---
title: Effects of Second-generation Antihistamine Bepotastine on Cough Outcomes in Cough Patients With Allergic Rhinitis
nct_id: NCT04877678
overall_status: COMPLETED
phase: PHASE4
sponsor: Asan Medical Center
study_type: INTERVENTIONAL
primary_condition: Allergic Rhinitis
countries: South Korea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04877678.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04877678"
ct_last_update_post_date: 2023-01-05
last_seen_at: "2026-05-12T06:45:48.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effects of Second-generation Antihistamine Bepotastine on Cough Outcomes in Cough Patients With Allergic Rhinitis

**Official Title:** Effects of Second-generation Antihistamine Bepotastine on Cough Outcomes in Cough Patients With Allergic Rhinitis: A Randomized, Double-blind, Placebo Controlled Study

**NCT ID:** [NCT04877678](https://clinicaltrials.gov/study/NCT04877678)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 50
- **Lead Sponsor:** Asan Medical Center
- **Conditions:** Allergic Rhinitis, Cough
- **Start Date:** 2021-10-01
- **Completion Date:** 2022-10-31
- **CT.gov Last Update:** 2023-01-05

## Brief Summary

This is a phase 4 study to evaluate the the efficacy of second generation antihistamine on cough outcomes in cough patients with allergic rhinitis.

## Detailed Description

This is a randomized, double blind, placebo controlled trial in which a total of 78 participants who have cough (≥ 3 weeks) and symptoms of allergic rhinitis will be enrolled. Study participants will be randomly assigned to either active treatment or placebo group. The subjects in active treatment groups will be treated with daily oral bepotastine for 2 weeks, while those in placebo group will take identical-looking tablets. The efficacy of bepotastine will be assessed at the end of 2-week intervention using leicester cough questionnaire.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1. Had a cough for at least 3 weeks (score of ≥30 mm on the VAS)
2. History or allergic rhinitis confirmed with skin prick test or serum specific IgE test AND current one or more symptoms of allergic rhinitis (runny nose, obstruction, sneezing, nasal itching)
3. Provided written informed consent
4. Were willing and able to comply with the study protocol

Exclusion Criteria:

1. Current smoker or individuals who have smoked within the past 1 month prior to study entry
2. Sings of coexisting respiratory diseases requiring active treatment such as fever, chills, wheezing, dyspnea, or purulent sputum
3. Currently under allergen immunotherapy
4. 1\) Allergic rhinitis or chronic rhinosinusitis under treatment with intranasal corticosteroids (INS) or leukotriene receptor antagonist (LTRA) or 2) allergic rhinitis requiring treatment with INS or LTRA
5. Treatment with an angiotensin converting enzyme (ACE)-inhibitor within 4 weeks prior to the enrollment
6. Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) \< 0.7 or FEV1 % of predicted \< 80% within 1 month prior to enrollment
7. Abnormal findings on chest x-ray related to cough within 1 month prior to enrollment
8. Diagnosis or treatment of bronchial asthma or COPD within 1 year of the enrollment
9. Clinically significant medical conditions possibly affecting evaluation of cough and nasal symptoms
10. History of hypersensitivity or severe adverse reaction to antihistamines
11. Unable to fill in the questionnaires (blindness, unable to read)
12. Unable to provide informed consent
13. History of taking following medication within 2 weeks of the enrollment; LTRA, nasal decongestants, intranasal corticosteroids (INS), systemic corticosteroids, antitussive agents (OTCs, codeine)
```

## Arms

- **Treatment group** (ACTIVE_COMPARATOR) — Participants will be treated with bepotastine.
- **Placebo group** (PLACEBO_COMPARATOR) — Participants will be treated with identical looking placebo.

## Interventions

- **Bepotastine** (DRUG) — 10 mg Bepotastine, twice a day
- **Placebo** (DRUG) — Identical looking placebo, twice a day

## Primary Outcomes

- **Leicester Cough Questionnaire (LCQ)** _(time frame: At baseline, and at 2 weeks of treatment)_ — The total score range of Leicester Cough Questionnaire is from 3 to 21. A higher score indicates a better quality of life.

## Secondary Outcomes

- **Visual analogue scale (VAS) of cough** _(time frame: At baseline, and at 2 weeks of treatment)_
- **Cough hypersensitivity questionnaire (CHQ)** _(time frame: At baseline, and at 2 weeks of treatment)_
- **Sino-nasal outcome test -22 (SNOT-22)** _(time frame: At baseline, and at 2 weeks of treatment)_
- **Visual analogue scale (VAS) of globus pharyngeus** _(time frame: At baseline, and at 2 weeks of treatment)_
- **Daily cough severity** _(time frame: daily assessment)_
- **Rate of adverse events** _(time frame: during 2 weeks of treatment)_
- **Objective cough frequency** _(time frame: At baseline, and at 2 weeks of treatment)_

## Locations (1)

- Asan medical center, Seoul, South Korea

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.asan medical center|seoul||south korea` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT04877678*  
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