Absorptive Clearance in the Cystic Fibrosis Airway

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-04-30

Brief Summary

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The objective of this overall project is to develop a new aerosol-based technique for quantifying liquid absorption in the airways of subjects with cystic fibrosis(CF) that can be used to help develop new therapies. In CF, mutations in the CF gene result in dysfunction of the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) ion channel on the cells that line the airway epithelium, causing improper fluxes of ions such as sodium, chloride, and bicarbonate. The so called "low volume" hypothesis of CF pathogenesis contends that abnormal absorption of ions from the airways causes excessive absorption of liquid, resulting in an airway surface liquid layer that is dehydrated and difficult to clear. Here we are measuring the absorption rate of a radiolabeled small molecule (DTPA) from the lungs of cystic fibrosis patients and healthy controls. We hypothesize that the molecule will absorb more quickly in cystic fibrosis patients. Further studies will be performed to determine if DTPA absorption is related to liquid absorption in the airways.

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Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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cystic fibrosis

Cystic fibrosis patients

Group Type EXPERIMENTAL

Technetium [Tc-99m] sulfur colloid and Indium [In-111] DTPA

Intervention Type OTHER

Subjects perform a single nuclear medicine scan after inhaling an aerosol containing Technetium 99m sulfur colloid and Indium 111 DTPA.

healthy controls

Healthy control subjects

Group Type EXPERIMENTAL

Technetium [Tc-99m] sulfur colloid and Indium [In-111] DTPA

Intervention Type OTHER

Subjects perform a single nuclear medicine scan after inhaling an aerosol containing Technetium 99m sulfur colloid and Indium 111 DTPA.

Interventions

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Technetium [Tc-99m] sulfur colloid and Indium [In-111] DTPA

Subjects perform a single nuclear medicine scan after inhaling an aerosol containing Technetium 99m sulfur colloid and Indium 111 DTPA.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Cystic fibrosis subjects and healthy controls
* Age ≥ 18 years
* Diagnosis of cystic fibrosis as determined by sweat test or genotype and clinical symptoms (CF subjects)
* Clinically stable as determined by the investigator (pulmonologist)

Exclusion Criteria

* Reactive airways disease
* Tobacco smokers (regular smoking within 6 months of enrollment)
* Positive urine pregnancy test on the day of testing
* FEV1p value of \< 50%
* SaO2 \< 92%, or if they require supplemental oxygen.
* Subjects performing other radioisotope studies within the last 2 weeks will be excluded.
* Healthy subjects with any history of lung disease will be excluded.
* Women currently breastfeeding
* Subjects not willing to stop treatments with inhaled hypertonic saline for 48 hours in advance of the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes