Rhinitis, AllergicNCT04645979
A Study to Learn What Participants Think of Treatment With Betamethasone Plus Loratadine to Treat Their Acute Allergic Rhinitis, Also Known as Hay Fever in Mexico
An observational study of Rhinitis, Allergic, run by Bayer at 1 site in Mexico.
Trial summary
Acute allergic rhinitis is a common allergic reaction to things like pollen or dust. It causes inflammation inside the nose, resulting in symptoms similar to the common cold. Allergic rhinitis is also known as hay fever. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Rhinitis, Allergic
- What is being tested?
- Online survey
- How many people
- 153 participants
- Where
- 1 siteMexico
- Study dates
- 11 Nov 2020to 27 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study population are participants who used betamethasone plus loratadine within the previous 2 months for the treatment of acute episodes of allergic rhinitis.
Who may be able to join
- Participants who used betamethasone plus loratadine within the previous 2 months for the treatment of acute episodes of allergic rhinitis
- Participants allowing to use the data for research and marketing purposes as well as talking to authorities
- Participants allowing us to use the pseudo-randomized individual data for further data analysis
- Able to read and understand the language of the online questionnaire
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Perception of Celestamine Treatment in Mexico: a Retrospective Assessment of Consumer Perception of Prior Celestamine Use
Acute allergic rhinitis is a common allergic reaction to things like pollen or dust. It causes inflammation inside the nose, resulting in symptoms similar to the common cold. Allergic rhinitis is also known as hay fever.
In this study, the researchers want to learn what participants think of betamethasone plus loratadine as a treatment for their acute allergic rhinitis. These participants will have used betamethasone plus loratadine as a treatment for their acute allergic rhinitis within the past two months. During the study, participants will complete an online questionnaire about their experience with betamethasone plus loratadine.
- Conditions
- Rhinitis, Allergic
- Being tested
- Online survey
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online surveyOther
Participants will be invited to complete an online questionnaire about their experience of product use.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Participants who used betamethasone plus loratadine to treat allergic rhinitis within the previous two months. Receives: Other: Online survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experience with betamethasone plus loratadine via an online questionnaire
Participants' experiences with betamethasone plus loratadine used under real life conditions.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start11 Nov 2020
- Primary completion27 Nov 2020
- Study completion27 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, AllergicStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645979
- Sponsor's protocol ID
- 21614
- Status last verified
- May 2023
- First submitted
- 23 Nov 2020
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Perception of Celestamine Treatment in Mexico: a Retrospective Assessment of Consumer Perception of Prior Celestamine Use
- ClinicalTrials.gov ID
- NCT04645979
- Acronym / sponsor ID
- 21614
- Conditions
- Rhinitis, Allergic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 27 Nov 2020 (actual)
- Study completion
- 27 Nov 2020 (actual)
- First posted
- 27 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute allergic rhinitis is a common allergic reaction to things like pollen or dust. It causes inflammation inside the nose, resulting in symptoms similar to the common cold. Allergic rhinitis is also known as hay fever.
In this study, the researchers want to learn what participants think of betamethasone plus loratadine as a treatment for their acute allergic rhinitis. These participants will have used betamethasone plus loratadine as a treatment for their acute allergic rhinitis within the past two months. During the study, participants will complete an online questionnaire about their experience with betamethasone plus loratadine.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Other: Online surveyParticipants who used betamethasone plus loratadine to treat allergic rhinitis within the previous two months. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population are participants who used betamethasone plus loratadine within the previous 2 months for the treatment of acute episodes of allergic rhinitis.
Key inclusion criteria (4 listed)
- Participants who used betamethasone plus loratadine within the previous 2 months for the treatment of acute episodes of allergic rhinitis
- Participants allowing to use the data for research and marketing purposes as well as talking to authorities
- Participants allowing us to use the pseudo-randomized individual data for further data analysis
- Able to read and understand the language of the online questionnaire
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Online surveyParticipants will be invited to complete an online questionnaire about their experience of product use. | Other | Participants |
Primary outcome
Experience with betamethasone plus loratadine via an online questionnaire
Time frame: 2 months
Participants' experiences with betamethasone plus loratadine used under real life conditions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Individual participant dataSharing planned: No. 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?
An observational study of Rhinitis, Allergic, run by Bayer at 1 site in Mexico.
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 4 inclusion and 1 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 1 Jun 2023. 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 Mexico. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Experience with betamethasone plus loratadine via an online questionnaire (time frame: 2 months). 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 1 Jun 2023.