Trial Outcomes & Findings for Using Rheological Methods to Characterize Cystic Fibrosis (CF) Sputum and the Effects of Mucoactive Agents (NCT NCT00758771)
NCT ID: NCT00758771
Last Updated: 2014-03-05
Results Overview
Baseline measure of sputum shear rheology
Recruitment status
COMPLETED
Target enrollment
38 participants
Primary outcome timeframe
Cross-sectional
Results posted on
2014-03-05
Participant Flow
Participant milestones
| Measure |
Cystic Fibrosis
Individuals who have been diagnosed with cystic fibrosis.
|
Healthy
Individuals who do not have cystic fibrosis and who do not have any other lung conditions
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
20
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
Cystic Fibrosis
Individuals who have been diagnosed with cystic fibrosis.
|
Healthy
Individuals who do not have cystic fibrosis and who do not have any other lung conditions
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Did not meet eligibility criteria
|
2
|
4
|
Baseline Characteristics
Using Rheological Methods to Characterize Cystic Fibrosis (CF) Sputum and the Effects of Mucoactive Agents
Baseline characteristics by cohort
| Measure |
Cystic Fibrosis
n=15 Participants
Individuals who have been diagnosed with cystic fibrosis.
|
Healthy
n=15 Participants
Individuals who do not have cystic fibrosis and who do not have any other lung conditions
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.6 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
41.9 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
38.8 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Cross-sectionalBaseline measure of sputum shear rheology
Outcome measures
| Measure |
Cystic Fibrosis
n=15 Participants
Individuals who have been diagnosed with cystic fibrosis.
|
Healthy
n=15 Participants
Individuals who do not have cystic fibrosis and who do not have any other lung conditions
|
|---|---|---|
|
Shear Rheology
|
6.0 Pascal
Standard Error 2.0
|
1.8 Pascal
Standard Error 0.2
|
Adverse Events
Cystic Fibrosis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy
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