Trial Outcomes & Findings for Self-dispersing Liquids as Aerosol Drug Carriers (NCT NCT00628134)

Results Overview

Measured change in central/peripheral (c/p) dose ratio over a 30 minute period after aersol delivery (c/p at t=30 - c/p at t=0). Central and peripheral lung doses are measured as radioactive counts depicted on nuclear medicine gamma camera images after radioisotope aerosol delivery. The central lung zone is a rectangle with 1/2 the height and 1/2 the width of a box outlining the whole right lung. The peripheral lung zone is defined as the portion of the lung outside of the central lung zone. A change in c/p ratio over time would indicate transport of material from one lung zone to the other. The variable represents the realtive proportion of airways dosing to alveolar dosing - an indication of deposition uniformity in the lungs.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

30 minutes

Results posted on

2017-08-24

Participant Flow

Eight subjects with cystic fibrosis were recruited.

Subjects performed two imaging study days. On one study day subjects inhaled Tc-SC particles suspended in calfactant. On the other study day they inhaled the same particles in saline. The order of the study days was randomized.

Participant milestones

Participant milestones
Measure	Surfactant Aerosol Then Saline Aerosol cystic fibrosis patients who inhaled surfactant aerosol at the first study visit and saline aerosol at the second study visit	Saline Aerosol Then Surfactant Aerosol cystic fibrosis patients who inhaled saline aerosol at the first study visit and surfactant aerosol at the second study visit
Overall Study STARTED	4	4
Overall Study COMPLETED	4	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Self-dispersing Liquids as Aerosol Drug Carriers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cystic Fibrosis Subjects n=8 Participants Subjects with cystic fibrosis isotonic saline aerosol : single inhaled dose, 3ml by nebulizer calfactant aerosol : single inhaled dose, 3ml by nebulizer
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	28 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 minutes

Measured change in central/peripheral (c/p) dose ratio over a 30 minute period after aersol delivery (c/p at t=30 - c/p at t=0). Central and peripheral lung doses are measured as radioactive counts depicted on nuclear medicine gamma camera images after radioisotope aerosol delivery. The central lung zone is a rectangle with 1/2 the height and 1/2 the width of a box outlining the whole right lung. The peripheral lung zone is defined as the portion of the lung outside of the central lung zone. A change in c/p ratio over time would indicate transport of material from one lung zone to the other. The variable represents the realtive proportion of airways dosing to alveolar dosing - an indication of deposition uniformity in the lungs.

Outcome measures

Outcome measures
Measure	Subjects Inhaling Saline n=8 Participants Subjects with cystic fibrosis	Subjects Inhaling Surfactant n=8 Participants Subjects with cystic fibrosis
Uniformity of Aerosol Distribution	-0.05 ratio Standard Deviation 0.16	0.10 ratio Standard Deviation 0.10

SECONDARY outcome

Timeframe: 30 minutes after delivery

Change over 30 minutes in the percentage of the total deposited aerosol dose found in the peripheral lung zone. We are reporting the %peripheral dose at t=30 minus the %peripheral dose at t=0. This dose is determined based on measured radioactive counts after aerosol delivery, using nuclear medicine gamma camera images. The central lung zone is defined as a rectangle with 1/2 the height and 1/2 the width of a rectangle that surrounds the right whole lung. The peripheral zone is the portion of the lung image not included in the central lung zone.

Outcome measures

Outcome measures
Measure	Subjects Inhaling Saline n=8 Participants Subjects with cystic fibrosis	Subjects Inhaling Surfactant n=8 Participants Subjects with cystic fibrosis
Peripheral Lung Dose	-3 percentage of lung dose Standard Deviation 5	-8 percentage of lung dose Standard Deviation 8

Adverse Events

Subjects Inhaling Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Subjects Inhaling Surfactant

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, Ph.D.

University of Pittsburgh

Phone: 412-624-8918

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place