Cystic Fibrosis, Healthy Subjects
Conditions
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.
Interventions
DRUGTham
alkalinizer
DRUGSaline
Placebo
Sponsors
Lakshmi Durairaj
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nasal bacterial colonization | Day 5 of placebo or Tham intervention | Culture |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety assessment questionnaire | Day 5 of placebo or Tham intervention | Questionnaire for local side effects |
Countries
United States
Outcome results
None listed