Trial Outcomes & Findings for Effect of Lucinactant on Mucus Clearance in Cystic Fibrosis Lung Disease (NCT NCT00934362)
NCT ID: NCT00934362
Last Updated: 2017-03-13
Results Overview
Clearance of radiolabeled particles, following inhalation, are followed over time. Average clearance rate through 60 minutes post inhaled isotope deposition is calculated. Absolute difference between baseline and post-treatment (e.g. \<60 minutes after the last dose of lucinactant or placebo) reported.
COMPLETED
PHASE2
16 participants
1 hour after final treatment (5th dose) minus baseline
2017-03-13
Participant Flow
two week washout period between treatment phases of this cross-over study
Participant milestones
| Measure |
Lucinactant First, Then Placebo
20 mg/ml x 6 ml (5 doses) lucinactant then 0.9% NaCl x 6 ml (5 doses)
|
Placebo First, Then Lucinactant
0.9% NaCl x 6 ml (5 doses) then 20 mg/ml x 6 ml lucinactant (5 doses)
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Lucinactant First, Then Placebo
20 mg/ml x 6 ml (5 doses) lucinactant then 0.9% NaCl x 6 ml (5 doses)
|
Placebo First, Then Lucinactant
0.9% NaCl x 6 ml (5 doses) then 20 mg/ml x 6 ml lucinactant (5 doses)
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Effect of Lucinactant on Mucus Clearance in Cystic Fibrosis Lung Disease
Baseline characteristics by cohort
| Measure |
Lucinactant First, Then Placebo
n=8 Participants
20 mg/ml x 6 ml (5 doses) lucinactant then 0.9% NaCl x 6 ml (5 doses)
|
Placebo First, Then Lucinactant
n=8 Participants
0.9% NaCl x 6 ml (5 doses) then 20 mg/ml x 6 ml lucinactant (5 doses)
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
28.3 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
25.9 years
STANDARD_DEVIATION 6.4 • n=7 Participants
|
27.1 years
STANDARD_DEVIATION 7.5 • 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
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Baseline Mucociliary Clearance Rate
|
9.2 Percentage Clearance
STANDARD_DEVIATION 4.8 • n=5 Participants
|
12.0 Percentage Clearance
STANDARD_DEVIATION 10.5 • n=7 Participants
|
10.5 Percentage Clearance
STANDARD_DEVIATION 8.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: 1 hour after final treatment (5th dose) minus baselinePopulation: Per protocol
Clearance of radiolabeled particles, following inhalation, are followed over time. Average clearance rate through 60 minutes post inhaled isotope deposition is calculated. Absolute difference between baseline and post-treatment (e.g. \<60 minutes after the last dose of lucinactant or placebo) reported.
Outcome measures
| Measure |
Lucinactant
n=15 Participants
20 mg/ml x 6 ml lucinactant (5 doses)
|
Placebo
n=15 Participants
0.9% NaCl x 6 ml (5 doses)
|
|---|---|---|
|
Change in Mucociliary Clearance
|
7.4 percent clearance
Standard Deviation 9.3
|
9.5 percent clearance
Standard Deviation 10.0
|
SECONDARY outcome
Timeframe: after 5 dosesPopulation: per protocol
Percent change (relative) in FEV1 between pre-treatment baseline and following 5 doses of study treatment. Post treatment values obtained 3 and approximately 22 hours after 5th dose were averaged to determine the treatment effect.
Outcome measures
| Measure |
Lucinactant
n=15 Participants
20 mg/ml x 6 ml lucinactant (5 doses)
|
Placebo
n=15 Participants
0.9% NaCl x 6 ml (5 doses)
|
|---|---|---|
|
Spirometry
|
.81 percent change
Standard Deviation .9
|
.23 percent change
Standard Deviation 1.1
|
Adverse Events
Lucinactant
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lucinactant
n=16 participants at risk
20 mg/ml x 6 ml (5 doses)
|
Placebo
n=15 participants at risk
0.9% NaCl x 6 ml (5 doses)
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
cough
|
18.8%
3/16 • Number of events 3
|
13.3%
2/15 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
sinonasal congestion
|
12.5%
2/16 • Number of events 3
|
0.00%
0/15
|
|
Nervous system disorders
headache
|
6.2%
1/16 • Number of events 1
|
13.3%
2/15 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
hemoptysis
|
0.00%
0/16
|
13.3%
2/15 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
6.2%
1/16 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
|
General disorders
fatigue
|
0.00%
0/16
|
6.7%
1/15 • Number of events 1
|
|
Investigations
Decreased lung function
|
6.2%
1/16 • Number of events 1
|
0.00%
0/15
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cystic Fibrosis exacerbation
|
0.00%
0/16
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
6.2%
1/16 • Number of events 1
|
0.00%
0/15
|
Additional Information
Dr. Scott Donaldson
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60