Study to Find Out How Long it Takes Azelastine Hydrochloride 0.15% Nasal Spray to Relieve Symptoms in Patients Suffering From Allergic Rhinitis

This is an interventional treatment trial for Allergic Rhinitis Read More

Inclusion Criteria:

• Healthy, ambulatory, male or female volunteers 18 to 65 years of age with selfreported allergic rhinitis to ragweed pollen for at least 2 years prior.
• Documented positive skin prick test response to common ragweed (ambrosia artemisiifolia) pollen; prick with wheal ≥3 mm larger than the diluent response at screening or within the previous 12 months done at the research site.
• Subject is willing to abstain use of any decongestant and/or allergy medications (prescription and over-the-counter), smoking, wearing perfume and alcohol 24 hours prior to the Qualification and Treatment Phases as instructed.
• Subject is willing to stop use of current decongestant and allergy medications at the start of the washout period prior to qualification and during the trial as instructed.
• At the discretion of the investigator, subjects may be considered with self-reported mild intermittent asthma (using ≤2 doses of SABA (short-acting beta agonists) per week) or exercise-induced asthma.
• Female subjects of childbearing potential must: a) be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives); b) abstain from sexual intercourse for at least 1 month prior to screening; or c) participate exclusively in a same sex relationship for at least 1 month prior to screening. In addition, female subjects of childbearing potential must have a negative pregnancy test at Screening and prior to entering the Environmental Exposure Chamber (EEC). Female subjects of non-childbearing potential must be amenorrheic for at least two years or have undergone surgical sterilization (i.e. tubal ligation/occlusion, hysterectomy and/or bilateral oophorectomy).
• At the end of the 4 hour Qualification Phase, the subject's Total Nasal Symptom Score (TNSS) via Electronic Patient Data Acquisition Tablet (ePDAT) must be ≥6 out of a possible of 12 at least twice, with at least one occurring during the last 2 time points to qualify to receive study intervention.
• During Treatment Phases Treatment 1 (T1) and Treatment 2 (T2), subjects are exposed to pollen in EEC for a two hour induction phase. At the end of the two hour symptom induction phase during T1 and T2, subjects meet a minimum threshold total nasal symptom score (TNSS) response of ≥6 out of a possible of 12 at least twice, with at least one occurring during the last 2 time points to qualify to receive study intervention.

Exclusion Criteria:

• Any significant medical condition which, in the judgment of the investigator, is a contraindication to the use of intranasal azelastine hydrochloride (HCl), or might interfere with the trial.
• Subjects with a pre-EEC TNSS ˃3 at T1.
• Subjects with a known allergy to azelastine HCl or any of its inactive ingredients, or with a known contraindication to the use of epinephrine.
• Subjects with a known history of non-allergic rhinitis.
• Subjects with a suspected or known history of anaphylaxis to ragweed allergen.
• Subjects with a suspected or known history of rhinitis medicamentosa.
• In the judgment of the investigator, any respiratory illness or active local infection (e.g., sinusitis) prior to the Qualification Phase that can interfere with the conduct of the study.
• Subjects with a known history of coronary heart disease, ischemic heart disease , high blood pressure, symptomatic prostatic hypertrophy, hepatic insufficienHas a history of immunological disease or malignancy within the past 5 years, with the exception of non-melanoma skin cancer or renal disease.
• Evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular (including hypertension), hepatic, psychiatric, neurologic diseases, or malignancies within the last 5 years.
• Self-reported medical history of tuberculosis, hepatitis or human immunodeficiency virus (HIV).
• Alcoholism or drug abuse within 2 years prior to the Screening Visit or routine consumption of 3 or more alcohol containing beverages per day; Alcohol containing beverages are defined as one beer (5%), one glass of wine (11%) and one shot (40%) hard liquor.
• Self-reported current heavy smokers (>1 pack/25 cigarettes per day).