Allergic RhinitisPhase 4NCT04877678
Effects of Second-generation Antihistamine Bepotastine on Cough Outcomes in Cough Patients With Allergic Rhinitis
A Phase 4 study testing Bepotastine in people with Allergic Rhinitis and Cough, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Allergic Rhinitis, Cough
- What is being tested?
- Bepotastine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2021to 31 Oct 2022
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Had a cough for at least 3 weeks (score of ≥30 mm on the VAS)
- 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)
- Provided written informed consent
- Were willing and able to comply with the study protocol
Who cannot join
- Current smoker or individuals who have smoked within the past 1 month prior to study entry
- Sings of coexisting respiratory diseases requiring active treatment such as fever, chills, wheezing, dyspnea, or purulent sputum
- Currently under allergen immunotherapy
- 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
- Treatment with an angiotensin converting enzyme (ACE)-inhibitor within 4 weeks prior to the enrollment
- Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) < 0.7 or FEV1 % of predicted < 80% within 1 month prior to enrollment
Show all 13Show fewer
- Abnormal findings on chest x-ray related to cough within 1 month prior to enrollment
- Diagnosis or treatment of bronchial asthma or COPD within 1 year of the enrollment
- Clinically significant medical conditions possibly affecting evaluation of cough and nasal symptoms
- History of hypersensitivity or severe adverse reaction to antihistamines
- Unable to fill in the questionnaires (blindness, unable to read)
- Unable to provide informed consent
- History of taking following medication within 2 weeks of the enrollment; LTRA, nasal decongestants, intranasal corticosteroids (INS), systemic corticosteroids, antitussive agents (OTCs, codeine)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Second-generation Antihistamine Bepotastine on Cough Outcomes in Cough Patients With Allergic Rhinitis: A Randomized, Double-blind, Placebo Controlled Study
This is a phase 4 study to evaluate the the efficacy of second generation antihistamine on cough outcomes in cough patients with allergic rhinitis.
Read the 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.
- Conditions
- Allergic Rhinitis, Cough
- Being tested
- Bepotastine, Placebo
- Keywords
- cough, allergic rhinitis, antihistamines
- Medical subject headings
- Rhinitis, Allergic, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BepotastineDrug
Also called Beposta B
10 mg Bepotastine, twice a day
PlaceboDrug
Identical looking placebo, twice a day
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Active comparator | Participants will be treated with bepotastine. Receives: Drug: Bepotastine |
| Placebo group | Placebo comparator | Participants will be treated with identical looking placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leicester Cough Questionnaire (LCQ)
The total score range of Leicester Cough Questionnaire is from 3 to 21. A higher score indicates a better quality of life.
Measured: At baseline, and at 2 weeks of treatment
Secondary outcomes (7)
Visual analogue scale (VAS) of cough
The visual analogue scale of cough ranges from 0-100. A higher score indicates more severe cough.
Measured: At baseline, and at 2 weeks of treatment
Cough hypersensitivity questionnaire (CHQ)
The total score of cough hypersensitivity questionnaire ranges from 0-23. A higher score indicates a greater number of sensations or triggers associated with cough (or a higher degree of cough hypersensitivity).
Measured: At baseline, and at 2 weeks of treatment
Sino-nasal outcome test -22 (SNOT-22)
The total score of sino-nasal outcome test -22 ranges from 0-110. A higher score indicates worse quality of life related to nasal symptoms.
Measured: At baseline, and at 2 weeks of treatment
Visual analogue scale (VAS) of globus pharyngeus
The visual analogue scale of globus pharyngeus ranges from 0-100. A higher score indicates more severe sensation of globus pharyngeus.
Measured: At baseline, and at 2 weeks of treatment
Daily cough severity
The scale of daily cough severity ranges from 0-10. A higher score indicates more severe cough.
Measured: daily assessment
Rate of adverse events
Rate of adverse events in participant
Measured: during 2 weeks of treatment
Objective cough frequency
24-hour objective cough frequency will be measured using the Hyfe Cough Tracker, a smartphone application-based cough monitoring. The measurement is optional and will be done in patients who agree to measure it.
Measured: At baseline, and at 2 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start1 Oct 2021
- Primary completion1 Sep 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized, Double-blind, Placebo Controlled Study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Woo-Jung Song, Asan Medical Center
- Investigators
- Woo-Jung Song, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877678
- Sponsor's protocol ID
- 2021-0363
- Status last verified
- Jan 2023
- First submitted
- 4 May 2021
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Second-generation Antihistamine Bepotastine on Cough Outcomes in Cough Patients With Allergic Rhinitis: A Randomized, Double-blind, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT04877678
- Acronym / sponsor ID
- 2021-0363
- Conditions
- Allergic Rhinitis, Cough
- Keywords
- cough, allergic rhinitis, antihistamines
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 7 May 2021 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A Randomized, Double-blind, Placebo Controlled Study
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Active comparator | Drug: BepotastineParticipants will be treated with bepotastine. |
| Placebo group | Placebo comparator | Drug: PlaceboParticipants will be treated with identical looking placebo. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Had a cough for at least 3 weeks (score of ≥30 mm on the VAS)
- 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)
- Provided written informed consent
- Were willing and able to comply with the study protocol
Key exclusion criteria (13 listed)
- Current smoker or individuals who have smoked within the past 1 month prior to study entry
- Sings of coexisting respiratory diseases requiring active treatment such as fever, chills, wheezing, dyspnea, or purulent sputum
- Currently under allergen immunotherapy
- 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
- Treatment with an angiotensin converting enzyme (ACE)-inhibitor within 4 weeks prior to the enrollment
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 |
|---|---|---|
| BepotastineAlso: Beposta B10 mg Bepotastine, twice a day | Drug | Treatment group |
| PlaceboIdentical looking placebo, twice a day | Drug | Placebo group |
Primary outcome
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.
7 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
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 5 Jan 2023.
- Individual participant dataSharing planned: No
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Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
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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.
Woo-Jung Song principal investigator
Asan Medical Center
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 Bepotastine in people with Allergic Rhinitis and Cough, run by Asan Medical Center at 1 site in South Korea.
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 13 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 5 Jan 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 South Korea. 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. Some participants in this study may receive a placebo. 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?
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?
Leicester Cough Questionnaire (LCQ) (time frame: At baseline, and at 2 weeks of treatment). 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 5 Jan 2023; AzTrials last refreshed its copy on 7 Nov 2026.