Trial Outcomes & Findings for Effect of an H1 Receptor Antagonist on Exercise Performance in Hypoxia (NCT NCT03192488)
NCT ID: NCT03192488
Last Updated: 2020-06-16
Results Overview
Time to complete 8km cycling time trial
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
13 participants
Primary outcome timeframe
Performed 60min after pill ingestion
Results posted on
2020-06-16
Participant Flow
Subjects were recruited by direct email to the administrators of the Indiana University ROTC program. It was made clear that participation of cadets was voluntary in nature and was not be a requirement of ROTC duties. Active recruitment took place from 08/2017 to 03/2018.
Enrolled participants were excluded prior to arm/group assignment if they had abnormal pulmonary function, or voluntarily discontinued with study procedures after completing a graded maximal exercise test and familiarization trial of exercise performance tests on a cycle ergometer. Two subjects withdrew prior to initial group assignments.
Participant milestones
| Measure |
Cetirizine/Hypoxia, Placebo/Hypoxia, Placebo/Normoxia
During the first visit, subjects orally ingested 10 mg of Cetirizine 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).
For the second visit, subjects orally ingested a 10 mg gelatin Placebo 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).
For the third visit, subjects orally ingested a 10 mg gelatin Placebo 60 min before exercising in a normoxic (room-air) environment (20.9% oxygen).
|
Placebo/Hypoxia, Placebo/Normoxia, Cetirizine/Hypoxia
During the first visit, subjects orally ingested a 10 mg Placebo 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).
For the second visit, subjects orally ingested a 10 mg gelatin Placebo 60 min before exercising in a normoxic (room-air) environment (20.9% oxygen).
For the third visit, subjects orally ingested 10 mg Cetirizine 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).
|
Placebo/Normoxia, Cetirizine/Hypoxia, Placebo/Hypoxia
During the first visit, subjects orally ingested a 10 mg gelatin Placebo 60 min before exercising in a normoxic (room-air) environment (20.9% oxygen).
For the second visit, subjects orally ingested 10 mg Cetirizine 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).
For the third visit, subjects orally ingested a 10 mg Placebo 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).
|
Cetirizine/Hypoxia, Placebo/Normoxia, Placebo/Hypoxia
During the first visit, subjects orally ingested 10 mg Cetirizine 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).
For the second visit, subjects orally ingested a 10 mg gelatin Placebo 60 min before exercising in a normoxic (room-air) environment (20.9% oxygen).
For the third visit, subjects orally ingested a 10 mg Placebo 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).
|
Placebo/Normoxia, Placebo/Hypoxia, Cetirizine/Hypoxia
During the first visit, subjects orally ingested a 10 mg gelatin Placebo 60 min before exercising in a normoxic (room-air) environment (20.9% oxygen).
For the second visit, subjects orally ingested a 10 mg Placebo 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).
During the third visit, subjects orally ingested 10 mg Cetirizine 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).
|
Placebo/Hypoxia, Cetirizine/Hypoxia, Placebo/Normoxia
During the first visit, subjects orally ingested a 10 mg Placebo 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).
For the second visit, subjects orally ingested 10 mg Cetirizine 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).
For the third visit, subjects orally ingested a 10 mg gelatin Placebo 60 min before exercising in a normoxic (room-air) environment (20.9% oxygen).
|
|---|---|---|---|---|---|---|
|
First Intervention (d1)
STARTED
|
1
|
5
|
2
|
1
|
1
|
1
|
|
First Intervention (d1)
COMPLETED
|
1
|
5
|
2
|
1
|
1
|
1
|
|
First Intervention (d1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
First Washout (>6d)
STARTED
|
1
|
5
|
2
|
1
|
1
|
1
|
|
First Washout (>6d)
COMPLETED
|
1
|
5
|
1
|
1
|
1
|
0
|
|
First Washout (>6d)
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Second Intervention (d1)
STARTED
|
1
|
5
|
1
|
1
|
1
|
0
|
|
Second Intervention (d1)
COMPLETED
|
1
|
5
|
1
|
1
|
1
|
0
|
|
Second Intervention (d1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Washout (>6d)
STARTED
|
1
|
5
|
1
|
1
|
1
|
0
|
|
Second Washout (>6d)
COMPLETED
|
1
|
5
|
1
|
1
|
1
|
0
|
|
Second Washout (>6d)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Intervention (d1)
STARTED
|
1
|
5
|
1
|
1
|
1
|
0
|
|
Third Intervention (d1)
COMPLETED
|
1
|
5
|
1
|
1
|
0
|
0
|
|
Third Intervention (d1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Cetirizine/Hypoxia, Placebo/Hypoxia, Placebo/Normoxia
During the first visit, subjects orally ingested 10 mg of Cetirizine 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).
For the second visit, subjects orally ingested a 10 mg gelatin Placebo 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).
For the third visit, subjects orally ingested a 10 mg gelatin Placebo 60 min before exercising in a normoxic (room-air) environment (20.9% oxygen).
|
Placebo/Hypoxia, Placebo/Normoxia, Cetirizine/Hypoxia
During the first visit, subjects orally ingested a 10 mg Placebo 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).
For the second visit, subjects orally ingested a 10 mg gelatin Placebo 60 min before exercising in a normoxic (room-air) environment (20.9% oxygen).
For the third visit, subjects orally ingested 10 mg Cetirizine 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).
|
Placebo/Normoxia, Cetirizine/Hypoxia, Placebo/Hypoxia
During the first visit, subjects orally ingested a 10 mg gelatin Placebo 60 min before exercising in a normoxic (room-air) environment (20.9% oxygen).
For the second visit, subjects orally ingested 10 mg Cetirizine 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).
For the third visit, subjects orally ingested a 10 mg Placebo 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).
|
Cetirizine/Hypoxia, Placebo/Normoxia, Placebo/Hypoxia
During the first visit, subjects orally ingested 10 mg Cetirizine 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).
For the second visit, subjects orally ingested a 10 mg gelatin Placebo 60 min before exercising in a normoxic (room-air) environment (20.9% oxygen).
For the third visit, subjects orally ingested a 10 mg Placebo 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).
|
Placebo/Normoxia, Placebo/Hypoxia, Cetirizine/Hypoxia
During the first visit, subjects orally ingested a 10 mg gelatin Placebo 60 min before exercising in a normoxic (room-air) environment (20.9% oxygen).
For the second visit, subjects orally ingested a 10 mg Placebo 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).
During the third visit, subjects orally ingested 10 mg Cetirizine 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).
|
Placebo/Hypoxia, Cetirizine/Hypoxia, Placebo/Normoxia
During the first visit, subjects orally ingested a 10 mg Placebo 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).
For the second visit, subjects orally ingested 10 mg Cetirizine 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).
For the third visit, subjects orally ingested a 10 mg gelatin Placebo 60 min before exercising in a normoxic (room-air) environment (20.9% oxygen).
|
|---|---|---|---|---|---|---|
|
First Washout (>6d)
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Third Intervention (d1)
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Subjects Completing All 3 Study Arms
n=8 Participants
Completed: Hypoxia/ Cetirizine (14.3% oxygen with 10mg cetirizine), Hypoxia/ Placebo (21% oxygen with gelatin placebo), and Normoxia/Placebo (21% oxygen with gelatin placebo)
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
20 years
STANDARD_DEVIATION 1 • n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=8 Participants
|
|
Body Fat Percentage
|
12.1 percentage
STANDARD_DEVIATION 3.9 • n=8 Participants
|
|
Body Mass Index
|
23 kg/m^2
STANDARD_DEVIATION 2 • n=8 Participants
|
|
Maximal Aerobic Capacity (VO2max)
|
44.3 ml/kg/min
STANDARD_DEVIATION 8.3 • n=8 Participants
|
|
Height
|
172 cm
STANDARD_DEVIATION 8 • n=8 Participants
|
|
Weight
|
68.3 kg
STANDARD_DEVIATION 11.1 • n=8 Participants
|
|
Physical Activity
|
441 minutes per week
STANDARD_DEVIATION 310 • n=8 Participants
|
PRIMARY outcome
Timeframe: Performed 60min after pill ingestionPopulation: Subjects who completed all three interventions were included in the outcome analysis.
Time to complete 8km cycling time trial
Outcome measures
| Measure |
Cetirizine and Hypoxia
n=8 Participants
10 mg of Cetirizine given 60 min before exercise in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).
Cetirizine: Cetirizine tablet 10 mg
|
Placebo and Hypoxia
n=8 Participants
Placebo given 60 min prior to exercise in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).
Placebo oral capsule: Gelatin placebo
|
Placebo and Normoxia
n=8 Participants
Placebo given 60 min prior to exercise in a normobaric room-air environment (21% oxygen).
Placebo oral capsule: Gelatin placebo
|
Placebo and Hypoxia (Post-Exercise)
Placebo given 60 min prior to exercise in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).
Placebo oral capsule: gelatin placebo Histamine: assessed 60 min after pill ingestion, 5-10 after 8km time trial exercise
|
Placebo and Normoxia (Baseline)
Placebo given 60 min prior to exercise in a normobaric room-air environment (21% oxygen).
Placebo oral capsule: gelatin placebo Histamine: assessed 60 min after pill ingestion, prior to exercise
|
Placebo and Normoxia (Post-Exercise)
Placebo given 60 min prior to exercise in a normobaric room-air environment (21% oxygen).
Placebo oral capsule: gelatin placebo Histamine: assessed 60 min after pill ingestion, 5-10 min following 8km time trial exercise
|
|---|---|---|---|---|---|---|
|
Performance Time
|
17.03 minutes
Standard Deviation 1.92
|
18.08 minutes
Standard Deviation 2.87
|
16.32 minutes
Standard Deviation 1.98
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and immediately post-exercise, same day as pill ingestionPopulation: Subjects included are those who completed all three intervention visits.
Plasma histamine concentrations (ng/mL) were determined baseline and post-exercise for each experimental condition. Baseline measures were taken immediately prior to exercise and the post-exercise measures were taken 5-10 minutes after the cessation of exercise.
Outcome measures
| Measure |
Cetirizine and Hypoxia
n=8 Participants
10 mg of Cetirizine given 60 min before exercise in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).
Cetirizine: Cetirizine tablet 10 mg
|
Placebo and Hypoxia
n=8 Participants
Placebo given 60 min prior to exercise in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).
Placebo oral capsule: Gelatin placebo
|
Placebo and Normoxia
n=8 Participants
Placebo given 60 min prior to exercise in a normobaric room-air environment (21% oxygen).
Placebo oral capsule: Gelatin placebo
|
Placebo and Hypoxia (Post-Exercise)
n=8 Participants
Placebo given 60 min prior to exercise in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).
Placebo oral capsule: gelatin placebo Histamine: assessed 60 min after pill ingestion, 5-10 after 8km time trial exercise
|
Placebo and Normoxia (Baseline)
n=8 Participants
Placebo given 60 min prior to exercise in a normobaric room-air environment (21% oxygen).
Placebo oral capsule: gelatin placebo Histamine: assessed 60 min after pill ingestion, prior to exercise
|
Placebo and Normoxia (Post-Exercise)
n=8 Participants
Placebo given 60 min prior to exercise in a normobaric room-air environment (21% oxygen).
Placebo oral capsule: gelatin placebo Histamine: assessed 60 min after pill ingestion, 5-10 min following 8km time trial exercise
|
|---|---|---|---|---|---|---|
|
Plasma Histamine Concentrations at Baseline and Post-Exercise
|
.36 ng/mL
Standard Deviation .14
|
.49 ng/mL
Standard Deviation .21
|
.56 ng/mL
Standard Deviation .39
|
.61 ng/mL
Standard Deviation .34
|
.37 ng/mL
Standard Deviation .09
|
.47 ng/mL
Standard Deviation .15
|
Adverse Events
Cetirizine and Hypoxia
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo and Hypoxia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo and Normoxia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cetirizine and Hypoxia
n=11 participants at risk
10 mg of Cetirizine given 60 min before exercise in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).
Cetirizine: Cetirizine tablet 10 mg
|
Placebo and Hypoxia
n=11 participants at risk
Placebo given 60 min prior to exercise in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).
Placebo oral capsule: Gelatin placebo
|
Placebo and Normoxia
n=11 participants at risk
Placebo given 60 min prior to exercise in a normobaric room-air environment (21% oxygen).
Placebo oral capsule: Gelatin placebo
|
|---|---|---|---|
|
Nervous system disorders
Fainting
|
9.1%
1/11 • Number of events 1 • Adverse event data was collected at the time of each intervention visit and for a period of up to one month following each intervention visit date.
The definition of adverse event and/or serious adverse event does not differ from clinicaltrials.gov definitions. All-cause mortality was monitored/assessed.
|
0.00%
0/11 • Adverse event data was collected at the time of each intervention visit and for a period of up to one month following each intervention visit date.
The definition of adverse event and/or serious adverse event does not differ from clinicaltrials.gov definitions. All-cause mortality was monitored/assessed.
|
0.00%
0/11 • Adverse event data was collected at the time of each intervention visit and for a period of up to one month following each intervention visit date.
The definition of adverse event and/or serious adverse event does not differ from clinicaltrials.gov definitions. All-cause mortality was monitored/assessed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place