Phase 4Completed

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

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

Sponsor
Zheng Liu ENT (Academic or other)
Enrollment
182 enrolled
Conditions
Allergic Rhinitis
Interventions
Fluticasone Nasal 50 Mcg/Inh Nasal Spray, Azelastine Nasal 140 Mcg/Inh Nasal Spray; Fluticasone Nasal 50 Mcg/Inh Nasal Spray
Ages
adults, older adults
Registry
NCT05080322

Full record on ClinicalTrials.gov

From the registry

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…

Primary outcomes

  • AR control level after 4-week treatment among the three groups with different treatment

History

  1. Last registry update

  2. Primary completion

  3. Registered

  4. Started