Airway Alkalinization and Nasal Colonization

Lakshmi Durairaj32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Healthy Subjects Cystic Fibrosis

Interventions

ThamDRUG

alkalinizer

SalineDRUG

Placebo

Eligibility

Sex: ALLMin age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Univeristy of IOwa

Iowa City, Iowa, United States

Outcomes

Primary Outcomes

Nasal bacterial colonization

Culture

Time frame: Day 5 of placebo or Tham intervention

Secondary Outcomes

Safety assessment questionnaire

Questionnaire for local side effects

Time frame: Day 5 of placebo or Tham intervention

Data from ClinicalTrials.gov

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