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Trial Outcomes & Findings for Absorptive Clearance After Inhaled Osmotics in Cystic Fibrosis (NCT NCT01223183)

NCT ID: NCT01223183

Last Updated: 2018-11-29

Results Overview

The clearance rate of Tc-SC after the inhalation of isotonic saline

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

20 participants

Primary outcome timeframe

80 minutes after radiopharmaceutical inhalation

Results posted on

2018-11-29

Participant Flow

Participant milestones

Participant milestones
Measure
Isotonic Saline Then Hypertonic Saline
Subjects inhale nebulized isotonic saline on study day 1, then perform a washout period of 5-24 days, then inhale 7% hypertonic saline on study day 2.
Hypertonic Saline Then Isotonic Saline
Subjects inhale nebulized 7% hypertonic saline on study day 1, then perform a 5-24 day washout period, and then inhale nebulized isotonic saline on study day 2.
Imaging Day 1
STARTED
10
10
Imaging Day 1
COMPLETED
10
9
Imaging Day 1
NOT COMPLETED
0
1
Washout Period (5-24 Days)
STARTED
10
9
Washout Period (5-24 Days)
COMPLETED
8
9
Washout Period (5-24 Days)
NOT COMPLETED
2
0
Imaging Day 2
STARTED
8
9
Imaging Day 2
COMPLETED
8
9
Imaging Day 2
NOT COMPLETED
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Isotonic Saline Then Hypertonic Saline
Subjects inhale nebulized isotonic saline on study day 1, then perform a washout period of 5-24 days, then inhale 7% hypertonic saline on study day 2.
Hypertonic Saline Then Isotonic Saline
Subjects inhale nebulized 7% hypertonic saline on study day 1, then perform a 5-24 day washout period, and then inhale nebulized isotonic saline on study day 2.
Imaging Day 1
Physician Decision
0
1
Washout Period (5-24 Days)
Lost to Follow-up
1
0
Washout Period (5-24 Days)
Physician Decision
1
0

Baseline Characteristics

Absorptive Clearance After Inhaled Osmotics in Cystic Fibrosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Isotonic Saline Then Hypertonic Saline
n=10 Participants
Subjects inhaled isotonic saline on study day 1, then had a washout period of 5-24 days, then inhaled 7% hypertonic saline on study day 2
Hypertonic Saline Then Isotonic Saline
n=10 Participants
Subjects inhaled 7% hypertonic saline on study day 1, then had a washout period of 5-24 days, then inhaled isotonic saline on study day 2
Total
n=20 Participants
Total of all reporting groups
Age, Continuous
27 years
STANDARD_DEVIATION 11 • n=5 Participants
24 years
STANDARD_DEVIATION 5 • n=7 Participants
26 years
STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male
Female
4 Participants
n=5 Participants
4 Participants
n=7 Participants
8 Participants
n=5 Participants
Sex: Female, Male
Male
6 Participants
n=5 Participants
6 Participants
n=7 Participants
12 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 80 minutes after radiopharmaceutical inhalation

Population: This group includes data from the isotonic saline inhalation day from both the "isotonic then hypertonic" and the "hypertonic than isotonic" groups who had sufficient imaging data to allow for full analysis.

The absorption rate of Indium 111 diethylenetriaminepentaacetic acid (In-DTPA) in the airways after the inhalation of isotonic saline

Outcome measures

Outcome measures
Measure
Isotonic Saline Inhalation
n=12 Participants
Results from isotonic inhalation day
Absorptive Clearance Rate After Isotonic Saline Inhalation
32.0 percent cleared / 80 minutes
Standard Deviation 13.9

PRIMARY outcome

Timeframe: 80 minutes after radiopharmaceutical inhalation

Population: This group includes data from the hypertonic saline inhalation day from both the "isotonic then hypertonic" and the "hypertonic than isotonic" groups who had sufficient imaging data to allow for full analysis.

The absorption rate of In-DTPA after the inhalation of hypertonic saline

Outcome measures

Outcome measures
Measure
Isotonic Saline Inhalation
n=11 Participants
Results from isotonic inhalation day
Absorptive Clearance Rate After Hypertonic Saline Inhalation
22.2 percent cleared / 80 minutes
Standard Deviation 12.8

PRIMARY outcome

Timeframe: 80 minutes after radiopharmaceutical inhalation

Population: This group includes data from the isotonic saline inhalation day from both the "isotonic then hypertonic" and the "hypertonic than isotonic" groups who had sufficient imaging data to allow for full analysis.

The clearance rate of Tc-SC after the inhalation of isotonic saline

Outcome measures

Outcome measures
Measure
Isotonic Saline Inhalation
n=12 Participants
Results from isotonic inhalation day
Mucociliary Clearance Rate After Isotonic Saline Inhalation
23.6 percent cleared / 80 minutes
Standard Deviation 10.3

PRIMARY outcome

Timeframe: 80 minutes after radiopharmaceutical inhalation

Population: This group includes data from the hypertonic saline inhalation day from both the "isotonic then hypertonic" and the "hypertonic than isotonic" groups who had sufficient imaging data to allow for full analysis.

The clearance rate of Tc-SC after the inhalation of hypertonic saline

Outcome measures

Outcome measures
Measure
Isotonic Saline Inhalation
n=11 Participants
Results from isotonic inhalation day
Mucociliary Clearance Rate After Hypertonic Saline Inhalation
42.4 percent cleared / 80 minutes
Standard Deviation 18.2

Adverse Events

Isotonic Saline Then Hypertonic Saline

Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths

Hypertonic Saline Then Isotonic Saline

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Isotonic Saline Then Hypertonic Saline
n=10 participants at risk
Subjects inhaled isotonic saline on study day 1 and hypertonic saline on study day 2
Hypertonic Saline Then Isotonic Saline
n=10 participants at risk
Subjects inhaled hypertonic saline on study day 1 and isotonic saline on study day 2
Respiratory, thoracic and mediastinal disorders
hospitalization
10.0%
1/10 • Number of events 1 • From the start of imaging day 1 to the end of imaging day 2
0.00%
0/10 • From the start of imaging day 1 to the end of imaging day 2

Other adverse events

Other adverse events
Measure
Isotonic Saline Then Hypertonic Saline
n=10 participants at risk
Subjects inhaled isotonic saline on study day 1 and hypertonic saline on study day 2
Hypertonic Saline Then Isotonic Saline
n=10 participants at risk
Subjects inhaled hypertonic saline on study day 1 and isotonic saline on study day 2
Respiratory, thoracic and mediastinal disorders
hospitalization
0.00%
0/10 • From the start of imaging day 1 to the end of imaging day 2
0.00%
0/10 • From the start of imaging day 1 to the end of imaging day 2

Additional Information

Tim Corcoran

University of Pittsburgh

Phone: 412-624-8918

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place