Clinical trial NCT06126952: Azelastine Allergen Chamber - Onset of Action Study
Official title: Randomized, Double-blind, Cross-over Clinical Trial to Assess Onset of Action and Efficacy of Azelastine Hydrochloride 0.15% Nasal Spray in the Treatment of Allergen-Induced Allergic Rhinitis Symptoms in an Environmental Exposure Unit in Comparison to Placebo and Mometasone Furoate/Olopatadine Hydrochloride Nasal Spray
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2023-11-13
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study will be a single-center, randomized, placebo-controlled, double-blind trial with three periods and six sequences (cross-over design).
Primary purpose: TREATMENT

Brief summary: This study is to assess the Onset of Action and Efficacy of azelastine hydrochloride 0.15% in treating the nasal symptoms of seasonal allergic rhinitis (SAR) induced by an allergen challenge in an Environmental Exposure Unit (EEU) followed by a single dose and a 3-day treatment at home.


Eligibility criteria: Main Inclusion Criteria:

* Male or female subjects (childbearing and non-childbearing potential, non-childbearing potential defined as females with no menstruation for at least 1 year at screening and documented FSH \> 35 IU/L) aged 18 to 55 years (inclusive) at screening.
* History of SAR to ragweed pollen for at least the previous 2 ragweed pollen seasons.
* Positive skin prick test (SPT) response to ragweed pollen (allergen induced wheal diameter at least 3 mm larger than the negative control). A test performed at Cliantha Research in the previous 12 months may be used to qualify the subject.

Main Exclusion Criteria:

Safety Concerns:

* History of allergic reaction to azelastine hydrochloride, olopatadine hydrochloride, mometasone furoate, or one of the excipients / components of the study treatments
* History of anaphylaxis, cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, metabolic, psychiatric, neurological, or other disease at screening that may affect subject safety during the study or evaluation of the study endpoints at the discretion of the Investigator and/or designee.
* Subjects with a current diagnosis of asthma or subjects with measured forced expiratory volume in 1 second (FEV1) \<75% of the predicted value using Global Lung Function Initiative set from 2012 for references.
* Pregnant, breast-feeding, or planning a pregnancy during the study and women of childbearing potential not using adequate contraception.

Lack of suitability for the study:

* Use of prohibited therapies as specified in the respective table of the protocol.
* Acute or chronic sinusitis or non-allergic rhinitis, at the discretion of the Investigator and/or designee.

Primary outcomes:
measure: Change from baseline in TNSS at each post-dose assessment time point (0 to 4 hours after a single dose).
timeFrame: 0 to 4 hours post application
Secondary outcomes:
measure: Changes from baseline in TNSS at each post-dose assessment time point (0 to 4 hours after a single dose) at Visits 3, 6, and 9.
timeFrame: 0 to 4 hours post application
measure: Changes from baseline in TOSS at each post-dose assessment time point (0 to 4 hours after a single dose) at Visits 3, 6, and 9.
timeFrame: 0 to 4 hours post application
measure: Changes from baseline in T7SS at each post-dose assessment time point (0 to 4 hours after a single dose) at Visits 3, 6, and 9.
timeFrame: 0 to 4 hours post application
measure: Change from baseline in individual symptom scores at each post-dose assessment time point (0 to 4 hours after a single dose) at Visits 3, 6, and 9.
timeFrame: 0 to 4 hours post application
measure: Changes from baseline in TNSS for all assessment time-points together.
timeFrame: 0 to 4 hours post application
measure: Changes from baseline in TOSS for all assessment time-points together.
timeFrame: 0 to 4 hours post application
measure: Changes from baseline in T7SS for all assessment time-points together.
timeFrame: 0 to 4 hours post application
measure: Change from baseline in individual symptom scores for all assessment time-points together.
timeFrame: 0 to 4 hours post application
measure: Changes from baseline in TNSS for all assessment time-points together.
timeFrame: 0-4 hours after 3-day treatment
measure: Changes from baseline in TOSS for all assessment time-points together.
timeFrame: 0-4 hours after 3-day treatment
measure: Changes from baseline in T7SS for all assessment time-points together.
timeFrame: 0-4 hours after 3-day treatment
measure: Change from baseline in individual symptom scores for all assessment time-points together.
timeFrame: 0-4 hours after 3-day treatment
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Cliantha Research
state: Ontario
Study officials:
affiliation: Cliantha Research
name: Patricia Couroux, Dr.
role: PRINCIPAL_INVESTIGATOR
References: