Concomitant Intranasal Antihistamine and Corticosteroid in Stepwise Treatment Strategy for Allergic Rhinitis

Allergic Rhinitis Clinical Trial

— INCS/INAH  

Official title:

Therapeutic Role of Concomitant Intranasal Antihistamine and Corticosteroid in Patient With Perennial Allergic Rhinitis Whose Symptoms Are Not Controlled With Intranasal Corticosteroid

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05708157
• Other study ID #: GCIRB2022-327
• Status: Recruiting
• Start date: January 17, 2023
• Est. completion date: February 29, 2024

Study information

• Verified date: January 2023
• Source: Gachon University Gil Medical Center
• Contact: Sang Min Lee, MD, PhD
• Phone: 82324582713
• Email: sangminlee77[@]naver.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• concomitant intranasal antihistamine and corticosteroid
concomitant intranasal administration with antihistamine and corticosteroid

Locations

Country	Name	City	State
Korea, Republic of	Gachon University Gil Medical Center	Incheon

Sponsors (6)

Lead Sponsor	Collaborator
Gachon University Gil Medical Center	Bundang Jesaeng Hospital, Chung-Ang University Gwangmyeong Hospital, Gangneung Asan Hospital, Hallym University Kangnam Sacred Heart Hospital, Hallym University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TNSS	total nasal symptom score	2 week
Secondary	TOSS	total nasal symptom score	2 week
Secondary	RQLQ	rhinoconjunctivitis quality-of-life questionnares	2 week
Secondary	VAS	visual analogue scale	2 week