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Compare Captisol-Enabled (CE) Budesonide + Azelastine Nasal Solution and Rhinocort Aqua + Astelin in an Environmental Exposure Chamber (EEC) Study of Allergic Rhinitis

Information source: Ligand Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Seasonal Allergic Rhinitis

Intervention: Budesonide + Azelastine (Drug); Budesonide + Azelastine (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Ligand Pharmaceuticals

Official(s) and/or principal investigator(s):
Deepen Patel, MD, Principal Investigator, Affiliation: Allied Research International - Cetero Research


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.

Clinical Details

Official title: A Randomized, Double-Blind, Placebo-Controlled, 3-Way Cross-Over Study Comparing Relative Efficacy of CE Budesonide+Azelastine & Rhinocort Aqua+Astelin Nasal Sprays Against Placebo in the Treatment of AR in an EEC Model

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Patient-rated Total Nasal Symptom Score

Secondary outcome:

Patient-rated Total Symptom Score

Patient-rated EEC-RQLQ assessment


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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


- 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


- 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


- 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

Locations and Contacts

Allied Research International - Cetero Research, Mississauga, Ontario L4W 1N2, Canada
Additional Information

Starting date: February 2008
Last updated: October 2, 2012

Page last updated: August 23, 2015

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