Airway Alkalinization and Nasal Colonization
- Registration Number
- NCT03078088
- Lead Sponsor
- Lakshmi Durairaj
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description saline Saline normal saline treatment Tham tham
- Primary Outcome Measures
Name Time Method Nasal bacterial colonization Day 5 of placebo or Tham intervention Culture
- Secondary Outcome Measures
Name Time Method Safety assessment questionnaire Day 5 of placebo or Tham intervention Questionnaire for local side effects
Trial Locations
- Locations (1)
Univeristy of IOwa
🇺🇸Iowa City, Iowa, United States