Airway Alkalinization and Nasal Colonization

Lakshmi Durairaj

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects; Cystic Fibrosis

Treatments: Drug: Tham; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03078088

201608805

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Exclusion Criteria:

• Same as for healthy subjects.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 2 patient groups, including a placebo group

saline

Placebo Comparator group

Description:

normal saline

Treatment:

Drug: Saline

treatment

Experimental group

Description:

tham

Treatment:

Drug: Tham