Allergic RhinitisINCS/INAHNCT05708157
Concomitant Intranasal Antihistamine and Corticosteroid in Stepwise Treatment Strategy for Allergic Rhinitis
An observational study of Allergic Rhinitis, run by Gachon University Gil Medical Center at 1 site in South Korea.
Trial summary
Patients with perennial allergic rhinitis whose symptoms are not controlled (visual analogue scale [VAS] ≥5) by 2-week treatment with intranasal corticosteroid will receive concomitant intranasal antihistamine and corticosteroid for 2 weeks. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- concomitant intranasal antihistamine and corticosteroid
- How many people
- 240 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Jan 2023to 29 Feb 2024
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with perennial allergic rhinitis whose symptoms are not controlled by 2-week treatement with intranasal corticosteroid.
Who may be able to join
- Perinnial allergic rhinitis diagnosed by a doctor
- Positive for one or more of inhalant perinneal allergen in skin prick test or serum specific IgE measurement
- Age: 19 years or older
- Allergic rhinitis symptoms not controlled (VAS ≥5) by 2-week treatment with intranasal corticosteroid
Who cannot join
- Compliance for one or more drugs in last 2 weeks: <80%
- Use of oral corticosteroid, oral or intranasal decongestant in last 2 weeks
- Initiation of allergen-specific immunotherapy in last 12 months
- Seasonal allergic rhinitis
- Chronic rhinosinusitis other than allergic rhinitis
- Nasal polyposis
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- Comorbid diseases including infectious, respiratory, cardiologic, renal, gastrointestinal, endocrinologic, oncologic, hemotologic and immunologic disorders which investigators judge to affect on the study significantly.
- Patients' rejection
- Pregenancy or lactation
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gachon University Gil Medical Center
Incheon, 21565
Sang Min Lee, MD, PhD, 82324582713, sangminlee77@naver.com
Sang Min Lee, MD, PhD
About this study
Official title: Therapeutic Role of Concomitant Intranasal Antihistamine and Corticosteroid in Patient With Perennial Allergic Rhinitis Whose Symptoms Are Not Controlled With Intranasal Corticosteroid
Patients with perennial allergic rhinitis whose symptoms are not controlled (visual analogue scale [VAS] ≥5) by 2-week treatment with intranasal corticosteroid will receive concomitant intranasal antihistamine and corticosteroid for 2 weeks. After 2-week treatment, changes in clinical parameters including VAS, total nasal symptom score (TNSS), total ocular symptom score (TOSS), rhinoconjunctivitis quality-of-life questionnaires (RQLQ) will be evaluated.
Read the detailed description
Patients with perennial allergic rhinitis whose symptoms are not controlled (visual analogue scale [VAS] ≥5) by 2-week treatment with intranasal corticosteroid will receive concomitant intranasal antihistamine and corticosteroid. In addition to VAS, total nasal symptom score (TNSS), total ocular symptom score (TOSS), rhinoconjunctivitis quality-of-life questionnaires (RQLQ) will be measured before treatment (baseline) and 2 week after treatment. The differences between parameters before treatment and those after 2-week treatment will be statistically analyzed using paired student t test, and p<0.05 was considered statistically significant.
- Conditions
- Allergic Rhinitis
- Being tested
- concomitant intranasal antihistamine and corticosteroid
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
concomitant intranasal antihistamine and corticosteroidDrug
concomitant intranasal administration with antihistamine and corticosteroid
| Study group | Role | What they receive |
|---|---|---|
| Active group | Patients with perennial allergic rhinitis who receive concomitant intranasal antihistamine and corticosteroid. Receives: Drug: concomitant intranasal antihistamine and corticosteroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
TNSS
total nasal symptom score
Measured: 2 week
Secondary outcomes (3)
TOSS
total nasal symptom score
Measured: 2 week
RQLQ
rhinoconjunctivitis quality-of-life questionnares
Measured: 2 week
VAS
visual analogue scale
Measured: 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start17 Jan 2023
- Primary completion29 Feb 2024 (estimated)
- Study completion29 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Hallym University Kangnam Sacred Heart Hospital, Gangneung Asan Hospital, Bundang Jesaeng Hospital, Chung-Ang University Gwangmyeong Hospital, Hallym University Medical Center
- Responsible party
- Principal investigator, Sangmin Lee, MD, Gachon University Gil Medical Center
- Investigators
- Sang Min Lee, MD, PhD, Principal investigator, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708157
- Sponsor's protocol ID
- GCIRB2022-327
- Acronym
- INCS/INAH
- Status last verified
- Jan 2023
- First submitted
- 23 Jan 2023
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim M, Ryu G, Kang SY, Kim MA, Yang SI, Lee IH, Choi GS, Kim HJ, Lee SM, Kim DK, Choi JH, Yang HJ, Kim SW; Work Group for Rhinitis, the Korean Academy of Asthma, Allergy and Clinical Immunology. Intranasal antihistamine and corticosteroid to treat allergic rhinitis: A systematic review and meta-analysis. Allergy. 2022 Nov;77(11):3436-3440. doi: 10.1111/all.15415. Epub 2022 Jul 8. No abstract available.
PubMed 35716356
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Role of Concomitant Intranasal Antihistamine and Corticosteroid in Patient With Perennial Allergic Rhinitis Whose Symptoms Are Not Controlled With Intranasal Corticosteroid
- ClinicalTrials.gov ID
- NCT05708157
- Acronym / sponsor ID
- INCS/INAH / GCIRB2022-327
- Conditions
- Allergic Rhinitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Collaborators
- Hallym University Kangnam Sacred Heart Hospital, Gangneung Asan Hospital, Bundang Jesaeng Hospital, Chung-Ang University Gwangmyeong Hospital, Hallym University Medical Center
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 29 Feb 2024 (estimated)
- Study completion
- 29 Feb 2024 (estimated)
- First posted
- 1 Feb 2023 (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.
Patients with perennial allergic rhinitis whose symptoms are not controlled (visual analogue scale [VAS] ≥5) by 2-week treatment with intranasal corticosteroid will receive concomitant intranasal antihistamine and corticosteroid for 2 weeks. After 2-week treatment, changes in clinical parameters including VAS, total nasal symptom score (TNSS), total ocular symptom score (TOSS), rhinoconjunctivitis quality-of-life questionnaires (RQLQ) will be evaluated.
Detailed description
Patients with perennial allergic rhinitis whose symptoms are not controlled (visual analogue scale [VAS] ≥5) by 2-week treatment with intranasal corticosteroid will receive concomitant intranasal antihistamine and corticosteroid. In addition to VAS, total nasal symptom score (TNSS), total ocular symptom score (TOSS), rhinoconjunctivitis quality-of-life questionnaires (RQLQ) will be measured before treatment (baseline) and 2 week after treatment. The differences between parameters before treatment and those after 2-week treatment will be statistically analyzed using paired student t test, and p<0.05 was considered statistically significant.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active group | – | Drug: concomitant intranasal antihistamine and corticosteroidPatients with perennial allergic rhinitis who receive concomitant intranasal antihistamine and corticosteroid. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with perennial allergic rhinitis whose symptoms are not controlled by 2-week treatement with intranasal corticosteroid.
Key inclusion criteria (4 listed)
- Perinnial allergic rhinitis diagnosed by a doctor
- Positive for one or more of inhalant perinneal allergen in skin prick test or serum specific IgE measurement
- Age: 19 years or older
- Allergic rhinitis symptoms not controlled (VAS ≥5) by 2-week treatment with intranasal corticosteroid
Key exclusion criteria (9 listed)
- Compliance for one or more drugs in last 2 weeks: <80%
- Use of oral corticosteroid, oral or intranasal decongestant in last 2 weeks
- Initiation of allergen-specific immunotherapy in last 12 months
- Seasonal allergic rhinitis
- Chronic rhinosinusitis other than allergic rhinitis
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 |
|---|---|---|
| concomitant intranasal antihistamine and corticosteroidconcomitant intranasal administration with antihistamine and corticosteroid | Drug | Active group |
Primary outcome
TNSS
Time frame: 2 week
total nasal symptom score
3 secondary outcomes
TOSS
Time frame: 2 week
RQLQ
Time frame: 2 week
VAS
Time frame: 2 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Background: PubMed 35716356Kim M, Ryu G, Kang SY, Kim MA, Yang SI, Lee IH, Choi GS, Kim HJ, Lee SM, Kim DK, Choi JH, Yang HJ, Kim SW; Work Group for Rhinitis, the Korean Academy of Asthma, Allergy and Clinical Immunology. Intranasal antihistamine and corticosteroid to treat allergic rhinitis: A systematic review and meta-analysis. Allergy. 2022 Nov;77(11):3436-3440. doi: 10.1111/all.15415. Epub 2022 Jul 8. No abstract available.
- Individual participant dataSharing planned: No
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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.
Sang Min Lee, MD, PhD principal investigator
Gachon University Gil Medical Center
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 Allergic Rhinitis, run by Gachon University Gil 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 9 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: status not confirmed, as of the sponsor's last update on 1 Feb 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sang Min Lee, MD, PhD (82324582713, sangminlee77@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TNSS (time frame: 2 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05708157, which also lists 1 linked publication.
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 Feb 2023.