Trial Outcomes & Findings for Imaging Airway Liquid Absorption in Cystic Fibrosis (NCT NCT01486199)

Results Overview

Absorptive clearance rate measured 80 minutes after radiopharmaceutical inhalation. Absorptive clearance is the absorptive component of the clearance of Indium 111-diethylenetriaminepentaacetic acid (In-DTPA) from the lungs.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

study day 1

Results posted on

2017-09-25

Participant Flow

Participant milestones

Participant milestones
Measure	CF Pediatric Cystic Fibrosis subjects ages 6-14	Controls Adult Adult control subjects 18 or older
Baseline Study Day STARTED	10	10
Baseline Study Day COMPLETED	10	9
Baseline Study Day NOT COMPLETED	0	1
Two Year Period Between Study Days STARTED	10	0
Two Year Period Between Study Days COMPLETED	9	0
Two Year Period Between Study Days NOT COMPLETED	1	0
Study Day at t= 2 Years STARTED	9	0
Study Day at t= 2 Years COMPLETED	9	0
Study Day at t= 2 Years NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	CF Pediatric Cystic Fibrosis subjects ages 6-14	Controls Adult Adult control subjects 18 or older
Two Year Period Between Study Days Physician Decision	1	0

Baseline Characteristics

Imaging Airway Liquid Absorption in Cystic Fibrosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CF Pediatric n=10 Participants Cystic Fibrosis subjects ages 6-14	Controls Adult n=10 Participants Adult control subjects 18 or older	Total n=20 Participants Total of all reporting groups
Age, Continuous	10.5 years STANDARD_DEVIATION 1.5 • n=93 Participants	31.2 years STANDARD_DEVIATION 15.0 • n=4 Participants	20.9 years STANDARD_DEVIATION 14.9 • n=27 Participants
Sex: Female, Male Female	5 Participants n=93 Participants	4 Participants n=4 Participants	9 Participants n=27 Participants
Sex: Female, Male Male	5 Participants n=93 Participants	6 Participants n=4 Participants	11 Participants n=27 Participants

PRIMARY outcome

Timeframe: study day 1

Population: One pediatric subject did not deposit sufficient aerosol to be analyzed. One control subject did not perform imaging procedures after signing consent because of a low result on a screening pulmonary function testing.

Absorptive clearance rate measured 80 minutes after radiopharmaceutical inhalation. Absorptive clearance is the absorptive component of the clearance of Indium 111-diethylenetriaminepentaacetic acid (In-DTPA) from the lungs.

Outcome measures

Outcome measures
Measure	CF Pediatric n=9 Participants CF subjects ages 6-14	Controls Adult n=9 Participants Adult control subjects 18 or older
Absorptive Clearance Rate	34.0 percent cleared / 80 minutes Standard Deviation 10.4	17.7 percent cleared / 80 minutes Standard Deviation 6.9

PRIMARY outcome

Timeframe: study day 1

Population: One pediatric subject did not deposit sufficient aerosol to be analyzed. One control subject did not perform imaging procedures after signing consent because of a low result on a screening pulmonary function testing.

Mucociliary clearance rate measured 80 minutes after radiopharmaceutical inhalation. Mucociliary clearance rate is the rate of clearance of Technetium sulfur colloid (Tc-SC) from the lungs.

Outcome measures

Outcome measures
Measure	CF Pediatric n=9 Participants CF subjects ages 6-14	Controls Adult n=9 Participants Adult control subjects 18 or older
Mucociliary Clearance Rate	22.8 percent cleared / 80 minutes Standard Deviation 13.7	31.4 percent cleared / 80 minutes Standard Deviation 13.1

SECONDARY outcome

Timeframe: t=2 years

Population: Only pediatric CF subjects performed 2 year follow-up scan. One subject did not perform the second imaging day since day one image quality was poor. Two other subjects had poor imaging data on follow up day and were therefore not included in analysis.

Absorptive Clearance Rate measured 80 minutes after radiopharmaceutical inhalation. Absorptive clearance is the absorptive component of the clearance of In-DTPA from the lungs.

Outcome measures

Outcome measures
Measure	CF Pediatric n=7 Participants CF subjects ages 6-14	Controls Adult Adult control subjects 18 or older
Absorptive Clearance Rate	28.6 percent cleared / 80 min Standard Deviation 9.9	—

SECONDARY outcome

Timeframe: t=2 years, measure made 80 minutes after radiopharmaceutical inhalation

Population: Only pediatric CF subjects performed 2 year follow-up scan. One subject did not perform the second imaging day since day one image quality was poor. Two other subjects had poor imaging data on follow up day and were therefore not included in analysis.

Mucociliary clearance rate measured 80 minutes after radiopharmaceutical inhalation. Mucociliary clearance rate is the rate of clearance of Technetium sulfur colloid (Tc-SC) from the lungs.

Outcome measures

Outcome measures
Measure	CF Pediatric n=7 Participants CF subjects ages 6-14	Controls Adult Adult control subjects 18 or older
Mucociliary Clearance Rate	22.0 percent cleared / 80 minutes Standard Deviation 13.1	—

Adverse Events

CF Pediatric

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Controls Adult

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