Trial Outcomes & Findings for Analysis of Aldehyde Biomarkers of Exposure and Host Response (NCT NCT00482690)
NCT ID: NCT00482690
Last Updated: 2023-09-07
Results Overview
Aledhydes were assessed in exhaled breath condensate by mass spec and chemical assay.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
Study was terminated at an interim analysis for futility
Results posted on
2023-09-07
Participant Flow
Participant milestones
| Measure |
Nicotine Replacement Therapy Open Label
open label NRT self comparator design
nicotine polacrilex
nicotine transdermal system
nicotine inhaler
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Analysis of Aldehyde Biomarkers of Exposure and Host Response
Baseline characteristics by cohort
| Measure |
Nicotine Replacement Therapy
n=35 Participants
open label NRT self comparator design
nicotine polacrilex
nicotine transdermal system
nicotine inhaler
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Study was terminated at an interim analysis for futilityPopulation: no data were analyzed as specimen collection was inadequate for analysis
Aledhydes were assessed in exhaled breath condensate by mass spec and chemical assay.
Outcome measures
Outcome data not reported
Adverse Events
Nicotine Replacement Therapy Open Label
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