Allergic RhinitisPhase 4NCT04162795
A Study to Evaluate Cooling Sensation of an Allergy Product in Adults With a History of Allergies
A Phase 4 study testing Loratadine (Claritin, BAY76-2211) in people with Allergic Rhinitis, run by Bayer at 1 site in United States.
Trial summary
In this study, researchers were primarily interested in evaluating the level of agreement of cooling sensation provided by this chewable, flavored, allergy medicine. Participants joining this study received one test drug tablet and were asked to chew completely before swallowing the drug. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Loratadine (Claritin, BAY76-2211)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 468 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2019to 13 Nov 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male adults aged 18 to 65 years of age inclusive
- Were in good general health
- Previous self-reported sufferers of upper respiratory allergies who at the time of the study are either asymptomatic, symptomatic but not treating and agree to use study medication or symptomatic and treating with an allergy medicine that is not an antihistamine
- Agreed to not use antihistamine products 24 hours before and after the treatment
- Willing to avoid eating food or candy (other than crackers consumed during testing), drinking any liquid other than water, gum chewing and teeth brushing one hour prior to testing
Who cannot join
- Individuals who had used oral/systemic medications 24 hours before the first administration of test product
- Individuals who used medications which might influence taste perception
- Individuals who had received or used an investigational new drug in the last 30 days or had been an active participant in another clinical or market research study in the last 30 days
- Women who were pregnant or thinking of becoming pregnant or were nursing
- Participants with congestion at the time of study visit
- Any self-reported symptoms or conditions that might interfere with the participants ability to complete the evaluation of the product on testing day
Show all 11Show fewer
- Any current medical condition that in the opinion of the Investigator or designee might interfere with normal taste and/or temperature perception (e.g., active common cold, sinus infection, bronchial infection, adenoids, paresthesia etc.)
- History of alcohol or drug abuse
- History of hypersensitivity or allergic reactions to any ingredients in the test product
- Individuals with a history of glaucoma, liver or kidney disease, respiratory conditions such as chronic bronchitis or swallowing difficulties
- Individuals who were currently wearing any kind of dental braces or with dental work or had cavities and associated pain that might affect their ability to chew a tablet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Multi-center Study to Evaluate Sensory Attributes of an Antihistamine Product
In this study, researchers were primarily interested in evaluating the level of agreement of cooling sensation provided by this chewable, flavored, allergy medicine. Participants joining this study received one test drug tablet and were asked to chew completely before swallowing the drug. A questionnaire was used to collect the feedback from participants. The study involved only one (1) visit and participant stayed in this study for about 60-75 minutes to evaluate the cooling sensation as well as other sensory attributes perceived in the mouth, nose and throat.
- Conditions
- Allergic Rhinitis
- Being tested
- Loratadine (Claritin, BAY76-2211)
- Keywords
- Allergy, Upper respiratory allergies
- Medical subject headings
- Rhinitis, Allergic, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loratadine (Claritin, BAY76-2211)Drug
Chewable tablet, oral, single dose
| Study group | Role | What they receive |
|---|---|---|
| Loratadine chewable tablet | Experimental | Participants received one dose of loratadine chewable tablet to chew completely before swallowing. Receives: Drug: Loratadine (Claritin, BAY76-2211) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Agreement of Perception of Cooling Sensation
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.
Measured: Up to 5 minutes post ingestion of study medication
Secondary outcomes (10)
Proportion of Participants With Agreement of Perception of Cooling Sensation Per Location
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.
Measured: Up to 5 minutes post ingestion of study medication
Proportion of Participants With Agreement of Perception of Refreshing Sensation
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.
Measured: Up to 5 minutes post ingestion of study medication
Proportion of Participants With Agreement of the Refreshing of the Cooling Sensation
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.
Measured: Up to 5 minutes post ingestion of study medication
Proportion of Participants With Agreement of the Unique Sensory Experience for an Allergy Medicine
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.
Measured: Up to 5 minutes post ingestion of study medication
Proportion of Participants With Agreement of Soothing Feeling on the Throat
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.
Measured: Up to 5 minutes post ingestion of study medication
Proportion of Participants With Agreement of Liking the Flavor Sensation of the Product
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.
Measured: Up to 5 minutes post ingestion of study medication
Proportion of Participants With Agreement of the Enjoyable Product Experience
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.
Measured: Up to 5 minutes post ingestion of study medication
Proportion of Participants With Agreement of the Great Taste of the Product
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.
Measured: Up to 5 minutes post ingestion of study medication
Time to Perception of Cooling Sensation
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.
Measured: Up to 60 minutes post ingestion of study medication
Duration of Cooling Sensation
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.
Measured: Up to 60 minutes post ingestion of study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start12 Nov 2019
- Primary completion13 Nov 2019
- Study completion13 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 468 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162795
- Sponsor's protocol ID
- 21048
- Status last verified
- Jan 2021
- First submitted
- 12 Nov 2019
- Last updated
- 4 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multi-center Study to Evaluate Sensory Attributes of an Antihistamine Product
- ClinicalTrials.gov ID
- NCT04162795
- Acronym / sponsor ID
- 21048
- Conditions
- Allergic Rhinitis
- Keywords
- Allergy, Upper respiratory allergies
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 468 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 13 Nov 2019 (actual)
- Study completion
- 13 Nov 2019 (actual)
- First posted
- 14 Nov 2019 (actual)
- Results
- Posted 4 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, researchers were primarily interested in evaluating the level of agreement of cooling sensation provided by this chewable, flavored, allergy medicine. Participants joining this study received one test drug tablet and were asked to chew completely before swallowing the drug. A questionnaire was used to collect the feedback from participants. The study involved only one (1) visit and participant stayed in this study for about 60-75 minutes to evaluate the cooling sensation as well as other sensory attributes perceived in the mouth, nose and throat.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Loratadine chewable tablet | Experimental | Drug: Loratadine (Claritin, BAY76-2211)Participants received one dose of loratadine chewable tablet to chew completely before swallowing. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female or male adults aged 18 to 65 years of age inclusive
- Were in good general health
- Previous self-reported sufferers of upper respiratory allergies who at the time of the study are either asymptomatic, symptomatic but not treating and agree to use study medication or symptomatic and treating with an allergy medicine that is not an antihistamine
- Agreed to not use antihistamine products 24 hours before and after the treatment
- Willing to avoid eating food or candy (other than crackers consumed during testing), drinking any liquid other than water, gum chewing and teeth brushing one hour prior to testing
Key exclusion criteria (11 listed)
- Individuals who had used oral/systemic medications 24 hours before the first administration of test product
- Individuals who used medications which might influence taste perception
- Individuals who had received or used an investigational new drug in the last 30 days or had been an active participant in another clinical or market research study in the last 30 days
- Women who were pregnant or thinking of becoming pregnant or were nursing
- Participants with congestion at the time of study visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Loratadine (Claritin, BAY76-2211)Chewable tablet, oral, single dose | Drug | Loratadine chewable tablet |
Primary outcome
Proportion of Participants With Agreement of Perception of Cooling Sensation
Time frame: Up to 5 minutes post ingestion of 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.
10 secondary outcomes
Proportion of Participants With Agreement of Perception of Cooling Sensation Per Location
Time frame: Up to 5 minutes post ingestion of study medication
Proportion of Participants With Agreement of Perception of Refreshing Sensation
Time frame: Up to 5 minutes post ingestion of study medication
Proportion of Participants With Agreement of the Refreshing of the Cooling Sensation
Time frame: Up to 5 minutes post ingestion of study medication
Proportion of Participants With Agreement of the Unique Sensory Experience for an Allergy Medicine
Time frame: Up to 5 minutes post ingestion of study medication
Proportion of Participants With Agreement of Soothing Feeling on the Throat
Time frame: Up to 5 minutes post ingestion of study medication
Proportion of Participants With Agreement of Liking the Flavor Sensation of the Product
Time frame: Up to 5 minutes post ingestion of study medication
Proportion of Participants With Agreement of the Enjoyable Product Experience
Time frame: Up to 5 minutes post ingestion of study medication
Proportion of Participants With Agreement of the Great Taste of the Product
Time frame: Up to 5 minutes post ingestion of study medication
Time to Perception of Cooling Sensation
Time frame: Up to 60 minutes post ingestion of study medication
Duration of Cooling Sensation
Time frame: Up to 60 minutes post ingestion of study medication
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Loratadine (Claritin, BAY76-2211) in people with Allergic Rhinitis, run by Bayer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With Agreement of Perception of Cooling Sensation (time frame: Up to 5 minutes post ingestion of study medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.