## Protocol Section
### Identification Module
**NCT ID:** NCT04645979

**Brief Title:** 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

**Official Title:** The Perception of Celestamine Treatment in Mexico: a Retrospective Assessment of Consumer Perception of Prior Celestamine Use

#### Organization Study ID Info
**ID:** 21614
#### Organization
**Class:** INDUSTRY
**Full Name:** Bayer
### Status Module
#### Completion Date
**Date:** 2020-11-27

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-06-01

**Type:** ACTUAL

**Last Update Submit Date:** 2023-05-31

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-11-27

**Type:** ACTUAL

#### Start Date
**Date:** 2020-11-11

**Type:** ACTUAL

**Status Verified Date:** 2023-05

#### Study First Post Date
**Date:** 2020-11-27
**Type:** ACTUAL
**Study First Submit Date:** 2020-11-23
**Study First Submit QC Date:** 2020-11-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Bayer

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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.

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 Module

**Conditions:**

- Rhinitis, Allergic

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 153

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants who used betamethasone plus loratadine to treat allergic rhinitis within the previous two months.

**Intervention Names:**

- Other: Online survey

**Label:** Participants

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Participants

**Description:** Participants will be invited to complete an online questionnaire about their experience of product use.

**Name:** Online survey

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Participants' experiences with betamethasone plus loratadine used under real life conditions.

**Measure:** Experience with betamethasone plus loratadine via an online questionnaire

**Time Frame:** 2 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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

Exclusion Criteria:

- None

**Maximum Age:** 50 Years

**Minimum Age:** 20 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Multiple Locations

**Country:** Mexico

**Facility:** Many locations

### IPD Sharing Statement Module

**Description:** 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.

**IPD Sharing:** NO

### References Module

#### See Also Links

**Label:** Click here to find results for studies related to Bayer products

**URL:** http://clinicaltrials.bayer.com/

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000007239

- Term: Infections

- ID: D000009668

- Term: Nose Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000010038

- Term: Otorhinolaryngologic Diseases

- ID: D000012130

- Term: Respiratory Hypersensitivity

- ID: D000006969

- Term: Hypersensitivity, Immediate

- ID: D000006967

- Term: Hypersensitivity

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC09

- Name: Ear, Nose, and Throat Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M15049

- Name: Rhinitis

- Relevance: HIGH

- As Found: Rhinitis

- ID: M30545

- Name: Rhinitis, Allergic

- Relevance: HIGH

- As Found: Rhinitis, Allergic

- ID: M2454

- Name: Hyperthermia

- Relevance: LOW

- As Found: Unknown

- ID: M8464

- Name: Fever

- Relevance: LOW

- As Found: Unknown

- ID: M9345

- Name: Rhinitis, Allergic, Seasonal

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M12604

- Name: Nose Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12961

- Name: Otorhinolaryngologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10018

- Name: Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M14967

- Name: Respiratory Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M10020

- Name: Hypersensitivity, Immediate

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012220

- Term: Rhinitis

- ID: D000065631

- Term: Rhinitis, Allergic

### Intervention Browse Module - Browse Branches

- Abbrev: AAll

- Name: Anti-Allergic Agents

- Abbrev: Derm

- Name: Dermatologic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: Resp

- Name: Respiratory System Agents

### Intervention Browse Module - Browse Leaves

- ID: M19623

- Name: Loratadine

- Relevance: LOW

- As Found: Unknown

- ID: M4909

- Name: Betamethasone

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
