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

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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

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.

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.
We found this trial at
1
site
Iowa City, Iowa 52242
Phone: 319-353-6968
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from
Iowa City, IA
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