Eligibility Details:
Inclusion Criteria:
1. Age 18-45 years, inclusive, of both genders
2. Negative pregnancy test for females who are not s/p hysterectomy with oophorectomy
3. Forced expiratory volume at one second (FEV1) of at least 75% of predicted (without
use of bronchodilating medications for 12 hours), consistent with lung function of
persons with no more than mild intermittent or mild persistent asthma.
4. Oxygen saturation of <93% and blood pressure within the following limits: (Systolic
between 150-85 mmHg, Diastolic between 90-50 mmHg).
5. Ability to provide an induced sputum sample.
6. Subject must demonstrate a ≥10% increase in sputum neutrophils following inhaled WSP
exposure, when compared to baseline sputum (to be completed in a separate protocol).
7. Ability/willingness to discontinue inhaled corticosteroids, montelukast, and cromolyn
for 2 weeks without increased symptoms or increased need for beta agonist rescue
medication prior to screening and through the course of the study.
Exclusion Criteria
Patients who meet any of these criteria are not eligible for enrollment as study
participants:
1. Clinical contraindications:
1. Any chronic medical condition considered by the PI as a contraindication to the
exposure study including significant cardiovascular disease, diabetes, chronic
renal disease, chronic thyroid disease, history of chronic
infections/immunodeficiency.
2. Viral upper respiratory tract infection within 4 weeks of challenge.
3. Any acute infection requiring antibiotics within 4 weeks of exposure or fever of
unknown origin within 4 weeks of challenge.
4. Abnormal physical findings at the baseline visit, including but not limited to
abnormalities on auscultation, temperature of 37.8° C, Systolic BP > 150mm Hg or
< 85 mm Hg; or Diastolic BP > 90 mm Hg or < 50 mm Hg, or pulse oximetry
saturation reading less than 93%.
5. Physician directed emergency treatment for an asthma exacerbation within the
preceding 12 months.
6. Moderate or severe asthma
7. Exacerbation of asthma more than 2x/weeks which would be characteristic of a
person with moderate or severe persistent asthma as outlined in the current
National Asthma Education and Prevention Program (NAEPP) guidelines for diagnosis
and management of asthma
8. Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest
tightness) which would be characteristic of a person with moderate or severe
persistent asthma as outlined in the current NHLBI guidelines for diagnosis and
management of asthma (not to include prophylactic use of albuterol prior to
exercise).
9. Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not
during a clearly recognized viral induced asthma exacerbation) which would be
characteristic of a person of moderate or severe persistent asthma as outlined in
the current NHLBI guidelines for the diagnosis and management of asthma.
10. History of intubation for asthma
11. If there is a history of allergic rhinitis, subjects must be asymptomatic of
allergic rhinitis at the time of study enrollment.
12. Mental illness or history of drug or alcohol abuse that, in the opinion of the
investigator, would interfere with the participant's ability to comply with study
requirements.
13. Cigarette smoking > 1 pack per month
14. Unwillingness to use reliable contraception if sexually active (IUD, birth
control pills/patch, condoms).
15. Abnormal prothrombin time (PT) or activated partial thromboplastin time (aPTT)
values at screening or during the treatment period. Normal values will be those
published by the clinical lab (Labcorp, INC).
16. Use of immunosuppressive or anticoagulant medications including routine use of
NSAIDS. Oral contraceptives are acceptable, as are Antidepressants and other
medications may be permitted if, in the opinion of the investigator, the
medication will not interfere with the study procedures or compromise safety and
if the dosage has been stable for 1 month.
17. Orthopedic injuries or impediments that would preclude bicycle or treadmill
exercise.
18. Inability to avoid NSAIDS, Multivitamins, Vitamin C or E or herbal supplements.
19. Allergy/sensitivity to study drugs or their formulations
20. Known hypersensitivity to methacholine or to other parasympathomimetic agents
21. Unwillingness to avoid coffee, tea, cola drinks, chocolate, or other foods
containing caffeine after midnight on the days that methacholine challenge
testing is to be performed.
2. Pregnant/nursing women and children (< 18 years as this is age of majority in North
Carolina) will also be excluded since the risks associated with woodsmoke exposure to
the fetus or child, respectively, are unknown and cannot be justified for this
non-therapeutic protocol. Individuals over 45 years of age will not be included due to
the increased possibility of co-morbidities and need for prohibited medications.
3. Inability or unwillingness of a participant to give written informed consent.
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-no
