Trial Outcomes & Findings for The Effect of Cetirizine HCl on Exercise-induced Arterial Hypoxemia in Highly-trained Swimmers (NCT NCT05095311)
NCT ID: NCT05095311
Last Updated: 2024-03-05
Results Overview
SpO2 percentage measured via a standard bedside pulse oximetry unit
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
16 participants
Primary outcome timeframe
In the final minute of the aerobic capacity test and each of the two (70% and 85% of max) constant load trials in Visits 3 and 4 of the study
Results posted on
2024-03-05
Participant Flow
The recruitment period lasted from March 2021 through April 2022. Participants were connected to the investigators through their coach, and participants were asked to schedule a screening visit (Visit 1) if desired.
The experimental arm of the study was limited to those participants who wanted to continue with the study and responded to correspondence from investigators.
Participant milestones
| Measure |
Initial Phase Only
Twenty-four total individuals will be recruited for the initial portion of the study, and the aforementioned 12 (6 men, 6 women) will be a subset of the initial 24. The other 12 participants will not take part in further study.
|
Initial Phase, Then Cetirizine HCl First, Then Placebo
This subset of 12 individuals will complete all experimental study visits, and will ingest either 1) a cetirizine HCl pill (10 mg) then 2) a placebo pill in double-blind fashion.
Cetirizine HCl: Eight participants will be administered 10 mg of cetirizine HCl to examine whether this drug can improve their oxyhemoglobin saturation during exercise.
Placebo: The placebo pill is a sugar-free gelatin pill casing.
|
Initial Phase, Then Placebo First, Then Cetirizine HCl
This subset of 12 individuals will complete all experimental study visits, and will ingest either 1) a placebo pill then 2) a cetirizine HCl pill (10 mg) in double-blind fashion.
Cetirizine HCl: Eight participants will be administered 10 mg of cetirizine HCl to examine whether this drug can improve their oxyhemoglobin saturation during exercise.
Placebo: The placebo pill is a sugar-free gelatin pill casing.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
2
|
2
|
|
Overall Study
COMPLETED
|
5
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
7
|
0
|
0
|
Reasons for withdrawal
| Measure |
Initial Phase Only
Twenty-four total individuals will be recruited for the initial portion of the study, and the aforementioned 12 (6 men, 6 women) will be a subset of the initial 24. The other 12 participants will not take part in further study.
|
Initial Phase, Then Cetirizine HCl First, Then Placebo
This subset of 12 individuals will complete all experimental study visits, and will ingest either 1) a cetirizine HCl pill (10 mg) then 2) a placebo pill in double-blind fashion.
Cetirizine HCl: Eight participants will be administered 10 mg of cetirizine HCl to examine whether this drug can improve their oxyhemoglobin saturation during exercise.
Placebo: The placebo pill is a sugar-free gelatin pill casing.
|
Initial Phase, Then Placebo First, Then Cetirizine HCl
This subset of 12 individuals will complete all experimental study visits, and will ingest either 1) a placebo pill then 2) a cetirizine HCl pill (10 mg) in double-blind fashion.
Cetirizine HCl: Eight participants will be administered 10 mg of cetirizine HCl to examine whether this drug can improve their oxyhemoglobin saturation during exercise.
Placebo: The placebo pill is a sugar-free gelatin pill casing.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
0
|
0
|
Baseline Characteristics
The Effect of Cetirizine HCl on Exercise-induced Arterial Hypoxemia in Highly-trained Swimmers
Baseline characteristics by cohort
| Measure |
Experimental Group
n=4 Participants
This subset of 12 individuals will complete all experimental study visits, and will ingest either 1) a placebo pill and placebo inhaler contents or 2) a cetirizine HCl pill (10 mg) and placebo inhaler contents in a randomized order and double-blind fashion.
Cetirizine HCl: Eight participants will be administered 10 mg of cetirizine HCl to examine whether this drug can improve their oxyhemoglobin saturation during exercise.
Placebo: The placebo pill is a sugar-free gelatin pill casing. The placebo inhaler contains isotonic saline.
|
Selection Pool
n=12 Participants
Twenty-four total individuals will be recruited for the initial portion of the study, and the aforementioned 12 (6 men, 6 women) will be a subset of the initial 24. The other 12 participants will not take part in further study.
|
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
|
4 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
20.0 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
20.1 years
STANDARD_DEVIATION 1.9 • n=7 Participants
|
20.1 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
15 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
|
4 participants
n=5 Participants
|
12 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Forced Vital Capacity (FVC)
|
6.76 liters
STANDARD_DEVIATION 0.91 • n=5 Participants
|
6.87 liters
STANDARD_DEVIATION 1.17 • n=7 Participants
|
6.85 liters
STANDARD_DEVIATION 1.09 • n=5 Participants
|
|
Forced Expiratory Volume in 1 Second (FEV1)
|
4.92 liters
STANDARD_DEVIATION 0.67 • n=5 Participants
|
5.40 liters
STANDARD_DEVIATION 0.86 • n=7 Participants
|
5.28 liters
STANDARD_DEVIATION 0.82 • n=5 Participants
|
|
Forced Mid-Expiratory Flow (FEF25-75%)
|
3.88 liters
STANDARD_DEVIATION 0.60 • n=5 Participants
|
5.08 liters
STANDARD_DEVIATION 1.11 • n=7 Participants
|
4.78 liters
STANDARD_DEVIATION 1.12 • n=5 Participants
|
|
Peak Expiratory Flow (PEF)
|
10.14 liters per second
STANDARD_DEVIATION 1.75 • n=5 Participants
|
9.21 liters per second
STANDARD_DEVIATION 1.29 • n=7 Participants
|
9.45 liters per second
STANDARD_DEVIATION 1.42 • n=5 Participants
|
PRIMARY outcome
Timeframe: In the final minute of the aerobic capacity test and each of the two (70% and 85% of max) constant load trials in Visits 3 and 4 of the studyPopulation: These individuals are from the Experimental group.
SpO2 percentage measured via a standard bedside pulse oximetry unit
Outcome measures
| Measure |
Placebo
n=4 Participants
The placebo pill is a sugar-free gelatin pill casing. The placebo inhaler contains isotonic saline.
|
Cetirizine HCl
n=4 Participants
10 mg of cetirizine HCl to examine whether this drug can improve their oxyhemoglobin saturation during exercise.
|
|---|---|---|
|
Peripheral Capillary Oxyhemoglobin Saturation
70% constant load
|
98.2 percent hemoglobin saturation
Standard Deviation 1.8
|
98.5 percent hemoglobin saturation
Standard Deviation 1.1
|
|
Peripheral Capillary Oxyhemoglobin Saturation
85% constant load
|
98.8 percent hemoglobin saturation
Standard Deviation 1.3
|
97.9 percent hemoglobin saturation
Standard Deviation 1.4
|
|
Peripheral Capillary Oxyhemoglobin Saturation
Aerobic capacity test
|
96.8 percent hemoglobin saturation
Standard Deviation 1.3
|
98.0 percent hemoglobin saturation
Standard Deviation 1.8
|
Adverse Events
Initial Phase
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cetirizine HCl
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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