Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-24 @ 11:02 PM
NCT ID:
NCT00147069
Eligibility Criteria:
Inclusion Criteria:
Asthmatic patients:
1. Age 21-79 years of both sexes (females will be taking adequate contraceptive measures).
2. Increase in FEV1 \>15% and \>200ml following beta2 agonist inhalation, either at the time of study or previously documented
COPD patients:
1. Stable patients with a post-salbutamol FEV1 30-70% predicted normal of \>1L
2. Increase in FEV1 \< 15% and \< 200 ml following beta2 agonist inhalation, either at the time of study or previously documented
3. Age 21-79 years of both sexes (females will be taking adequate contraceptive measures )
4. Smokers
5. No history of allergic or respiratory disease.
Normal Volunteers
1. Age 21-79 years of both sexes (females will be taking adequate contraceptive measures )
2. Non-smokers
3. Normal lung function
4. No upper respiratory tract infection within the last 4 weeks
5. No history of allergic or respiratory disease.
Healthy Smokers 1. Age 21-79 years of both sexes (females will be taking adequate contraceptive measures ) 2. Smokers 3. Normal lung function 4. No upper respiratory tract infection within the last 4 weeks
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Exclusion Criteria:
1. Asthmatic patients with FEV1 less than 40% predicted value
2. Alcohol abuse
3. Any history or evidence of hepatic, cardiovascular or renal disease
4. Any history or evidence of neuropsychiatric disease
5. Drug abuse or any other condition associated with poor compliance
6. Pregnancy or breast feeding
7. Patients are unable to provide written informed consent
COPD patients:
1\. Any other active lung diseases 2. Upper respiratory infection within the last 4 weeks 3. Pregnancy or breast feeding 4. Any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study 5. Subjects unable to give informed consent
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Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
70 Years
Study:
NCT00147069
Study Brief:
Protocol Section:
NCT00147069