Nasal Potential Studies Utilizing Cystic Fibrosis Transmembrane Regulator (CFTR) Modulators

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01348204
• Date of registration: 01/06/2010
• Prospective Registration: No
• Primary sponsor: University of Alabama at Birmingham
• Public title: Nasal Potential Studies Utilizing Cystic Fibrosis Transmembrane Regulator (CFTR) Modulators
• Scientific title: Nasal Potential Studies Utilizing CFTR Modulators (UAB Center for Clinical and Translational Science)
• Date of first enrolment: March 2010
• Target sample size: 32
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01348204
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Steven M Rowe, MD
• Affiliation: University of Alabama at Birmingham

Key inclusion & exclusion criteria

Inclusion Criteria:

- 8-65 years old

- absence of pulmonary exacerbation in the last 2 weeks

- willingness to perform nasal potential difference measurement

Exclusion Criteria:

- Need for chronic oxygen supplementation

- positive for B. cepecia within the last year

- active participation in another interventional trial utilizing ion transport
modulators

- interfering medical conditions

- pregnant females



Age minimum: 8 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Other: quercetin

Primary Outcome(s)

NPD Biomarker [Time Frame: patients enroll for a single 2-4 hour visit]

Secondary Outcome(s)

Residual CFTR activity [Time Frame: patients enroll for a single 2-4 hour visit]

Secondary ID(s)

F100107002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institutes of Health (NIH)