Efficacy and Safety of On-demand and Continuous Administration of Nasal Spray in the Treatment of Allergic Rhinitis

• Status: Not yet recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

Summary

WHO recommend to divide AR into 4 subgroups according to the symptom frequency (intermittent or persistent) and severity (mild or moderate-to-severe). For the persistent moderate-to-severe AR subgroup, the guideline suggests to treat with intranasal corticosteroid (INS) plus antihistamines (AH1) for 2-4 weeks. If the symptom is controlled then degrade the treatment (usually with INS) and maintenance for more than 4 weeks. However, up to 70% of patients suffering from AR do not follow treatment recommendation, they stopped medication when they feel better. This behavior always leads to uncontrolled AR, which has been identified as a high-risk factor of induction and exacerbation of asthma and chronic rhinosinusitis. A recent survey showed that AR patients prefer to an on-demand treatment rather than continuous treatment. In general, poor adherence is always a considerable issue for all long-term treatments. Previous studies have shown that as dosing frequency increases, the adherence rate decreases. Thus, less medication frequency is an important factor to optimize the management of chronic diseases including AR.

Intranasal AH1 can relieve AR symptoms including sneezing, rhinorrhea and nasal itching in 3 to 5 minutes, while INS can inhibit the underlying mucous allergic inflammation and is recommended as the first-line medication for moderate-to-severe AR. INS combined AH1 have shown a synergic effect on control AR inflammation and provide rapid AR symptom relief. Investigators hypothesis that the on-demand administration of INS combined AH1 can achieve similar AR control level with less dosing frequency as compared to the daily INS maintenance in controlled moderate-to-severe AR patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zheng Liu ENT
• Collaborators: The People's Hospital of Hebei Province; Wuhan Union Hospital, China; Zhongnan Hospital
• Treatments: Azelastine; Fluticasone; Xhance

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).