Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of North Carolina, Chapel Hill
With
National Heart, Lung, and Blood Institute (NHLBI)
Age
40–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Volunteers who meet all of the following criteria will be eligible for study participation:
1. Age 40-80 years, inclusive
2. Non-pregnant subjects must be either not sexually active, post-menopausal, surgically sterilized, or agree to use an appropriate "double barrier" method (such as diaphragm and condom), or must currently be using a prescribed transdermal, injection, implant, or oral contraceptive during study participation.
3. Forced expiratory volume in 1 second (FEV1) of 35-80% of predicted, inclusive, and FEV1/forced vital capacity (FVC) \< 70%
4. Produces mucus at least 2 days per week, on average
5. History of smoking (≥ 10 pack years) -
You may not be if
Volunteers will be excluded from the study if they meet any of the following criteria:
1. Uses oxygen continuously during daytime hours (nighttime use OK)
2. Requires \> 10mg per day of prednisone (or equivalent corticosteroid dose) chronically
3. Concomitant presence of congestive heart failure, active coronary syndromes, or other disease that in the opinion of the investigator would increase the risk resulting from participation
4. Recent change in respiratory medications, including acute antibiotic or systemic corticosteroid interventions within the last 4 weeks
5. History of intolerance or hypersensitivity to hypertonic saline or short acting inhaled beta agonist
6. Significant broncho reactivity by examination or pulmonary function testing (PFT), that in the opinion of the investigator would increase the risk of HS use
7. Radiation exposure within the 12 months prior to study participation that would cause them to exceed Federal Regulations by participating in this study
8. Subjects with a positive pregnancy test
9. Subjects who, in the opinion of the Principal Investigator, should not participate in the study
Subjects may be temporarily excluded from screening should they experience a respiratory tract infection that requires treatment with antibiotics and/or steroids. They may become eligible for screening four weeks after completing their treatment providing their symptoms have resolved.
