Trials Sponsors Conditions Drugs Pricing

Conditions

Allergic Rhinitis Due to Allergens

Keywords

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

Total Nasal Symptom Score
Achieve a statistically significant improvement in the symptoms of allergic rhinitis via Total Nasal Symptom Score (TNSS).
28 days

Secondary Outcomes (7)

TNNSS; Total non nasal symptom score
28 days
The rhinoconjunctivitis quality of life scale (RQLQ)
28 days
Odor Visual Analogue Score (VAS)
28 days
Inspiratory peak flow meter (PNIF)
28 days
Connecticut butanol odor threshold test
28 days
+2 more secondary outcomes

Study Arms (2)

Azelastine Hydrochloride

ACTIVE COMPARATOR

Patients that will receive azelastine hydrochloride are defined as the active control arm.

Drug: Azelastine Hydrochloride

AI201901

EXPERIMENTAL

Patients that will receive AI201901 are defined as the test arm.

Drug: AI201901

Interventions

AI201901Drug

Twice daily inhaled AI201901 for 4 weeks

AI201901

Azelastine HydrochlorideDrug

Twice daily inhaled Azelastine Hydrochloride for 4 weeks

Also known as: Allergodil

Azelastine Hydrochloride

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

To be diagnosed as allergic rhinitis on the basis of medical history, physical examination, and skin prick test, and according to ARIA 2008 criteria
To be included in seasonal and perennial allergic rhinitis group

Sponsors & Collaborators

Umraniye Education and Research Hospital
Governmentcollaborator
Diskapi Yildirim Beyazit Education and Research Hospital
Governmentcollaborator

Study Sites (1)

Dokuz Eylul University

Izmir, Turkey (Türkiye)

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

azelastine

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Enrollment

210 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 20, 2021

First Posted

January 28, 2021

Study Start

Efficacy and Safety Study of AI201901 in Allergic Rhinitis Patients

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

Azelastine Hydrochloride

AI201901

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

Azelastine Hydrochloride

AI201901

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations