Trial Outcomes & Findings for A Study to Evaluate Cooling Sensation of an Allergy Product in Adults With a History of Allergies (NCT NCT04162795)

NCT ID: NCT04162795

Last Updated: 2021-02-04

Results Overview

Participants were asked to response to question "the product provides a cooling sensation" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of perception of the sensation.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

468 participants

Primary outcome timeframe

Up to 5 minutes post ingestion of study medication

Results posted on

2021-02-04

Participant Flow

Study was conducted at multiple centers in the US between 12 November 2019 (first participant first visit) and 13 November 2019 (last participant last visit).

Overall, 468 participants were screened. Of them, 10 participants were screen failures and 16 participants did not complete the study with early termination. 442 participants received study treatment and completed the study.

Participant milestones

Participant milestones
Measure	Loratadine Chewable Tablet Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
Overall Study STARTED	468
Overall Study COMPLETED	442
Overall Study NOT COMPLETED	26

Reasons for withdrawal

Reasons for withdrawal
Measure	Loratadine Chewable Tablet Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
Overall Study Other	16
Overall Study Screen failures	10

Baseline Characteristics

A Study to Evaluate Cooling Sensation of an Allergy Product in Adults With a History of Allergies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Loratadine Chewable Tablet n=442 Participants Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
Age, Customized 18- 34 years	30 Percentage of participants n=5 Participants
Age, Customized 35- 44 years	30 Percentage of participants n=5 Participants
Age, Customized 45- 54 years	26 Percentage of participants n=5 Participants
Age, Customized 55+ years	14 Percentage of participants n=5 Participants
Sex/Gender, Customized Male	46 Percentage of participants n=5 Participants
Sex/Gender, Customized Female	54 Percentage of participants n=5 Participants
Race/Ethnicity, Customized White	52 Percentage of participants n=5 Participants
Race/Ethnicity, Customized Black/African American	33 Percentage of participants n=5 Participants
Race/Ethnicity, Customized Hispanic	12 Percentage of participants n=5 Participants
Race/Ethnicity, Customized Asian	5 Percentage of participants n=5 Participants
Race/Ethnicity, Customized Other races	2 Percentage of participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 5 minutes post ingestion of study medication

Population: All participants who received the study medication and had an evaluation data for study medication

Participants were asked to response to question "the product provides a cooling sensation" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of perception of the sensation.

Outcome measures

Outcome measures
Measure	Loratadine Chewable Tablet n=442 Participants Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
Proportion of Participants With Agreement of Perception of Cooling Sensation	0.99 Proportion of participants Interval 0.98 to 1.0

SECONDARY outcome

Timeframe: Up to 5 minutes post ingestion of study medication

Population: All participants who received the study medication and had an evaluation data for study medication

Participants were asked to respond to question "the product provides a cooling sensation in the mouth, nose or throat" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of perception of the sensation.

Outcome measures

Outcome measures
Measure	Loratadine Chewable Tablet n=442 Participants Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
Proportion of Participants With Agreement of Perception of Cooling Sensation Per Location Cooling in Mouth	0.99 Proportion of participants Interval 0.98 to 1.0
Proportion of Participants With Agreement of Perception of Cooling Sensation Per Location Cooling in Nose	0.71 Proportion of participants Interval 0.67 to 0.76
Proportion of Participants With Agreement of Perception of Cooling Sensation Per Location Cooling in Throat	0.93 Proportion of participants Interval 0.9 to 0.95

SECONDARY outcome

Timeframe: Up to 5 minutes post ingestion of study medication

Population: All participants who received the study medication and had an evaluation data for study medication

Participants were asked to response to question "the product provides a refreshing sensation" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of perception of the sensation.

Outcome measures

Outcome measures
Measure	Loratadine Chewable Tablet n=442 Participants Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
Proportion of Participants With Agreement of Perception of Refreshing Sensation Refreshing	0.96 Proportion of participants Interval 0.94 to 0.98
Proportion of Participants With Agreement of Perception of Refreshing Sensation ...Refreshing in Mouth	0.96 Proportion of participants Interval 0.94 to 0.97
Proportion of Participants With Agreement of Perception of Refreshing Sensation ...Refreshing in Nose	0.61 Proportion of participants Interval 0.57 to 0.66
Proportion of Participants With Agreement of Perception of Refreshing Sensation ...Refreshing in Throat	0.88 Proportion of participants Interval 0.85 to 0.91

SECONDARY outcome

Timeframe: Up to 5 minutes post ingestion of study medication

Population: All participants who received the study medication and had an evaluation data for study medication

Participants were asked to response to question "the cooling sensation is refreshing" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of the refreshing of the cooling sensation.

Outcome measures

Outcome measures
Measure	Loratadine Chewable Tablet n=442 Participants Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
Proportion of Participants With Agreement of the Refreshing of the Cooling Sensation	0.96 Proportion of participants Interval 0.94 to 0.97

SECONDARY outcome

Timeframe: Up to 5 minutes post ingestion of study medication

Population: All participants who received the study medication and had an evaluation data for study medication

Participants were asked to response to question "the sensory experience is unique for an allergy medicine" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of the unique sensory experience sensation.

Outcome measures

Outcome measures
Measure	Loratadine Chewable Tablet n=442 Participants Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
Proportion of Participants With Agreement of the Unique Sensory Experience for an Allergy Medicine	0.94 Proportion of participants Interval 0.92 to 0.96

SECONDARY outcome

Timeframe: Up to 5 minutes post ingestion of study medication

Population: All participants who received the study medication and had an evaluation data for study medication

Participants were asked to response to question "the product feels soothing on the throat" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of the soothing feeling.

Outcome measures

Outcome measures
Measure	Loratadine Chewable Tablet n=442 Participants Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
Proportion of Participants With Agreement of Soothing Feeling on the Throat	0.89 Proportion of participants Interval 0.86 to 0.92

SECONDARY outcome

Timeframe: Up to 5 minutes post ingestion of study medication

Population: All participants who received the study medication and had an evaluation data for study medication

Participants were asked to response to question "I like the flavor sensation of the product" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of liking the enjoyable flavor sensation.

Outcome measures

Outcome measures
Measure	Loratadine Chewable Tablet n=442 Participants Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
Proportion of Participants With Agreement of Liking the Flavor Sensation of the Product	0.87 Proportion of participants Interval 0.83 to 0.9

SECONDARY outcome

Timeframe: Up to 5 minutes post ingestion of study medication

Population: All participants who received the study medication and had an evaluation data for study medication

Participants were asked to response to question "the product experience was enjoyable" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of the enjoyable experience.

Outcome measures

Outcome measures
Measure	Loratadine Chewable Tablet n=442 Participants Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
Proportion of Participants With Agreement of the Enjoyable Product Experience	0.85 Proportion of participants Interval 0.81 to 0.88

SECONDARY outcome

Timeframe: Up to 5 minutes post ingestion of study medication

Population: All participants who received the study medication and had an evaluation data for study medication

Participants were asked to response to question "the product tastes great" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of the great taste.

Outcome measures

Outcome measures
Measure	Loratadine Chewable Tablet n=442 Participants Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
Proportion of Participants With Agreement of the Great Taste of the Product	0.77 Proportion of participants Interval 0.73 to 0.81

SECONDARY outcome

Timeframe: Up to 60 minutes post ingestion of study medication

Population: All participants who received the study medication and had an evaluation data for study medication

The mean time point at which cooling was initially perceived was claimed as the onset of cooling. The mean onsets of cooling sensation in the mouth, nose and throat were reported.

Outcome measures

Outcome measures
Measure	Loratadine Chewable Tablet n=442 Participants Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
Time to Perception of Cooling Sensation Cooling in Mouth	5.82 Seconds Interval 5.33 to 6.32
Time to Perception of Cooling Sensation Cooling in Nose	14.97 Seconds Interval 13.0 to 16.94
Time to Perception of Cooling Sensation Cooling in Throat	16.17 Seconds Interval 14.43 to 17.91

SECONDARY outcome

Timeframe: Up to 60 minutes post ingestion of study medication

Population: All participants who received the study medication and had an evaluation data for study medication

Participants who reported that they never experienced a cooling sensation were not included in the model. Those for whom the cooling sensation extended for 60 minutes or more were considered right-censored and were treated as such in the model. The median time of cooling sensation in the mouth, nose and throat was reported. Dispersion values were not calculated for this sensory study.

Outcome measures

Outcome measures
Measure	Loratadine Chewable Tablet n=442 Participants Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
Duration of Cooling Sensation Cooling in Mouth	20 Minutes The analysis of duration of cooling sensation was based on a Kaplan-Meier survival model. The Kaplan-Meier figures are included in the study report but cannot be provided in this data set. The specific dispersion values are not included in the study report or source tables for this sensory study.
Duration of Cooling Sensation Cooling in Nose	20 Minutes The analysis of duration of cooling sensation was based on a Kaplan-Meier survival model. The Kaplan-Meier figures are included in the study report but cannot be provided in this data set. The specific dispersion values are not included in the study report or source tables for this sensory study.
Duration of Cooling Sensation Cooling in the Throat	15 Minutes The analysis of duration of cooling sensation was based on a Kaplan-Meier survival model. The Kaplan-Meier figures are included in the study report but cannot be provided in this data set. The specific dispersion values are not included in the study report or source tables for this sensory study.

Adverse Events

Loratadine Chewable Tablet

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Loratadine Chewable Tablet n=442 participants at risk Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.23% 1/442 • From the signing of the informed consent form (ICF) until discharge from the study site (1 day)
Gastrointestinal disorders Vomiting	0.23% 1/442 • From the signing of the informed consent form (ICF) until discharge from the study site (1 day)
Infections and infestations Rhinitis	0.23% 1/442 • From the signing of the informed consent form (ICF) until discharge from the study site (1 day)
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	0.45% 2/442 • From the signing of the informed consent form (ICF) until discharge from the study site (1 day)
Gastrointestinal disorders Salivary duct inflammation	0.23% 1/442 • From the signing of the informed consent form (ICF) until discharge from the study site (1 day)
Gastrointestinal disorders Dyspepsia	0.45% 2/442 • From the signing of the informed consent form (ICF) until discharge from the study site (1 day)
Respiratory, thoracic and mediastinal disorders Rhinorrhea	0.23% 1/442 • From the signing of the informed consent form (ICF) until discharge from the study site (1 day)
Eye disorders Ocular sensory symptom	0.23% 1/442 • From the signing of the informed consent form (ICF) until discharge from the study site (1 day)

Additional Information

Therapeutic Area Head

Bayer

Phone: 1-888-8422937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60