INCS/INAH: Concomitant Intranasal Antihistamine and Corticosteroid in Stepwise Treatment Strategy for Allergic Rhinitis

• Sponsor: Gachon University Gil Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05708157
• Collaborator: Hallym University Kangnam Sacred Heart Hospital (Other), Gangneung Asan Hospital (Other), Bundang Jesaeng Hospital (Other), Chung-Ang University Gwangmyeong Hospital (Other), Hallym University Medical Center (Other)
• Enrollment: 240
• Location: 1
• Anticipated Duration (Months): 13.4
• Patients Per Site Per Month: 17.9

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Allergic Rhinitis	Drug: concomitant intranasal antihistamine and corticosteroid

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

• Study Type: Observational
• Anticipated Enrollment: 240 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Therapeutic Role of Concomitant Intranasal Antihistamine and Corticosteroid in Patient With Perennial Allergic Rhinitis Whose Symptoms Are Not Controlled With Intranasal Corticosteroid
• Actual Study Start Date: Jan 17, 2023
• Anticipated Primary Completion Date: Feb 29, 2024
• Anticipated Study Completion Date: Feb 29, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active group Patients with perennial allergic rhinitis who receive concomitant intranasal antihistamine and corticosteroid.	Drug: concomitant intranasal antihistamine and corticosteroid; concomitant intranasal administration with antihistamine and corticosteroid

Outcome Measures

Primary Outcome Measures

1. TNSS [2 week]

   total nasal symptom score

Secondary Outcome Measures

1. TOSS [2 week]

   total nasal symptom score

2. RQLQ [2 week]

   rhinoconjunctivitis quality-of-life questionnares

3. VAS [2 week]

   visual analogue scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gachon University Gil Medical Center	Incheon		Korea, Republic of	21565

Sponsors and Collaborators

• Gachon University Gil Medical Center
• Hallym University Kangnam Sacred Heart Hospital
• Gangneung Asan Hospital
• Bundang Jesaeng Hospital
• Chung-Ang University Gwangmyeong Hospital
• Hallym University Medical Center

Investigators

• Principal Investigator: Sang Min Lee, MD, PhD, Gachon University Gil Medical Center

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Sangmin Lee, MD, Professor, Gachon University Gil Medical Center
• ClinicalTrials.gov Identifier: NCT05708157
• Other Study ID Numbers: GCIRB2022-327
• First Posted: Feb 1, 2023
• Last Update Posted: Feb 1, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Rhinitis; Rhinitis, Allergic; Histamine Antagonists; Histamine H1 Antagonists

Study Results

No Results Posted as of Feb 1, 2023