Treatment of allergic rhinitis with nasal spray options
A Randomized, Open-labeled, Multicenter Clinical Trial to Compare the Efficacy and Safety of On-demand and Continuous Administration of Nasal Spray in the Treatment of Moderate-to-severe Persistent Allergic Rhinitis
This study is testing whether using nasal sprays on-demand or continuously can help people with allergic rhinitis who are sensitive to house dust mites feel better and stick to their treatment plan.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT05080322 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of both on-demand and continuous administration of nasal sprays for patients suffering from allergic rhinitis (AR). The study focuses on individuals who are mono-sensitized to house dust mites and have moderate-to-severe symptoms. Participants will receive either fluticasone or azelastine nasal sprays, with the aim of improving adherence to treatment and controlling AR symptoms. The trial is designed to address the common issue of poor treatment adherence among AR patients, which can lead to exacerbations of asthma and chronic rhinosinusitis.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 who have been diagnosed with allergic rhinitis and are sensitized to house dust mites.
Not a fit: Patients with severe nasal conditions, recent upper respiratory infections, or those who have undergone specific therapies in the past may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment regimen for allergic rhinitis, improving patient adherence and quality of life.
How similar studies have performed: Previous studies have shown success with similar approaches in improving adherence to treatment for allergic rhinitis, making this study a continuation of established research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-65 years old * AR patients (according to ARIA guidelines) * Mono-sensitized to HDM and had AR symptoms after HDM exposure; * Participants had at least 2 nasal symptoms(sneezing, runny nose, itching, nasal congestion) in the screening period * ARCT score ≥20 after 2-week INS combined with AH1 treatment at run-in period * had adequent informed and given their consent to participate in the study. Exclusion Criteria: * Pregnant or lactating women, patients with malignant tumor, patients with congenital or acquired immunodeficiency disease, patients with mental illness * Acute upper respiratory infection in the run-in period * History of chronic sinusitis with nasal polyps * Severe deviation of nasal septum * received allergen immunotherapy in the past 5 years * received biological therapy in the past 6 months * Acute upper respiratory tract infection in run-in period * Patients who failed to achieve AR control in the run-in period * Patients who are participating in other clinical trials * patients who are not suitable for this clinical trial due to other reasons (evaluated by investigators).
Where this trial is running
Wuhan, Hubei
- Tongji Hosptial affiliated to Tongji Medical college of Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Rongfei Zhu, sub-I
- Email: zrf13092@163.com
- Phone: 18986292602
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.