The primary objective of this study was to compare Placebo to Captisol-Enabled Budesonide +
Azelastine in a single spray and two separate sprays (Budesonide + Azelastine) in patients
with Seasonal Allergic Rhinitis exposed to controlled ragweed pollen.
Inclusion Criteria:
- Patients must have a clinical history of SAR
- Adults (males and females) aged 18 to 65
- Patients must have documentation of a positive skin test within 12 months of
screening to ragweed allergen defined by a positive case history and a positive skin
prick and/or intradermal test for ragweed allergen.
- Non-pregnant, non-lactating females, or women who are post-menopausal or are
naturally or surgically sterile
- Females of childbearing potential must have a confirmed absence of pregnancy
according to a negative urine pregnancy test and must be using acceptable birth
control methods
- In generally good health on the basis of medical history and physical examination.
- Willingness to attend all study visits.
- Capable of following and understanding instructions.
- Willing and able to provide written informed consent prior to initiation of any study
procedures, including initiation of washout of any concomitant medications
Exclusion Criteria:
- Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for
in-vitro fertilization
- Have clinically significant physical findings of nasal anatomical deformities causing
greater than 50% obstruction based on the clinical estimate of the investigator,
including nasal polyps, septal defects or other clinically significant respiratory
tract malformations, recent nasal biopsy, nasal trauma, or surgery and atrophic
rhinitis or rhinitis medicamentosa
- Previous participation in a budesonide study within 1 month prior to the Screening
Visit.
- Currently participating in a clinical trial or has been exposed to an investigational
treatment within the 30 days prior to the Screening Visit.
- A known hypersensitivity to any corticosteroid or any of the excipients in the
formulation of the investigational drug (e. g., any adverse experience with
budesonide, azelastine or the Captisol-containing products Vfend IV or Geodon IM).
- History of severe respiratory infection or disorder
- History of alcohol or drug abuse
- History of a positive test for HIV, hepatitis B or hepatitis C.
- Use of any of the prohibited medications within the identified exclusion periods
- Use of antibiotic therapy for acute conditions
- Initiation of immunotherapy or dose escalation during the study period.
- Non-vaccinated exposure to or active infection with chickenpox or measles within the
21 days preceding the Screening Visit.
- Exposure to systemic corticosteroids
- Use of topical corticosteroids in concentrations in excess of 1% hydrocortisone or
equivalent
- History of epilepsy or seizures
- History of coronary heart disease, uncontrolled hypertension, or other clinically
significant cardiovascular disease.
- Have any of the following conditions that are judged by the investigator to be
clinically significant and/or affect the patient's ability to participate in the
clinical trial:
- Impaired hepatic function including alcohol related liver disease or cirrhosis
- History of ocular disturbances (e. g., glaucoma or posterior subcapsular
cataracts)
- Any systemic infection
- Hematological, renal, endocrine (except for controlled diabetes mellitis or
postmenopausal symptoms or hypothyroidism)
- Gastrointestinal disease
- Malignancy (excluding basal cell carcinoma)
- A current neuropsychiatric condition with or without drug therapy
