Azelastine Allergen Chamber - Onset of Action Study

Meda Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Seasonal Allergic Rhinitis

Treatments: Drug: Treatment B: Placebo (Azelastine 0.15% vehicle) nasal spray; Drug: Treatment C: Ryaltris (Active Control) - mometasone furoate monohydrate and olopatadine hydrochloride nasal spray; Drug: Treatment A: Azelastine hydrochloride 0.15% nasal spray (Azelair)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06126952

C2D03217 (Other Identifier)

AZEL-NS-2001

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

84 participants in 6 patient groups

Treatment A (Azelair)+Treatment B (Placebo)+Treatment C (Ryaltris), min. 14 days wash-out period

Experimental group

Description:

Cross-over design

Treatment:

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

Drug: Treatment B: Placebo (Azelastine 0.15% vehicle) nasal spray

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

Treatment B (Placebo)+Treatment C (Ryaltris)+Treatment A (Azelair), min. 14 days of wash-out period

Experimental group

Description:

Cross-over design

Treatment:

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

Drug: Treatment B: Placebo (Azelastine 0.15% vehicle) nasal spray

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

Treatment C (Ryaltris)+Treatment A (Azelair)+Treatment B (Placebo), min. 14 days of wash-out period

Experimental group

Description:

Cross-over design

Treatment:

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

Drug: Treatment B: Placebo (Azelastine 0.15% vehicle) nasal spray

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

Treatment A (Azelair)+Treatment C (Ryaltris)+Treatment B (Placebo), min. 14 days of wash-out period

Experimental group

Description:

Cross-over design

Treatment:

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

Drug: Treatment B: Placebo (Azelastine 0.15% vehicle) nasal spray

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

Treatment B (Placebo)+Treatment A (Azelair)+Treatment C (Ryaltris), min.14 days of wash-out period

Experimental group

Description:

Cross-over design

Treatment:

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

Drug: Treatment B: Placebo (Azelastine 0.15% vehicle) nasal spray

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

Treatment C (Ryaltris)+Treatment B (Placebo)+Treatment A (Azelair), min. 14 days of wash-out period

Experimental group

Description:

Cross-over design

Treatment:

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

Drug: Treatment B: Placebo (Azelastine 0.15% vehicle) nasal spray

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