Trial Outcomes & Findings for A Study of Gamma Tocopherol-enriched Supplement on Lower Airway Responses to Inhaled Wood Smoke in Healthy Adults (NCT NCT03444298)
NCT ID: NCT03444298
Last Updated: 2024-02-05
Results Overview
A comparison of the WSP-induced change in sputum % PMNs (Post-WSP sputum - Pre-WSP sputum) during gamma tocopherol treatment with the WSP-induced change in sputum % PMNs during placebo treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
baseline, and 4 hours post exposure
Results posted on
2024-02-05
Participant Flow
Eleven persons completed the study. The original gT dose was 1 dose every 12 hours x 4 (n=4 volunteers), but was ineffective in another study, so dosing was increased to 7 daily doses (n=4 volunteers). The gT expired during an 18 month pause for COVID-19 and could not be replaced, and a similarly potent commercially available gT-enriched preparation for 7 daily doses was then used for the final 3 persons. An intent-to-treat analysis of primary end points for all completed volunteers was used.
Participant milestones
| Measure |
Placebo First, Then Gamma Tocopherol
Participants that are randomized to placebo treatment will take a short treatment course of Neutral Oil followed by chamber exposure with wood smoke particulate. After a 4-week washout period, participants will cross over to the gamma Tocopherol (active) treatment group.
Gamma Tocopherol (gT): Each dose consists of two (700 mg) capsules by mouth once daily for a total of 7 days.
Placebo: Each dose consists of two capsules by mouth once daily for a total of 7 days.
|
GammaTocopherol First, Then Placebo
Participants that are randomized γT treatment will take a short treatment course of gamma Tocopherol followed by chamber exposure with WSP. After a 4-week washout period, participants will cross over to the placebo treatment group.
Gamma Tocopherol: Each dose consists of two (700 mg) capsules by mouth once daily for a total of 7 days.
Placebo: Each dose consists of two capsules by mouth once daily for a total of 7 days.
|
|---|---|---|
|
Period 1 (Dosing Followed by Exposure)
STARTED
|
7
|
9
|
|
Period 1 (Dosing Followed by Exposure)
COMPLETED
|
7
|
9
|
|
Period 1 (Dosing Followed by Exposure)
NOT COMPLETED
|
0
|
0
|
|
Washout (>/= 4 Weeks)
STARTED
|
7
|
9
|
|
Washout (>/= 4 Weeks)
COMPLETED
|
4
|
7
|
|
Washout (>/= 4 Weeks)
NOT COMPLETED
|
3
|
2
|
|
Period 2 (Dosing Followed by Exposure)
STARTED
|
4
|
7
|
|
Period 2 (Dosing Followed by Exposure)
COMPLETED
|
4
|
7
|
|
Period 2 (Dosing Followed by Exposure)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Gamma Tocopherol-enriched Supplement on Lower Airway Responses to Inhaled Wood Smoke in Healthy Adults
Baseline characteristics by cohort
| Measure |
Placebo First, Then Gamma Tocopherol
n=7 Participants
Participants that are randomized to placebo treatment will take a short treatment course of Neutral Oil followed by chamber exposure with wood smoke particulate. After a 4-week washout period, participants will cross over to the gamma Tocopherol (active) treatment group.
Gamma Tocopherol: Each dose consists of two (700 mg) capsules by mouth once daily for a total of 7 days.
Placebo: Each dose consists of two capsules by mouth once daily for a total of 7 days.
|
GammaTocopherol First, Then Placebo
n=9 Participants
Participants that are randomized γT treatment will take a short treatment course of gamma Tocopherol followed by chamber exposure with WSP. After a 4-week washout period, participants will cross over to the placebo treatment group.
Gamma Tocopherol: Each dose consists of two (700 mg) capsules by mouth once daily for a total of 7 days.
Placebo: Each dose consists of two capsules by mouth once daily for a total of 7 days.
|
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
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
00 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, and 4 hours post exposurePopulation: Data are reported for participants who completed both arms and provided adequate sputum samples.
A comparison of the WSP-induced change in sputum % PMNs (Post-WSP sputum - Pre-WSP sputum) during gamma tocopherol treatment with the WSP-induced change in sputum % PMNs during placebo treatment.
Outcome measures
| Measure |
GammaTocopherol
n=11 Participants
Participants receive two (700 mg) capsules by mouth once daily for a total of 7 days.
|
Placebo
n=11 Participants
Participants receive two placebo capsules by mouth once daily for a total of 7 days.
|
Placebo
Participants receive two placebo capsules by mouth once daily for a total of 7 days.
|
|---|---|---|---|
|
Change in Sputum % Polymorphonuclear Neutrophils (PMN) With Wood Smoke Particulate (WSP) Exposure
|
18.00 percent PMNs
Standard Deviation 20.89
|
14.75 percent PMNs
Standard Deviation 17.98
|
—
|
PRIMARY outcome
Timeframe: baseline, and 24 hours post exposurePopulation: Data are reported for participants who completed both arms and provided adequate sputum samples as outlined for each arm. Three participants did not have adequate sputum at 24 hours after active treatment.
A comparison of the WSP-induced change in sputum % PMNs (Post-WSP sputum - Pre-WSP sputum) during gamma tocopherol treatment with the WSP-induced change in sputum % PMNs during placebo treatment.
Outcome measures
| Measure |
GammaTocopherol
n=8 Participants
Participants receive two (700 mg) capsules by mouth once daily for a total of 7 days.
|
Placebo
n=11 Participants
Participants receive two placebo capsules by mouth once daily for a total of 7 days.
|
Placebo
Participants receive two placebo capsules by mouth once daily for a total of 7 days.
|
|---|---|---|---|
|
Change in Sputum % PMNs With WSP Exposure
|
39.87 percent PMNs
Standard Deviation 20.59
|
29.35 percent PMNs
Standard Deviation 28.30
|
—
|
SECONDARY outcome
Timeframe: baseline, and 4 hours post exposurePopulation: Data are reported for participants who completed both arms and provided adequate sputum samples as outlined for each arm. Three participants did not have adequate sputum at 24 hours after active treatment.
A comparison of the WSP-induced change in sputum ANC (Post-WSP sputum - Pre-WSP sputum) during gamma tocopherol treatment with the WSP-induced change in sputum ANC during placebo treatment.
Outcome measures
| Measure |
GammaTocopherol
n=8 Participants
Participants receive two (700 mg) capsules by mouth once daily for a total of 7 days.
|
Placebo
n=11 Participants
Participants receive two placebo capsules by mouth once daily for a total of 7 days.
|
Placebo
Participants receive two placebo capsules by mouth once daily for a total of 7 days.
|
|---|---|---|---|
|
Change in Absolute PMN Count (ANC) in Sputum With WSP Exposure
|
8.58 PMNs per mg sputum
Standard Deviation 150.6
|
-20.51 PMNs per mg sputum
Standard Deviation 160.6
|
—
|
SECONDARY outcome
Timeframe: baseline, and 24 hours post exposurePopulation: Data are reported for participants who completed both arms and provided adequate sputum samples as outlined for each arm. Three participants did not have adequate sputum at 24 hours after active treatment.
A comparison of the WSP-induced change in sputum ANC (Post-WSP sputum - Pre-WSP sputum) during gamma tocopherol treatment with the WSP-induced change in sputum ANC during placebo treatment.
Outcome measures
| Measure |
GammaTocopherol
n=8 Participants
Participants receive two (700 mg) capsules by mouth once daily for a total of 7 days.
|
Placebo
n=11 Participants
Participants receive two placebo capsules by mouth once daily for a total of 7 days.
|
Placebo
Participants receive two placebo capsules by mouth once daily for a total of 7 days.
|
|---|---|---|---|
|
Change in Absolute PMN Count (ANC) in Sputum With WSP Exposure
|
104.7 PMNs per mg sputum
Standard Deviation 146.5
|
96.7 PMNs per mg sputum
Standard Deviation 156.2
|
—
|
POST_HOC outcome
Timeframe: up to 24 hoursPopulation: Data are reported for participants who completed both arms and provided adequate sputum samples.
A comparison of the WSP-induced sputum % eosinophils versus predosing values with gamma tocopherol and placebo treatment.
Outcome measures
| Measure |
GammaTocopherol
n=11 Participants
Participants receive two (700 mg) capsules by mouth once daily for a total of 7 days.
|
Placebo
n=11 Participants
Participants receive two placebo capsules by mouth once daily for a total of 7 days.
|
Placebo
n=11 Participants
Participants receive two placebo capsules by mouth once daily for a total of 7 days.
|
|---|---|---|---|
|
Percent Eosinophils in Sputum
4 Hours
|
0.07 percent eosinophils
Standard Deviation 0.04
|
0.04 percent eosinophils
Standard Deviation 0.08
|
2.3 percent eosinophils
Standard Deviation 1.6
|
|
Percent Eosinophils in Sputum
24 Hours
|
0.07 percent eosinophils
Standard Deviation 0.04
|
0.26 percent eosinophils
Standard Deviation 0.15
|
0.39 percent eosinophils
Standard Deviation 0.33
|
POST_HOC outcome
Timeframe: up to 24 hoursPopulation: Data are reported for participants who completed both arms and provided adequate sputum samples.
A comparison of the WSP-induced sputum eosinophils after gamma tocopherol and placebo pre dosing values.
Outcome measures
| Measure |
GammaTocopherol
n=11 Participants
Participants receive two (700 mg) capsules by mouth once daily for a total of 7 days.
|
Placebo
n=11 Participants
Participants receive two placebo capsules by mouth once daily for a total of 7 days.
|
Placebo
n=11 Participants
Participants receive two placebo capsules by mouth once daily for a total of 7 days.
|
|---|---|---|---|
|
Eosinophils Per mg Sputum
4 Hours
|
0.17 Cells per mg (eosinophils)
Standard Deviation 0.33
|
0.20 Cells per mg (eosinophils)
Standard Deviation 0.52
|
7.10 Cells per mg (eosinophils)
Standard Deviation 12.33
|
|
Eosinophils Per mg Sputum
24 Hours
|
0.17 Cells per mg (eosinophils)
Standard Deviation 0.33
|
1.15 Cells per mg (eosinophils)
Standard Deviation 2.11
|
1.02 Cells per mg (eosinophils)
Standard Deviation 2.70
|
POST_HOC outcome
Timeframe: up to 24 hoursPopulation: Data are reported for participants who completed both arms and provided adequate sputum samples.
The IL-1β concentration will be determined in each sputum sample by immunoassay
Outcome measures
| Measure |
GammaTocopherol
n=11 Participants
Participants receive two (700 mg) capsules by mouth once daily for a total of 7 days.
|
Placebo
n=11 Participants
Participants receive two placebo capsules by mouth once daily for a total of 7 days.
|
Placebo
n=11 Participants
Participants receive two placebo capsules by mouth once daily for a total of 7 days.
|
|---|---|---|---|
|
Interleukin-1 Beta (IL-1β) in Sputum
4 Hours
|
798.3 pg/mL
Standard Deviation 497.1
|
674.2 pg/mL
Standard Deviation 494.9
|
654.4 pg/mL
Standard Deviation 438.3
|
|
Interleukin-1 Beta (IL-1β) in Sputum
24 Hours
|
798.3 pg/mL
Standard Deviation 497.1
|
469.6 pg/mL
Standard Deviation 237.4
|
675.2 pg/mL
Standard Deviation 630.6
|
POST_HOC outcome
Timeframe: up to 24 hoursPopulation: Data are reported for participants who completed both arms and provided adequate sputum samples.
The IL-6 concentration will be determined in each sputum sample by immunoassay
Outcome measures
| Measure |
GammaTocopherol
n=11 Participants
Participants receive two (700 mg) capsules by mouth once daily for a total of 7 days.
|
Placebo
n=11 Participants
Participants receive two placebo capsules by mouth once daily for a total of 7 days.
|
Placebo
n=11 Participants
Participants receive two placebo capsules by mouth once daily for a total of 7 days.
|
|---|---|---|---|
|
Interleukin-6 (IL-6) in Sputum
24 Hours
|
458.0 pg/mL
Standard Deviation 492.3
|
207.0 pg/mL
Standard Deviation 171.6
|
281.3 pg/mL
Standard Deviation 338.0
|
|
Interleukin-6 (IL-6) in Sputum
4 Hours
|
458.0 pg/mL
Standard Deviation 492.3
|
384.8 pg/mL
Standard Deviation 440.2
|
277.5 pg/mL
Standard Deviation 255.5
|
POST_HOC outcome
Timeframe: up to 24 hoursPopulation: Data are reported for participants who completed both arms and provided adequate sputum samples.
The IL-8 concentration will be determined in each sputum sample by immunoassay
Outcome measures
| Measure |
GammaTocopherol
n=11 Participants
Participants receive two (700 mg) capsules by mouth once daily for a total of 7 days.
|
Placebo
n=11 Participants
Participants receive two placebo capsules by mouth once daily for a total of 7 days.
|
Placebo
n=11 Participants
Participants receive two placebo capsules by mouth once daily for a total of 7 days.
|
|---|---|---|---|
|
Interleukin-8 (IL-8) in Sputum
4 Hours
|
30850 pg/mL
Standard Deviation 28306
|
31724 pg/mL
Standard Deviation 37505
|
25432 pg/mL
Standard Deviation 23198
|
|
Interleukin-8 (IL-8) in Sputum
24 Hours
|
30850 pg/mL
Standard Deviation 28306
|
17180 pg/mL
Standard Deviation 13083
|
36739 pg/mL
Standard Deviation 60134
|
POST_HOC outcome
Timeframe: up to 24 hoursPopulation: Data are reported for participants who completed both arms and provided adequate sputum samples.
The TNF-a concentration will be determined in each sputum sample by immunoassay
Outcome measures
| Measure |
GammaTocopherol
n=11 Participants
Participants receive two (700 mg) capsules by mouth once daily for a total of 7 days.
|
Placebo
n=11 Participants
Participants receive two placebo capsules by mouth once daily for a total of 7 days.
|
Placebo
n=11 Participants
Participants receive two placebo capsules by mouth once daily for a total of 7 days.
|
|---|---|---|---|
|
Tumor Necrosis Factor-alpha (TNF-a)
4 Hours
|
35.67 pg/mL
Standard Deviation 25.88
|
127.7 pg/mL
Standard Deviation 342.7
|
25.18 pg/mL
Standard Deviation 20.84
|
|
Tumor Necrosis Factor-alpha (TNF-a)
24 Hours
|
35.67 pg/mL
Standard Deviation 25.88
|
13.77 pg/mL
Standard Deviation 12.63
|
29.23 pg/mL
Standard Deviation 26.18
|
POST_HOC outcome
Timeframe: Baseline immediately before WSP challengePopulation: Data are reported for participants who completed both arms.
The alpha tocopherol concentration will be determined in blood samples by high-performance liquid chromatography (HPLC).
Outcome measures
| Measure |
GammaTocopherol
n=11 Participants
Participants receive two (700 mg) capsules by mouth once daily for a total of 7 days.
|
Placebo
n=11 Participants
Participants receive two placebo capsules by mouth once daily for a total of 7 days.
|
Placebo
Participants receive two placebo capsules by mouth once daily for a total of 7 days.
|
|---|---|---|---|
|
Alpha Tocopherol in Blood
|
22.54 microM
Standard Deviation 10.17
|
24.58 microM
Standard Deviation 3.40
|
—
|
POST_HOC outcome
Timeframe: Baseline immediately before WSP challengePopulation: Data are reported for participants who completed both arms.
The 2, 7,8-trimethyl-2S-(g-carboxyethyl)-6-hydroxychromane (g-CEHC) concentration will be determined in blood samples by high-performance liquid chromatography (HPLC).
Outcome measures
| Measure |
GammaTocopherol
n=11 Participants
Participants receive two (700 mg) capsules by mouth once daily for a total of 7 days.
|
Placebo
n=11 Participants
Participants receive two placebo capsules by mouth once daily for a total of 7 days.
|
Placebo
Participants receive two placebo capsules by mouth once daily for a total of 7 days.
|
|---|---|---|---|
|
2, 7,8-trimethyl-2S-(G-carboxyethyl)-6-hydroxychromane (g-CEHC) in Blood
|
1.912 microM
Standard Deviation 2.021
|
0.084 microM
Standard Deviation 0.08
|
—
|
POST_HOC outcome
Timeframe: Baseline immediately before WSP challengePopulation: Data are reported for participants who completed both arms.
The gamma tocopherol concentration will be determined in blood samples by high-performance liquid chromatography (HPLC).
Outcome measures
| Measure |
GammaTocopherol
n=11 Participants
Participants receive two (700 mg) capsules by mouth once daily for a total of 7 days.
|
Placebo
n=11 Participants
Participants receive two placebo capsules by mouth once daily for a total of 7 days.
|
Placebo
Participants receive two placebo capsules by mouth once daily for a total of 7 days.
|
|---|---|---|---|
|
GammaTocopherol in Blood
|
32.60 microM
Standard Deviation 7.45
|
4.64 microM
Standard Deviation 1.71
|
—
|
Adverse Events
GammaTocopherol
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
GammaTocopherol
n=13 participants at risk
Each dose consists of two (700 mg) capsules by mouth once daily for a total of 7 days.
|
Placebo
n=14 participants at risk
Each dose consists of two placebo capsules by mouth once daily for a total of 7 days.
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal Distress
|
53.8%
7/13 • Number of events 8 • From the time a participant signed consent through completion of the second intervention, a total of up to 5 months.
|
14.3%
2/14 • Number of events 2 • From the time a participant signed consent through completion of the second intervention, a total of up to 5 months.
|
|
General disorders
Headache
|
15.4%
2/13 • Number of events 2 • From the time a participant signed consent through completion of the second intervention, a total of up to 5 months.
|
21.4%
3/14 • Number of events 3 • From the time a participant signed consent through completion of the second intervention, a total of up to 5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Viral Upper Respiratory Infection
|
7.7%
1/13 • Number of events 1 • From the time a participant signed consent through completion of the second intervention, a total of up to 5 months.
|
7.1%
1/14 • Number of events 1 • From the time a participant signed consent through completion of the second intervention, a total of up to 5 months.
|
|
Skin and subcutaneous tissue disorders
Rash on both inner arms
|
0.00%
0/13 • From the time a participant signed consent through completion of the second intervention, a total of up to 5 months.
|
7.1%
1/14 • Number of events 1 • From the time a participant signed consent through completion of the second intervention, a total of up to 5 months.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/13 • From the time a participant signed consent through completion of the second intervention, a total of up to 5 months.
|
7.1%
1/14 • Number of events 1 • From the time a participant signed consent through completion of the second intervention, a total of up to 5 months.
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/13 • From the time a participant signed consent through completion of the second intervention, a total of up to 5 months.
|
7.1%
1/14 • Number of events 1 • From the time a participant signed consent through completion of the second intervention, a total of up to 5 months.
|
|
Eye disorders
Eye Irritation
|
7.7%
1/13 • Number of events 1 • From the time a participant signed consent through completion of the second intervention, a total of up to 5 months.
|
0.00%
0/14 • From the time a participant signed consent through completion of the second intervention, a total of up to 5 months.
|
|
Musculoskeletal and connective tissue disorders
Pinched Nerve in Neck
|
0.00%
0/13 • From the time a participant signed consent through completion of the second intervention, a total of up to 5 months.
|
7.1%
1/14 • Number of events 1 • From the time a participant signed consent through completion of the second intervention, a total of up to 5 months.
|
|
Vascular disorders
Nosebleed
|
7.7%
1/13 • Number of events 1 • From the time a participant signed consent through completion of the second intervention, a total of up to 5 months.
|
0.00%
0/14 • From the time a participant signed consent through completion of the second intervention, a total of up to 5 months.
|
|
General disorders
Unusual Fatigue or Tiredness
|
7.7%
1/13 • Number of events 1 • From the time a participant signed consent through completion of the second intervention, a total of up to 5 months.
|
7.1%
1/14 • Number of events 1 • From the time a participant signed consent through completion of the second intervention, a total of up to 5 months.
|
|
Cardiac disorders
Premature Ventricular Contraction
|
7.7%
1/13 • Number of events 1 • From the time a participant signed consent through completion of the second intervention, a total of up to 5 months.
|
0.00%
0/14 • From the time a participant signed consent through completion of the second intervention, a total of up to 5 months.
|
|
Skin and subcutaneous tissue disorders
Bruise at Venipuncture Site
|
0.00%
0/13 • From the time a participant signed consent through completion of the second intervention, a total of up to 5 months.
|
7.1%
1/14 • Number of events 1 • From the time a participant signed consent through completion of the second intervention, a total of up to 5 months.
|
|
General disorders
Menstrual Cramps
|
7.7%
1/13 • Number of events 1 • From the time a participant signed consent through completion of the second intervention, a total of up to 5 months.
|
0.00%
0/14 • From the time a participant signed consent through completion of the second intervention, a total of up to 5 months.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
7.7%
1/13 • Number of events 1 • From the time a participant signed consent through completion of the second intervention, a total of up to 5 months.
|
7.1%
1/14 • Number of events 1 • From the time a participant signed consent through completion of the second intervention, a total of up to 5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/13 • From the time a participant signed consent through completion of the second intervention, a total of up to 5 months.
|
7.1%
1/14 • Number of events 1 • From the time a participant signed consent through completion of the second intervention, a total of up to 5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
7.7%
1/13 • Number of events 1 • From the time a participant signed consent through completion of the second intervention, a total of up to 5 months.
|
0.00%
0/14 • From the time a participant signed consent through completion of the second intervention, a total of up to 5 months.
|
|
Cardiac disorders
Heart Rate Incease Greater than 75 Percent During Exercise
|
0.00%
0/13 • From the time a participant signed consent through completion of the second intervention, a total of up to 5 months.
|
7.1%
1/14 • Number of events 1 • From the time a participant signed consent through completion of the second intervention, a total of up to 5 months.
|
Additional Information
Carole Robinette
University of North Carolina at Chapel Hill
Phone: 919-966-5638
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place