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 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT00838851
Eligibility Criteria:
Inclusion Criteria:
* Inclusion: Healthy, non-allergic, non-asthmatic 18-50 year old males and females with a \< 0.5 pack year history of tobacco use who have a negative allergy skin test, normal lung function, defined as (Knudsen 1976/1984 predicted set):
1. FVC of \> 80 % of that predicted for gender, ethnicity, age and height
2. FEV1 of \> 80 % of that predicted for gender, ethnicity, age and height
3. FEV1/FVC ratio of \> 75% of that predicted for gender, ethnicity , age and height
* Oxygen saturation of \> 94 %,
* Normal blood pressure (Systolic between 150 - 90, Diastolic between 90-60 mm Hg),
* Symptom Score no greater than 6 (out of a possible 24) for total symptom score with a value no greater than 2 for any one score. No score may be greater than 2,
* Negative methacholine inhalation challenge.
* On the day of a challenge, body temperature must be no greater than 37.8 degrees, measured orally.
Exclusion Criteria:
* A history of significant chronic illnesses (to include diabetes, autoimmune diseases, immunodeficiency state, known ischemic heart disease, chronic respiratory diseases such as chronic obstructive pulmonary disease or asthma, hypertension).
* Allergy to any medications which may be used in the course of this study (albuterol, acetaminophen, aspirin or non-steroidal anti-inflammatory agents, corticosteroids, lactose).
* Positive pregnancy test within 48 hours of the time of challenge.
* Medications which may impact the results of the endotoxin challenge, interfere with any other medications potentially used in the study (to include steroids, beta antagonists, non-steroidal anti-inflammatory agents) or suggest an ongoing illness (such as antibiotics).
* Acute, non-chronic, medical conditions, including (but not limited to) pneumonia or bronchitis requiring antibiotics, febrile illnesses, flu-like symptoms must be totally resolved symptomatically for 2 weeks.
* Unspecified illnesses, which in the judgment of the investigator increase the risk associated with endotoxin inhalation challenge, will be a basis for exclusion.
* Persons employed within the past 6 months in an occupation with high risk for endotoxin exposure (specifically persons working in a swine confinement facility, cotton storage or grain storage site)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT00838851
Study Brief:
Protocol Section:
NCT00838851