7 Day Study of Mast Cell Inhibitor, R926112, in Patients With Symptomatic Seasonal Allergic Rhinitis

NCT00115089 | Completed Phase 2

• 1 other identifier: C-926112-005A
• Study Type: interventional
• Target: 375
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a study of the effectiveness and safety of a new nasal spray for the relief of the symptoms of seasonal allergies. The agents being compared are: R926112 (a novel anti-allergy medicine), Beconase (beclomethasone dipropionate, an established FDA approved steroid treatment), and an inactive placebo. The study hypothesis is that R926112 will be superior to placebo at the end of a week of testing and evaluation. The study does not have the power to determine how R926112 compares to Beconase.

Conditions

Rhinitis, Allergic, Seasonal

Keywords

Allergic Rhinitis; Nasal Spray; Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Change in total nasal symptom score from baseline over time

Secondary Outcomes (3)

• Change in individual symptoms

• Global therapeutic response

• Quality of life score

Interventions

R926112 DRUG

Beclomethasone dipropionate DRUG

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must sign a written informed consent form and assent (if applicable) for study participation.
• Males and females, 12 years of age or older
• Subjects must have a history consistent with seasonal allergic rhinitis (SAR) during the fall pollen season for at least the previous 2 years.
• Subjects must be skin test positive to a relevant fall aeroallergen within the past 12 months with at least a moderate reaction as defined by at least a 5 mm wheal.
• Nasal exam to exclude significant swelling, bleeding, crusting, or polyps
• Subjects receiving immunotherapy must be on a stable maintenance regimen for at least 30 days before screening. Adjustments to the regimen following a brief period of missed injections or the normal reduction in dose due to a vaccine refill does not preclude participation.
• Female subjects of childbearing potential must have negative urine tests for pregnancy at Visits 1 and 2.
• Female subjects of childbearing potential who are sexually active will be expected to use a medically recognized birth control method throughout the study: systemic contraceptive (oral, implant, injection, patch), diaphragm with intravaginal spermicide, cervical cap, vaginal ring, intrauterine device, or condom with spermicide. Females who are not sexually active will be admitted by the discretion of the Investigator. Acceptable birth control will be documented in the subject's case report form.
• Subjects must be willing to adhere to dosing schedules, study visits, and study requirements.

You may not qualify if:

• Clinically significant medical conditions (such as hepatic, neurological, hematological, renal, cardiac, gastrointestinal, endocrine, or other major systemic disease), which in the judgment of the Investigator, might interfere with the study, require treatment or make implementation of the protocol or interpretation of the study results difficult.
• Clinically relevant abnormalities in laboratory results or electrocardiogram (ECG) as determined by the investigator
• Asthma that requires treatment other than with inhaled, short acting beta agonist alone.
• Female subjects who are pregnant, trying to become pregnant, or nursing.
• Nasal structural abnormalities, including large nasal polyps or marked septal deviation that significantly interfere with nasal airflow or nasal surgery within the past year.
• Upper respiratory infection within 3 weeks before the date of Randomization/Visit 2.
• Treatment with any investigational drug in the last 30 days before the date of Randomization/Visit 2.
• History of drug or alcohol abuse that according to the Investigator could interfere with the study.
• Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
• Subjects unlikely to comply with study procedures, unable to return for study visits, or unlikely to complete the study, or expecting or planning to travel outside the area of the prevalent aeroallergen during the study period.
• History of hypersensitivity to steroids or to the excipients.
• Use of tricyclic antidepressants within the past 30 days prior to date of Randomization/Visit 2.
• Ocular herpes simplex or cataracts present at the time of Screening Visit.

Sponsors & Collaborators

• Rigel Pharmaceuticals: lead

Related Publications (1)

• Meltzer EO, Berkowitz RB, Grossbard EB. An intranasal Syk-kinase inhibitor (R112) improves the symptoms of seasonal allergic rhinitis in a park environment. J Allergy Clin Immunol. 2005 Apr;115(4):791-6. doi: 10.1016/j.jaci.2005.01.040.

  PMID: 15806000 BACKGROUND

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; Rhinitis, Allergic

Interventions

Beclomethasone

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated

Study Officials

• Elliott Grossbard, M.D.

  Rigel Pharmaceuticals

  STUDY DIRECTOR

• Eli Meltzer, M.D.

  Allergy and Asthma Medical Group and Research Center, San Diego

  PRINCIPAL INVESTIGATOR

• Harold Nelson, M.D.

  National Jewish Medical Research Center, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 20, 2005
• First Posted: June 21, 2005
• Study Start: July 1, 2005
• Study Completion: September 1, 2005
• Last Updated: November 11, 2005

Record last verified: 2005-11