or combined with bronchiectasia，pneumonia in the right upper lobe;

• Malignant tumor in the lung or other parts of the body;

• Uncontrolled hypertension (systolic blood pressure >200 mmHg, diastolic blood pressure >100 mmHg);

• Severe cardiac insufficiency, arrhythmia;