NCT03078088

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 13, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

June 15, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2019

Completed
Last Updated

March 30, 2020

Status Verified

March 1, 2020

Enrollment Period

1.7 years

First QC Date

March 1, 2017

Last Update Submit

March 26, 2020

Conditions

Healthy SubjectsCystic Fibrosis

Outcome Measures

Primary Outcomes (1)

  • Nasal bacterial colonization

    Culture

    Day 5 of placebo or Tham intervention

Secondary Outcomes (1)

  • Safety assessment questionnaire

    Day 5 of placebo or Tham intervention

Study Arms (2)

saline

PLACEBO COMPARATOR

normal saline

Drug: Saline

treatment

EXPERIMENTAL

tham

Drug: Tham

Interventions

ThamDRUG

alkalinizer

treatment
SalineDRUG

Placebo

saline

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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:
  • 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.
  • Same as for healthy subjects.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univeristy of IOwa

Iowa City, Iowa, 52241, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

TromethamineSodium Chloride

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Propylene GlycolsGlycolsAlcoholsOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

March 1, 2017

First Posted

March 13, 2017

Study Start

June 15, 2017

Primary Completion

February 27, 2019

Study Completion

February 27, 2019

Last Updated

March 30, 2020

Record last verified: 2020-03

Locations

US(1)