A Randomized, Double-blind, Placebo-controlled, Single-center Clinical Trial of Ganciclovir Capsules in the Treatment of Refractory Moderate-to-severe Allergic Rhinitis

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

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

• Voluntarily participate in the clinical trial and sign the informed consent.

Locations
Other Locations
China
Wuhan Union Hospital
RECRUITING
Wuhan
Contact Information
Primary
Jianjun Chen
ylly80331@163.com
+86-13659851719
Time Frame
Start Date: 2024-05-24
Estimated Completion Date: 2026-05
Participants
Target number of participants: 50
Treatments
Experimental: Ganciclovir
Screening phase(Day -14±2\~0):Mometasone furoate nasal spray(50μg/spray), take 1 spray once a day.~Treatment phase(Day 1\~14±2): Ganciclovir capsules(250mg), take 2 capsules twice a day + Mometasone furoate nasal spray(50μg/spray), take 1 spray once a day.~Follw-up phase(Day 14\~28±2):Mometasone furoate nasal spray(50μg/spray), take 1 spray once a day.
Placebo_comparator: Placebo
Screening phase(Day -14±2\~0):Mometasone furoate nasal spray(50μg/spray), take 1 spray once a day.~Treatment phase(Day 1\~14±2): Ganciclovir simulant capsules(0mg), take 2 capsules twice a day + Mometasone furoate nasal spray(50μg/spray), take 1 spray once a day.~Follw-up phase(Day 14\~28±2):Mometasone furoate nasal spray(50μg/spray), take 1 spray once a day.
Related Therapeutic Areas
Sponsors
Leads: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

This content was sourced from clinicaltrials.gov