Azelastine Allergen Chamber - Onset of Action Study

MEDA Pharma GmbH & Co. KG84 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Seasonal Allergic Rhinitis

Interventions

Treatment A: Azelastine hydrochloride 0.15% nasal spray (Azelair)DRUG

2 sprays per nostril of Azelastine 0.15% twice daily. Total dose of active drug: 1644 mcg azelastine hydrochloride per day

Treatment B: Placebo (Azelastine 0.15% vehicle) nasal sprayDRUG

2 sprays per nostril of Placebo twice daily.

Treatment C: Ryaltris (Active Control) - mometasone furoate monohydrate and olopatadine hydrochloride nasal sprayDRUG

2 sprays per nostril of Ryaltris twice daily. Total dose of active drug: 200 mcg mometasone furoate and 4800 mcg olopatadine per day

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cliantha Research

Mississauga, Ontario, Canada

Outcomes

Primary Outcomes

Change from baseline in TNSS at each post-dose assessment time point (0 to 4 hours after a single dose).

Onset of action of azelastine hydrochloride 0.15% nasal spray (Azelastine 0.15%) in treating the nasal symptoms of seasonal allergic rhinitis (SAR) induced by an allergen challenge in an Environmental Exposure Unit (EEU), measured by a difference from placebo in the change from baseline in patient -assessed instantaneous Total nasal symptom score (TNSS). FDA guideline defines onset of action as the first time point after initiation of treatment when the product demonstrated a greater change from baseline compared to placebo which proved durable. The TNSS is comprised of 4 symptoms from the nose, each scored on a scale of 0 to 3 (0 = none and 3 = severe). The sum of the TNSS contributes to a score ranging from 0 - 12.

Time frame: 0 to 4 hours post application

Secondary Outcomes

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.

Onset of action, measured by the differences of both active treatments versus placebo in the change from baseline in patient-assessed instantaneous total symptom scores following treatment. FDA guideline defines onset of action as the first time point after initiation of treatment when the product demonstrated a greater change from baseline compared to placebo which proved durable. The TNSS is comprised of 4 symptoms from the nose, each scored on a scale of 0 to 3 (0 = none and 3 = severe). The sum of the TNSS contributes to a score ranging from 0 - 12.

Time frame: 0 to 4 hours post application

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.

Onset of action, measured by the differences of both active treatments versus placebo in the change from baseline in patient-assessed instantaneous total symptom scores following treatment. FDA guideline defines onset of action as the first time point after initiation of treatment when the product demonstrated a greater change from baseline compared to placebo which proved durable. The TOSS is comprised of 3 symptoms from the eyes, each scored on a scale of 0 to 3 (0 = none and 3 = severe). The sum of the TOSS contributes to a score ranging from 0 - 9.

Data from ClinicalTrials.gov

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