Airway Alkalinization and Nasal Colonization

Cystic Fibrosis Clinical Trial

Official title:

Airway Alkalinization and Nasal Colonization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03078088
• Other study ID #: 201608805
• Status: Completed
• Phase: Phase 1
• Start date: June 15, 2017
• Est. completion date: February 27, 2019

Study information

• Verified date: March 2020
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 27, 2019
• Est. primary completion date: February 27, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Healthy Subjects

Intervention

Drug:
• Tham
alkalinizer
• Saline
Placebo

Locations

Country	Name	City	State
United States	Univeristy of IOwa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Lakshmi Durairaj

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nasal bacterial colonization	Culture	Day 5 of placebo or Tham intervention
Secondary	Safety assessment questionnaire	Questionnaire for local side effects	Day 5 of placebo or Tham intervention