Azelastine Allergen Chamber - Onset of Action Study

NCT06126952 | Completed Phase 2

• 2 other identifiers: AZEL-NS-2001C2D03217
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• 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.

  0 to 4 hours post application

Secondary Outcomes (12)

• 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.

  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.

  0 to 4 hours post application

• 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.

  0 to 4 hours post application

• 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.

  0 to 4 hours post application

• Changes from baseline in TNSS for all assessment time-points together.

  0 to 4 hours post application

Study Arms (6)

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

EXPERIMENTAL

Cross-over design

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

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

EXPERIMENTAL

Cross-over design

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

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

EXPERIMENTAL

Cross-over design

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

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

EXPERIMENTAL

Cross-over design

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

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

EXPERIMENTAL

Cross-over design

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

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

EXPERIMENTAL

Cross-over design

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

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

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

2 sprays per nostril of Placebo twice daily.

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

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

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

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MEDA Pharma GmbH & Co. KG: lead

Study Sites (1)

Cliantha Research

Mississauga, Ontario, L4W1A4, Canada

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

Nasal Sprays; azelastine; Mometasone Furoate

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aerosols; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Patricia Couroux, Dr.

  Cliantha Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study will be a single-center, randomized, placebo-controlled, double-blind trial with three periods and six sequences (cross-over design).

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 13, 2023
• Study Start: October 30, 2023
• Primary Completion: February 23, 2024
• Study Completion: March 18, 2024
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)