Trial Outcomes & Findings for Durability of Hypertonic Saline for Enhancing Mucociliary Clearance in Cystic Fibrosis (NCT NCT01094704)
NCT ID: NCT01094704
Last Updated: 2012-08-21
Results Overview
Duration of action of hypertonic saline as determined by measurements of mucociliary clearance/cough clearance 4 hours post dose.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
1-4 hours post-dose
Results posted on
2012-08-21
Participant Flow
Participant milestones
| Measure |
Hypertonic Saline - 1 Hour
Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment one hour post-dose.
|
Hypertonic Saline - 4 Hours
Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment four hours post-dose.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Durability of Hypertonic Saline for Enhancing Mucociliary Clearance in Cystic Fibrosis
Baseline characteristics by cohort
| Measure |
Hypertonic Saline - 1 Hour
n=8 Participants
Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment one hour post-dose.
|
Hypertonic Saline - 4 Hours
n=8 Participants
Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment four hours post-dose.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1-4 hours post-dosePopulation: ITT
Duration of action of hypertonic saline as determined by measurements of mucociliary clearance/cough clearance 4 hours post dose.
Outcome measures
| Measure |
Hypertonic Saline - 1 Hour
n=8 Participants
Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment one hour post-dose.
|
Hypertonic Saline - 4 Hours
n=8 Participants
Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment four hours post-dose.
|
|---|---|---|
|
Change in Average Mucociliary Clearance (0-90 Minutes) at 1 and 4 Hrs Post Dose (MCC4hr - MCCbaseline; MCC1hr - MCCbaseline)
|
5.9 Absolute % change
Standard Deviation 8.9
|
6.7 Absolute % change
Standard Deviation 14.4
|
Adverse Events
Hypertonic Saline - 1 Hour
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hypertonic Saline - 4 Hours
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60