Airway Alkalinization and Nasal Colonization
Status: | Recruiting |
---|---|
Conditions: | Healthy Studies, Pulmonary |
Therapuetic Areas: | Pulmonary / Respiratory Diseases, Other |
Healthy: | No |
Age Range: | 16 - Any |
Updated: | 8/22/2018 |
Start Date: | June 15, 2017 |
End Date: | December 2020 |
Contact: | Jan Launspach, RN |
Email: | janice-launspach@uiowa.edu |
Phone: | 319-356-2047 |
The study will be a randomized, cross-over study of THAM followed by saline or saline
followed by THAM in human non-CF and CF subjects to assess nasal colonization
followed by THAM in human non-CF and CF subjects to assess nasal colonization
16 subjects per group will be randomized to receive study drug or saline followed by a wash
out period and cross-over to the other treatment, three times daily for 4 days. Nasal swab
will be done at baseline and after both study treatment and saline treatment for assessment
of airway colonization.
out period and cross-over to the other treatment, three times daily for 4 days. Nasal swab
will be done at baseline and after both study treatment and saline treatment for assessment
of airway colonization.
Healthy subjects:
Inclusion Criteria:
- 16 subjects, aged 16-80, clinically stable with no significant changes in health
status for 14 days prior to Day 1, written informed consent obtained fom subject.
Exclusion Criteria:
- Pregnant or lactating
- Use of any investigational drug and/or participated in any interventional clinical
trial within 28 days prior to screening, smoked in the last 6 months.
CF subjects:
Inclusion Criteria:
- FEV1% >35%, O2 saturation >90% on room air, clinically stable with no significant
changes in health status for 14 days prior to Day 1, written informed consent obtained
from subject.
Exclusion Criteria:
- Same as for healthy subjects.
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