Concomitant Intranasal Antihistamine and Corticosteroid i... | NCT05708157

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

NCT05708157

Sponsor

Gachon University Gil Medical Center

Status

Unknown status

Last Update Posted

Feb 1, 2023Actual

Enrollment

240Estimated

Phase

Not provided

Conditions

Allergic Rhinitis

Interventions

concomitant intranasal antihistamine and corticosteroid

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 17, 2023Actual

Primary Completion Date

Feb 29, 2024Estimated

Completion Date

Feb 29, 2024Estimated

First Submitted Date

Jan 23, 2023

First Submission Date that Met QC Criteria

Jan 23, 2023

First Posted Date

Feb 1, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2023

Last Update Posted Date

Feb 1, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sangmin Lee, MD, Professor, Gachon University Gil Medical CenterPrincipal Investigator

Lead Sponsor

Gachon University Gil Medical CenterOTHER

Collaborators

Name	Class
Hallym University Kangnam Sacred Heart Hospital	OTHER
Gangneung Asan Hospital	OTHER
Bundang Jesaeng Hospital	UNKNOWN
Chung-Ang University Gwangmyeong Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

240Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active group		Patients with perennial allergic rhinitis who receive concomitant intranasal antihistamine and corticosteroid.	Drug: concomitant intranasal antihistamine and corticosteroid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
concomitant intranasal antihistamine and corticosteroid	Drug	concomitant intranasal administration with antihistamine and corticosteroid	Active group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
TNSS	total nasal symptom score	2 week

Secondary Outcomes

Measure	Description	Time Frame
TOSS	total nasal symptom score	2 week
RQLQ	rhinoconjunctivitis quality-of-life questionnares	2 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with perennial allergic rhinitis whose symptoms are not controlled by 2-week treatement with intranasal corticosteroid.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sang Min Lee, MD, PhD	Contact	82324582713		sangminlee77@naver.com

Overall Officials

Name	Affiliation	Role
Sang Min Lee, MD, PhD	Gachon University Gil Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gachon University Gil Medical Center	Recruiting	Incheon		21565	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35716356	Background	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.

ID	Term
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D012130	Respiratory Hypersensitivity

ID	Term
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists