Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
84 participants
INTERVENTIONAL
2023-10-30
2024-03-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Treatment A (Azelair)+Treatment B (Placebo)+Treatment C (Ryaltris), min. 14 days wash-out period
Cross-over design
Treatment A: Azelastine hydrochloride 0.15% nasal spray (Azelair)
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 spray
2 sprays per nostril of Placebo twice daily.
Treatment C: Ryaltris (Active Control) - mometasone furoate monohydrate and olopatadine hydrochloride nasal spray
2 sprays per nostril of Ryaltris twice daily.
Total dose of active drug:
200 mcg mometasone furoate and 4800 mcg olopatadine per day
Treatment B (Placebo)+Treatment C (Ryaltris)+Treatment A (Azelair), min. 14 days of wash-out period
Cross-over design
Treatment A: Azelastine hydrochloride 0.15% nasal spray (Azelair)
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 spray
2 sprays per nostril of Placebo twice daily.
Treatment C: Ryaltris (Active Control) - mometasone furoate monohydrate and olopatadine hydrochloride nasal spray
2 sprays per nostril of Ryaltris twice daily.
Total dose of active drug:
200 mcg mometasone furoate and 4800 mcg olopatadine per day
Treatment C (Ryaltris)+Treatment A (Azelair)+Treatment B (Placebo), min. 14 days of wash-out period
Cross-over design
Treatment A: Azelastine hydrochloride 0.15% nasal spray (Azelair)
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 spray
2 sprays per nostril of Placebo twice daily.
Treatment C: Ryaltris (Active Control) - mometasone furoate monohydrate and olopatadine hydrochloride nasal spray
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 C (Ryaltris)+Treatment B (Placebo), min. 14 days of wash-out period
Cross-over design
Treatment A: Azelastine hydrochloride 0.15% nasal spray (Azelair)
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 spray
2 sprays per nostril of Placebo twice daily.
Treatment C: Ryaltris (Active Control) - mometasone furoate monohydrate and olopatadine hydrochloride nasal spray
2 sprays per nostril of Ryaltris twice daily.
Total dose of active drug:
200 mcg mometasone furoate and 4800 mcg olopatadine per day
Treatment B (Placebo)+Treatment A (Azelair)+Treatment C (Ryaltris), min.14 days of wash-out period
Cross-over design
Treatment A: Azelastine hydrochloride 0.15% nasal spray (Azelair)
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 spray
2 sprays per nostril of Placebo twice daily.
Treatment C: Ryaltris (Active Control) - mometasone furoate monohydrate and olopatadine hydrochloride nasal spray
2 sprays per nostril of Ryaltris twice daily.
Total dose of active drug:
200 mcg mometasone furoate and 4800 mcg olopatadine per day
Treatment C (Ryaltris)+Treatment B (Placebo)+Treatment A (Azelair), min. 14 days of wash-out period
Cross-over design
Treatment A: Azelastine hydrochloride 0.15% nasal spray (Azelair)
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 spray
2 sprays per nostril of Placebo twice daily.
Treatment C: Ryaltris (Active Control) - mometasone furoate monohydrate and olopatadine hydrochloride nasal spray
2 sprays per nostril of Ryaltris twice daily.
Total dose of active drug:
200 mcg mometasone furoate and 4800 mcg olopatadine per day
Interventions
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Treatment A: Azelastine hydrochloride 0.15% nasal spray (Azelair)
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 spray
2 sprays per nostril of Placebo twice daily.
Treatment C: Ryaltris (Active Control) - mometasone furoate monohydrate and olopatadine hydrochloride nasal spray
2 sprays per nostril of Ryaltris twice daily.
Total dose of active drug:
200 mcg mometasone furoate and 4800 mcg olopatadine per day
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
55 Years
ALL
No
Sponsors
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MEDA Pharma GmbH & Co. KG
INDUSTRY
Responsible Party
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Principal Investigators
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Patricia Couroux, Dr.
Role: PRINCIPAL_INVESTIGATOR
Cliantha Research
Locations
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Cliantha Research
Mississauga, Ontario, Canada
Countries
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Other Identifiers
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C2D03217
Identifier Type: OTHER
Identifier Source: secondary_id
AZEL-NS-2001
Identifier Type: -
Identifier Source: org_study_id
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