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OpenTrials
Completed

NCT Number: NCT03078088

Airway Alkalinization and Nasal Colonization

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

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Key information

Conditions

Healthy Subjects Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Univeristy of IOwa

Iowa City, Iowa, 52241, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tham

Drug

alkalinizer

Saline

Drug

Placebo

Primary outcomes

  1. Nasal bacterial colonization

    Time frame: Day 5 of placebo or Tham intervention

    Culture

Secondary outcomes

  1. Safety assessment questionnaire

    Time frame: Day 5 of placebo or Tham intervention

    Questionnaire for local side effects

Sponsors and collaborators

Lead sponsor

Lakshmi Durairaj

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 13, 2017
Registry last updated
Mar 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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