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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT00940953•Ligand Pharmaceuticals

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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
+14 more criteria

Locations (1)

Allied Research International - Cetero Research

Mississauga, Ontario, Canada

Key Dates

Start Date

February 1, 2008

Primary Completion Date

May 1, 2008

Completion Date

May 1, 2008

Last Updated

October 4, 2012

Enrollment

108

ACTUAL participants

Conditions

Seasonal Allergic Rhinitis

Interventions

Budesonide + Azelastine

DRUG

Budesonide + Azelastine

DRUG

Placebo

DRUG

A Study to Assess the Efficacy and Safety of PG-011 Nasal Spray in Adults With Moderate to Severe Seasonal Allergic Rhinitis

NCT06837233

Seasonal Allergic Rhinitis

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NCT03570957

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Efficacy and Safety of PQ Grass in Subjects With Seasonal Allergic Rhinitis and/or Rhinoconjunctivitis Induced by Grass Pollen

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 4, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Efficacy and Safety of PG-011 Nasal Spray in Adults With Moderate to Severe Seasonal Allergic Rhinitis

A Clinical Pharmacology Study of MT-2990 in Seasonal Allergic Rhinitis Patients

Efficacy and Safety of PQ Grass in Subjects With Seasonal Allergic Rhinitis and/or Rhinoconjunctivitis Induced by Grass Pollen

Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Seasonal Allergic Rhinitis (MK-4117-204)

To Investigate Drug-drug Interaction and Relative Bioavailability Between the FDC AzelastineHCL/Beclomethasone Dipropionate Nasal Spray, & Beclomethasone Dipropionate Nasal Spray in the Test Vehicle, and RinoClenil® Nasal Spray

Efficacy and Safety of Azelastine +Mometasone , Nasal Spray, 140 mcg + 50 mcg, (Sandoz d.d., Slovenia) and Momat Rino Advance, Nasal Spray, 140 mcg + 50 mcg, (Glenmark, India) Administered as a Monotherapy to Patients With Seasonal Allergic Rhinitis.