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

October 2, 2012 updated by: Ligand Pharmaceuticals

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
nasal spray, one spray per nostril from each of 2 bottles at time 0
Other Names:
  • phosphate buffered saline solution
Experimental: Captisol-Enabled Budesonide + Azelastine
Drug: Budesonide + Azelastine
nasal spray, one spray per nostril at time 0 plus one spray Placebo
Other Names:
  • CDX-313
  • Captisol
Drug: Budesonide + Azelastine
nasal spray, one spray of each per nostril at time 0
Other Names:
  • Rhinocort Aqua
  • Astelin
Active Comparator: Rhinocort Aqua+Astelin
Drug: Budesonide + Azelastine
nasal spray, one spray per nostril at time 0 plus one spray Placebo
Other Names:
  • CDX-313
  • Captisol
Drug: Budesonide + Azelastine
nasal spray, one spray of each per nostril at time 0
Other Names:
  • Rhinocort Aqua
  • Astelin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Patient-rated Total Nasal Symptom Score
Time Frame: 10 mins, 20 mins, 30 mins, 40 mins, 60 mins, 90 mins, 120 mins and then every hour up to 10 hours post dose
10 mins, 20 mins, 30 mins, 40 mins, 60 mins, 90 mins, 120 mins and then every hour up to 10 hours post dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Patient-rated Total Symptom Score
Time Frame: 10 mins, 20 mins, 30 mins, 40 mins, 60 mins, 90 mins, 120 mins and then every hour up to 10 hours post dose
10 mins, 20 mins, 30 mins, 40 mins, 60 mins, 90 mins, 120 mins and then every hour up to 10 hours post dose
Patient-rated EEC-RQLQ assessment
Time Frame: -0.75 hours, 2 hours, 6 hours and 10 hours post dose
-0.75 hours, 2 hours, 6 hours and 10 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ligand Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Deepen Patel, MD, Allied Research International - Cetero Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 15, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CDX313CT001
  • P2DS07001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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