Trial Outcomes & Findings for Effects of Symbicort on the Ventilatory Kinematics (NCT NCT01712854)
NCT ID: NCT01712854
Last Updated: 2016-09-02
Results Overview
Our objective is to measure baseline, post treatment and post exercise spirometry and evaluate exercise dynamic hyperinflation before and after treatment using OEP. We hypothesize that budesonide/formoterol fumarate dihydrate will decrease dynamic hyperinflation as measured by OEP.
TERMINATED
PHASE4
9 participants
2 hours
2016-09-02
Participant Flow
The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in February 2013.
Participant milestones
| Measure |
Active Medication or Placebo
Data per arm is not available. Columbia will never have access to this data.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Active Medication or Placebo
Data per arm is not available. Columbia will never have access to this data.
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Effects of Symbicort on the Ventilatory Kinematics
Baseline characteristics by cohort
| Measure |
Active Medication or Placebo
n=9 Participants
Data per arm is not available. Columbia will never have access to this data.
|
|---|---|
|
Age, Customized
Between 40 and 75 years
|
9 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male and Female
|
9 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 hoursPopulation: The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in February 2013.
Our objective is to measure baseline, post treatment and post exercise spirometry and evaluate exercise dynamic hyperinflation before and after treatment using OEP. We hypothesize that budesonide/formoterol fumarate dihydrate will decrease dynamic hyperinflation as measured by OEP.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 hoursPopulation: The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in February 2013.
Our secondary objective is to evaluate duration of steady state exercise and exercise capacity before and after treatment. Our secondary hypothesis is that decreases in dynamic hyperinflation during exercise will lead to improvements in dyspnea with exercise, and allow for increases in exercise capacity.
Outcome measures
Outcome data not reported
Adverse Events
Active Medication or Placebo
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