NCT04729517

Brief Summary

This is a prospective, national, randomized, multicenter, parallel group, Phase III study that evaluates the effects of AI201901 in Allergic Rhinitis patients, where they will spray twice a day against azelastine into both nostrils during a 28-day follow-up period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 28, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

April 20, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2023

Completed
Last Updated

September 8, 2023

Status Verified

August 1, 2022

Enrollment Period

1.9 years

First QC Date

January 20, 2021

Last Update Submit

September 6, 2023

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
  • To have a related complaint for at least 2 years
  • To be informed about the study and to give consent to participate in the study

You may not qualify if:

  • Diagnosis of superficial nasal mucosal erosion, moderate nasal mucosal erosion, nasal mucosal ulceration and nasal septum perforation during nasal examination
  • Presence of nasal diseases that are likely to affect the accumulation of intranasal drugs, such as acute or chronic sinusitis, rhinitis medicamentosa, clinically significant polyposis or clinically significant nasal structural abnormalities
  • Having undergone a nasal or sinus surgery for up to one year before the study
  • The use of any investigational drug within 30 days prior to Visit 1;
  • Known hypersensitivity to components of the products used in the study
  • Presence of respiratory infections, which have developed within the two weeks prior to Visit 1
  • Diagnosis of COPD
  • Use of alcohol and other drugs (antidepressants) that have a negative effect on reaction time / concurrent use of sedative drugs or other drugs that act on the central nervous system
  • Presence of chronic obstructive sleep-apnea syndrome (clinical diagnosis)
  • Presence of any surgical or medical condition, which, according to the opinion of the responsible researcher, could significantly alter the absorption, distribution, metabolism, or excretion of the investigational product, or could significantly affect the patient's ability to complete this study
  • Presence of symptoms in the medical history in relation to glaucoma, cataract, ocular herpes simplex, conjunctivitis, or other ocular infections
  • Presence of medical history in relation to active or latent tuberculosis
  • Presence or risk of exposure to chickenpox or measles within the last 30 days
  • Presence of untreated fungi, bacteria or systemic viral infection within the last 30 days
  • Being pregnant or breastfeeding
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

azelastine

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The first group will receive AI201901 , whereas the second group will receive azelastine hydrochloride. Patients that will receive AI201901 are defined as the test arm and patients that will receive azelastine hydrochloride are defined as the active control arm.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2021

First Posted

January 28, 2021

Study Start

April 20, 2021

Primary Completion

March 3, 2023

Study Completion

May 2, 2023

Last Updated

September 8, 2023

Record last verified: 2022-08

Locations

TU(1)