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

Who is this study for? Patients with Allergic Rhinitis
What treatments are being studied? Nasal Spray
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Tongji Hosptial affiliated to Tongji Medical college of Huazhong University of Science and Technology
RECRUITING
Wuhan
Contact Information
Primary
Rongfei Zhu, sub-I
zrf13092@163.com
18986292602
Backup
Zheng Liu, PI
zhengliuent@hotmail.com
18607110505
Time Frame
Start Date: 2021-09-09
Estimated Completion Date: 2025-01-01
Participants
Target number of participants: 150
Treatments
Experimental: on-demand intranasal corticosteroid (INS) plus antihistamines (AH1)
the patients will be treated with on-demand intra-nasal corticosteroid (INS) plus antihistamines (AH1) for 4 weeks
Experimental: on-demand intranasal corticosteroid (INS)
the patients will be treated with on-demand intra-nasal corticosteroid (INS) for 4 weeks
Active_comparator: maintenance intranasal corticosteroid (INS)
the patients will be treated with intra-nasal corticosteroid(INS) maintenance therapy for 4 weeks
Related Therapeutic Areas
Sponsors
Collaborators: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The People's Hospital of Hebei Province, Zhongnan Hospital
Leads: Zheng Liu ENT

This content was sourced from clinicaltrials.gov

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