Asthma Clinical Trial
Official title:
Pharmacological Effect of Lysozyme for Chronic Obstructive Pulmonary Disease and Asthma With Sputum Symptom: a Randomised Placebo-controlled Study
Verified date | July 2014 |
Source | Eisai Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Ministry of Health, Labor and Welfare |
Study type | Interventional |
The aim of this study was to assess the effectiveness for small airway inflammation of 4 weeks lysozyme administration in Chronic Obstructive Pulmonary Disease (COPD) and/or asthma.
Status | Completed |
Enrollment | 48 |
Est. completion date | January 2014 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 84 Years |
Eligibility |
Inclusion criteria: For COPD: - Over 20 years of age and below 85 years of age - Smoking history - Brinkman index 200 or more - 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 For Asthma - Over 20 years of age and below 85 years of age - Scored between 20 to 24 by ACT (Asthma Control Test) - Symptom of expectorated sputum - Diagnosed partly controlled by global initiative for asthma Exclusion criteria: - Egg allergy - Domiciliary oxygen therapy - Pneumonia or pulmonary tuberculosis - Patients with severe cardiovascular disorder, severe kidney disorder, severe hepatic disorder, severe hematological disorder - Cancer |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Eisai Co., Ltd. |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of several inflammatory or biochemical marker concentration in inducted sputum | 8 weeks (2 periods each lasting 4 weeks) | No | |
Primary | Peripheral airway resistance and reactance measured by Impulse oscillometry system, and NO concentration. | 8 weeks (2 periods each lasting 4 weeks) | No | |
Secondary | Monthly reduction in forced expiratory volume in 1 Second (FEV1) | 8 weeks (2 periods each lasting 4 weeks) | No | |
Secondary | Quality of life assessed by CAT (COPD Assessment Test) and ACT (Asthma Control Test) | 8 weeks (2 periods each lasting 4 weeks) | No |
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