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

NCT05080322 | Recruiting Phase 4 DMC

• 1 other identifier: AR-DEM-2021
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

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

  The efficacy and safety of on-demand INS (Fluticasone) combined with nasal spray AH1(Azelastine), on-demand INS and INS maintenance therapy were evaluated and compared by recording the daily symptom score and adverse events. The primary endpoint is the AR control level after 4-week treatment.

  6 months

Secondary Outcomes (1)

• AR recurrence time after 4-week treatment

  6 months

Study Arms (3)

on-demand intranasal corticosteroid (INS) plus antihistamines (AH1)

EXPERIMENTAL

the patients will be treated with on-demand intra-nasal corticosteroid (INS) plus antihistamines (AH1) for 4 weeks

Drug: Fluticasone Nasal 50 Mcg/Inh Nasal Spray, Azelastine Nasal 140 Mcg/Inh Nasal Spray

on-demand intranasal corticosteroid (INS)

EXPERIMENTAL

the patients will be treated with on-demand intra-nasal corticosteroid (INS) for 4 weeks

Drug: Fluticasone Nasal 50 Mcg/Inh Nasal Spray

maintenance intranasal corticosteroid (INS)

ACTIVE COMPARATOR

the patients will be treated with intra-nasal corticosteroid(INS) maintenance therapy for 4 weeks

Drug: Fluticasone Nasal 50 Mcg/Inh Nasal Spray

Interventions

Fluticasone Nasal 50 Mcg/Inh Nasal Spray, Azelastine Nasal 140 Mcg/Inh Nasal Spray DRUG

on-demand INS (Fluticasone) combined with nasal spray AH1(Azelastine)

Also known as: Flixonase,H20140117, AZEP,H20150201

on-demand intranasal corticosteroid (INS) plus antihistamines (AH1)

Fluticasone Nasal 50 Mcg/Inh Nasal Spray DRUG

on-demand or maintenance

Also known as: Flixonase,H20140117

maintenance intranasal corticosteroid (INS); on-demand intranasal corticosteroid (INS)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Zheng Liu ENT: lead
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Zhongnan Hospital: collaborator
• The People's Hospital of Hebei Province: collaborator

Study Sites (1)

Tongji Hosptial affiliated to Tongji Medical college of Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (17)

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MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Zheng Liu, PI

  Tongji Hospital

  STUDY DIRECTOR

Central Study Contacts

Rongfei Zhu, sub-I

CONTACT

18986292602; zrf13092@163.com

Zheng Liu, PI

CONTACT

18607110505; zhengliuent@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: October 15, 2021
• Study Start: September 9, 2021
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: The Clinical Study Report (CSR) will be available in six months and for 1 year.
• Access Criteria: The peer investigators who contact with the Central Contact Person by email or phone call.

Locations

CN (1)