Trial Outcomes & Findings for Absorptive Clearance in the Cystic Fibrosis Airway (NCT NCT00541190)

Results Overview

The absorptive clearance rate is the percentage of the radiolabeled small molecule DTPA that is cleared through absorption over a 60 minute period. Total DTPA clearance includes absorptive and mucociliary components. The mucociliary component is determined by measuring the clearance of a radiolabeled particle over the same period (Technetium 99m sulfur colloid; Tc-SC), and subtracted from total DTPA clearance in order to determine the absorptive component. Here we specifically report absorption from the central lung zone to capture the behavior within the airways.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

single measurement

Results posted on

2017-08-24

Participant Flow

Cystic fibrosis subjects were recruited during normal clinical visits. Healthy control subjects were recruited using posted advertisement.

All enrolled subjects performed a single nuclear medicine imaging study.

Participant milestones

Participant milestones
Measure	Cystic Fibrosis Cystic fibrosis patients	Healthy Controls Healthy subjects.
Overall Study STARTED	10	11
Overall Study COMPLETED	10	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Absorptive Clearance in the Cystic Fibrosis Airway

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cystic Fibrosis n=10 Participants Cystic fibrosis patients	Healthy Controls n=11 Participants Healthy subjects.	Total n=21 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=99 Participants	11 Participants n=107 Participants	21 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	29 years STANDARD_DEVIATION 11 • n=99 Participants	29 years STANDARD_DEVIATION 7 • n=107 Participants	29 years STANDARD_DEVIATION 9 • n=206 Participants
Sex: Female, Male Female	3 Participants n=99 Participants	5 Participants n=107 Participants	8 Participants n=206 Participants
Sex: Female, Male Male	7 Participants n=99 Participants	6 Participants n=107 Participants	13 Participants n=206 Participants
Region of Enrollment United States	10 participants n=99 Participants	11 participants n=107 Participants	21 participants n=206 Participants

PRIMARY outcome

Timeframe: single measurement

Population: No formal power analysis was performed for this pilot study. Two subjects (one CF, one control) were identified as obvious outliers with whole lung Tc-SC clearance rates more than two standard deviations above the average of the group. These outliers were excluded from further analyses.

The absorptive clearance rate is the percentage of the radiolabeled small molecule DTPA that is cleared through absorption over a 60 minute period. Total DTPA clearance includes absorptive and mucociliary components. The mucociliary component is determined by measuring the clearance of a radiolabeled particle over the same period (Technetium 99m sulfur colloid; Tc-SC), and subtracted from total DTPA clearance in order to determine the absorptive component. Here we specifically report absorption from the central lung zone to capture the behavior within the airways.

Outcome measures

Outcome measures
Measure	Cystic Fibrosis n=9 Participants Cystic fibrosis patients - subjects inhaled a nebulized mixture of Indium 111 DTPA and Technetium 99m sulfur colloid.	Healthy Controls n=10 Participants Healthy subjects without lung disease - subjects inhaled a nebulized mixture of Indium 111 DTPA and Technetium 99m sulfur colloid.
Absorptive Clearance Rate	42 percentage of DTPA absoprtion per hour Standard Deviation 11	32 percentage of DTPA absoprtion per hour Standard Deviation 7

SECONDARY outcome

Timeframe: single measurement

Population: No formal power analysis was performed for this pilot study. Two subjects (one CF, one control) were identified as obvious outliers with whole lung Tc-SC clearance rates more than two standard deviations above the average of the group. These outliers were excluded from further analyses.

Mucociliary clearance rate represents the rate at which the lungs clear an inhaled particulate. Here it specifically represents the percentage of inhaled Technetium 99m sulfur colloid cleared from the lungs over a 60 minute period. This is reported based on "whole lung" areas to allow comparisons with previous studies.

Outcome measures

Outcome measures
Measure	Cystic Fibrosis n=9 Participants Cystic fibrosis patients - subjects inhaled a nebulized mixture of Indium 111 DTPA and Technetium 99m sulfur colloid.	Healthy Controls n=10 Participants Healthy subjects without lung disease - subjects inhaled a nebulized mixture of Indium 111 DTPA and Technetium 99m sulfur colloid.
Mucociliary Clearance Rate	8 percentage lung clearance per hour Standard Deviation 4	7 percentage lung clearance per hour Standard Deviation 4

Adverse Events

Cystic Fibrosis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tim Corcoran

University of Pittsburgh

Phone: 412-624-8918

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place