check_circleStudy Completed

Allergic rhinitis

Study to find out how long it takes Azelastine Hydrochloride 0.15% Nasal Spray to relieve symptoms in patients suffering from allergic rhinitis

Trial purpose

In this study researchers want to learn how quickly patients suffering from allergic rhinitis (also known as hay fever) can expect symptom relief after using Azelastine Hydrochloride 0.15% Nasal Spray.
This study plans to enrol about 80 male or female participants in the age of 18 to 65 years suffering from an allergic rhinitis to ragweed pollen for at least 2 years. In a first phase participants will be exposed to ragweed pollen in a special study room to ensure they will be adequately symptomatic when they progress into the treatment phase of the study. In a second phase study participants will be divided in 2 groups. After exposure to ragweed pollen one group will receive Azelastine Hydrochloride 0.15% Nasal Spray and the other group will receive placebo (a nasal spray which does not contain any active drug substance). In the third phase of study the treatment will be switched: participants who received in the previous study Azelastine Hydrochloride 0.15% Nasal Spray will receive the nasal spray without any active drug substance and the other group will receive Azelastine Hydrochloride 0.15% Nasal Spray. During the second and third study phase the researchers will examine thoroughly over 4 hours the change of nasal symptoms such as runny nose, itchy nose, sneezing and nasal congestion after participants received the nasal spray.

Key Participants Requirements

Sex

All

Age

18 - 65 Years

Trial summary

Enrollment Goal
110
Trial Dates
February 2020 - March 2021
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Astelin/Astepro (Azelastine hydrochloride, BAYR9258)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Cliantha ResearchMississauga, L4W 1A4, Canada

Primary Outcome

  • Total nasal symptom score (TNSS)
    Evaluated by rating the following symptoms (sneezing, runny nose, itchy nose, and nasal congestion) on a scale from 0-3 (0 = None, 1= Mild symptoms, 2 = Moderate symptoms, 3 = Severe symptoms)
    date_rangeTime Frame:
    4 hours post dose

Trial design

A Randomized, Double-Blind, Placebo Controlled, Crossover Study to Evaluate the Onset of Efficacy of Azelastine Hydrochloride 0.15% Nasal Spray in Allergic Rhinitis Sufferers Following Pollen Exposure in an Environmental Exposure Chamber
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Crossover Assignment
Trial Arms
2