Airway Alkalinization and Nasal Colonization
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy Subjects, Cystic Fibrosis
In brief
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
Key facts
- Study ID
- NCT03078088
- Run by
- Lakshmi Durairaj
- People needed
- 32
- Starts
- 2017-06-15
- Expected to finish
- 2019-02-27
- Last updated by the study team
- 2020-03-30
Who can join
Age: 16 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Univeristy of IOwa — Iowa City, Iowa, United States
Full record on ClinicalTrials.gov
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