Back to resultsAirway Alkalinization and Nasal Colonization
Primary Purpose
Healthy Subjects, Cystic Fibrosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tham
Saline
Sponsored by
About this trial
This is an interventional prevention trial for Healthy Subjects
Eligibility 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.
Sites / Locations
- Univeristy of IOwa
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
saline
treatment
Arm Description
normal saline
tham
Outcomes
Primary Outcome Measures
Nasal bacterial colonization
Culture
Secondary Outcome Measures
Safety assessment questionnaire
Questionnaire for local side effects
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03078088
Brief Title
Airway Alkalinization and Nasal Colonization
Official Title
Airway Alkalinization and Nasal Colonization
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 15, 2017 (Actual)
Primary Completion Date
February 27, 2019 (Actual)
Study Completion Date
February 27, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lakshmi Durairaj
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Subjects, Cystic Fibrosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
saline
Arm Type
Placebo Comparator
Arm Description
normal saline
Arm Title
treatment
Arm Type
Experimental
Arm Description
tham
Intervention Type
Drug
Intervention Name(s)
Tham
Intervention Description
alkalinizer
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Nasal bacterial colonization
Description
Culture
Time Frame
Day 5 of placebo or Tham intervention
Secondary Outcome Measure Information:
Title
Safety assessment questionnaire
Description
Questionnaire for local side effects
Time Frame
Day 5 of placebo or Tham intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Univeristy of IOwa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52241
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Airway Alkalinization and Nasal Colonization
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