Status:
COMPLETED
Azelastine Allergen Chamber - Onset of Action Study
Lead Sponsor:
MEDA Pharma GmbH & Co. KG
Conditions:
Seasonal Allergic Rhinitis
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
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 Env...
Eligibility Criteria
Inclusion
- Main
- 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
- 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.
Key Trial Info
Start Date :
October 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2024
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT06126952
Start Date
October 30 2023
End Date
March 18 2024
Last Update
March 20 2024
Active Locations (1)
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1
Cliantha Research
Mississauga, Ontario, Canada, L4W1A4