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Ridsetest

Evaluation of the Efficacy and Safety of DEF-9012 in Adults with Chronic Allergic Rhinitis

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of DEF-9012 in Adults with Chronic Allergic Rhinitis

Trial Locations

Multiple centers across the United States

Background

Chronic allergic rhinitis (CAR) is a persistent condition characterized by nasal congestion, sneezing, itching, and rhinorrhea due to allergen exposure. It significantly impacts the quality of life and productivity. This trial aims to evaluate the efficacy and safety of DEF-9012, an investigational antihistamine and anti-inflammatory drug.

Objectives

  1. Primary Objective: To assess the efficacy of DEF-9012 in reducing nasal symptom severity in adults with chronic allergic rhinitis.

  2. Secondary Objectives:

    • To evaluate the impact of DEF-9012 on eye symptoms (itching, redness).

    • To assess the improvement in quality of life related to allergic symptoms.

    • To evaluate the safety and tolerability of DEF-9012.

Study Design

  • Type: Randomized, double-blind, placebo-controlled

  • Estimated Enrollment: 400 participants

  • Allocation: 1:1 ratio to either DEF-9012 or placebo

  • Intervention Model: Parallel assignment

  • Masking: Double (participant and investigator)

  • Primary Purpose: Treatment

Inclusion Criteria

  • Adults aged 18-65 years

  • Documented history of chronic allergic rhinitis for at least 12 months

  • Positive skin prick test or specific IgE test for relevant allergens

  • Moderate to severe nasal symptoms despite the use of standard treatments

  • Ability to understand and sign the informed consent form

Exclusion Criteria

  • Current participation in another clinical trial

  • Known hypersensitivity to DEF-9012 or its components

  • Significant underlying health conditions that may interfere with study outcomes (e.g., severe asthma, uncontrolled diabetes)

  • Pregnant or breastfeeding women

Interventions

  • Experimental Group: DEF-9012, oral administration, dosage as per protocol

  • Control Group: Placebo, oral administration, matched in appearance to DEF-9012

Outcome Measures

  • Primary Outcome Measure: Change in Total Nasal Symptom Score (TNSS) from baseline to 8 weeks.

  • Secondary Outcome Measures:

    • Change in Total Ocular Symptom Score (TOSS) from baseline to 8 weeks.

    • Improvement in quality of life from baseline to 8 weeks, evaluated using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).

    • Incidence of adverse events throughout the study duration.

Study Timeline

  • Estimated Start Date: August 1, 2024

  • Estimated Primary Completion Date: December 31, 2025

  • Estimated Study Completion Date: June 30, 2026

Safety Monitoring

An independent Data Safety Monitoring Board (DSMB) will oversee the trial's safety data and recommend continuation, modification, or termination of the study based on predefined criteria.

Statistical Analysis

  • Primary Efficacy Analysis: Comparison of the change in TNSS between the DEF-9012 and placebo groups using mixed-effects models for repeated measures (MMRM).

  • Secondary Analyses: Similar models for TOSS and RQLQ scores, along with descriptive statistics for safety outcomes.

 

Contact Information

For more information, potential participants or referring physicians can contact the study coordinator at:

Conclusion

This clinical trial aims to address the need for effective treatments for chronic allergic rhinitis by evaluating the potential benefits and safety of DEF-9012. The results of this study could provide significant insights into the management of chronic allergic rhinitis and improve the quality of life for affected individuals.

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