The goal of this clinical trial is to learn about the clinical efficacy and safety of ganciclovir (GCV) capsules in the treatment of refractory moderate-to-severe allergic rhinitis. The main questions it aims to answer are:
1. Whether ganciclovir improve nasal symptoms and life quality in patients with refractory moderate-to-severe allergic rhinitis. 2. Whether ganciclovir is safe for the treatment of allergic rhinitis.
Participants with refractory moderate-to-severe allergic rhinitis will be included in the trial based on the inclusion and exclusion criteria, and randomized into experimental and control groups.
The two groups will be treated with blinded ganciclovir capsules or placebo for two weeks, with the background therapy of mometasone furoate aqueous nasal spray. A placebo is a look-alike capsule that contains no active drug. Nasal symptom scores, nasal secretions, blood samples and adverse events will be collected during the visits.
Researchers will compare the experimental and control groups to see whether ganciclovir improve symptoms and is safe for the treatment of refractory moderate-to-severe allergic rhinitis.
Aged between 18 and 65 years.
Diagnosed with moderate-to-severe perennial allergic rhinitis based on Chinese guideline for diagnosis and treatment of allergic rhinitis (2022, revision) with Allergic Rhinitis Control Test (ARCT) score <20.
Total Nasal Symptom Score (TNSS) ≥6 or at least two of the four subdomains(sneezing, rhinorrhea, nasal itching, and nasal obstruction) ≥2 at the time of both screening and randomization. And the improvement in TNSS was assessed as < 30% at randomization compared to screening.
The participant is allergic to dust mites or other perennial allergens
Participants with hypersensitivity to ganciclovir capsules and its excipients.
Have symptoms of viral infection, fever and other systemic symptoms in the past 2 weeks.
Pregnant or lactating women and participants who have pregnancy plan during the study period.
Participants with severe neutropenia (absolute neutrophil count less than 0.5*10^9/L) or severe thrombocytopenia (platelet count less than 2.5*10^10/L).
Parallel
Ganciclovir Oral Capsule
Drug2-week treatment phase：Ganciclovir capsules(250mg), take 2 capsules twice a day
Ganciclovir Simulant Oral Capsule
Drug2-week treatment phase：Ganciclovir simulant capsules(0mg), take 2 capsules twice a day
Mometasone Nasal
DrugFrom screening phase to follow-up phase：Mometasone furoate aqueous nasal spray(50μg/spray), take 1 spray once a day
Rate of improvement in TNSS scores
After 2 weeks of treatment phase, the investigator assess the rate of change in the difference in TNSS from baseline. Calculated as (total post-treatment symptom score - total pre-treatment symptom score)/total pre-treatment symptom score × 100%.
Total effective rate
Participants with a \>30% decrease in total nasal symptom scores (TNSS) after 2 weeks of treatment are considered effective. The percentage of participants effective on treatment will be assessed as total effective rate.
Rate and absolute value of change in TNSS and four subdomains.
TNSS assesses symptom severity in four subdomains consisting of sneezing, rhinorrhea, nasal itching, and nasal obstruction. Each subdomain is rated on a scale of 0 (no symptoms) to 3 (severe symptoms that are difficult to tolerate and interfere with daily activity). The overall TNSS score is the sum of all four symptoms resulting in a maximum score of 12. After the treatment phase, evaluate the rate and absolute value of change in TNSS and four subdomains from baseline.
Rate and absolute value of change in visual analogue scale (VAS) scores.
The VAS ranges from 0 to 100. A score of 0 corresponds to no symptoms and 100 corresponds to the worst symptoms. After the treatment phase, evaluate the rate and absolute value of change in VAS scores from baseline.
Rate and absolute value of change in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
RQLQ is a validated QOL instrument consisting of 28 questions in seven domains (limited activity, sleep, practical problems, nasal symptoms, eye symptoms, emotional function, and non-nose/eye or other symptoms). Each domain is graded from zero (not impaired at all) to six (severely impaired), and the overall RQLQ is the mean score of all 28 responses. After the treatment phase, evaluate the rate and absolute value of change in RQLQ scores from baseline.
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