Pharmacological Effect of Lysozyme for Chronic Obstructive Pulmonary Disease and Asthma With Sputum Symptom
Phase 4
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD) and Asthma
- Registration Number
- JPRN-jRCT1080222009
- Lead Sponsor
- Eisai Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
For COPD:
Diagnosis of COPD
Forced expiratory volume in 1 second (FEV1) of <80% of the predicted value
Ratio of FEV1 to forced vital capacity (FVC) of <70%
Symptom of expectorated sputum
Brinkman index 200 or more
Smoking history
For Asthma:
Diagnosed partly controlled by global initiative for asthma
Symptom of expectorated sputum
Scored between 20 to 24 by ACT (Asthma Control Test)
Exclusion Criteria
Patients with egg allergy
Patients with domiciliary oxygen therapy
Patients with pneumonia or pulmonary tuberculosis
Patients with severe cardiovascular disorder, severe kidney disorder, severe hepatic disorder, severe hematological disorder
Patients with cancer
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy<br><br>Peripheral airway resistance and reactance measured by Impulse oscillometry system, and NO concentration<br><br>Change of several inflammatory or biochemical marker concentration in inducted sputum
- Secondary Outcome Measures
Name Time Method