Using ganciclovir capsules to treat severe allergic rhinitis

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

This study is testing if ganciclovir capsules can help people with severe allergic rhinitis feel better and improve their quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (Academic / other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06436534 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of ganciclovir capsules in patients suffering from refractory moderate-to-severe allergic rhinitis. Participants will be randomly assigned to receive either ganciclovir or a placebo for two weeks, alongside a nasal spray treatment. The study will assess improvements in nasal symptoms and quality of life, as well as monitor for any adverse effects. Various tests will be conducted to ensure participants meet the necessary criteria for inclusion in the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with moderate-to-severe perennial allergic rhinitis that has not improved with standard treatments.

Not a fit: Patients with hypersensitivity to ganciclovir or those experiencing acute viral infections will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients with severe allergic rhinitis who have not responded to other therapies.

How similar studies have performed: Previous clinical observations have indicated that ganciclovir may effectively treat refractory allergic rhinitis, suggesting potential success for this trial.

Eligibility criteria

Inclusion Criteria:

1. Aged between 18 and 65 years.
2. 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.
3. 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.
4. The participant is allergic to dust mites or other perennial allergens
5. Voluntarily participate in the clinical trial and sign the informed consent.

Exclusion Criteria:

1. Participants with hypersensitivity to ganciclovir capsules and its excipients.
2. Have symptoms of viral infection, fever and other systemic symptoms in the past 2 weeks.
3. Pregnant or lactating women and participants who have pregnancy plan during the study period.
4. 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).
5. Comorbidities such as upper and lower respiratory tract infections, history of acute or chronic sinusitis, dry rhinitis, atrophic rhinitis, severe deviated septum and asthma.
6. Participants with other severe heart, lung, liver and kidney disease.
7. Participants who had received any live or attenuated vaccine within 4 weeks prior to baseline or intended to receive live or attenuated vaccine (or BCG treatment) during the study period or within 4 weeks after the last administration of the investigational drug product.
8. Participants with a history of HIV infection or who test positive for HIV serology.
9. Participants currently infected or chronically infected with hepatitis B virus (HBV) or hepatitis C virus (HCV).
10. Participants with cirrhosis and/or chronic hepatitis.
11. Participants who have been diagnosed with active parasitic infections or are at high risk of developing such infections.。
12. Participants with a known or suspected history of immunosuppression, including a history of invasive opportunistic infections (e.g., histoplasmosis, listeriosis, coccidioidomycosis, pneumosporidiosis, aspergillosis). Or participants with what researchers believe to be unusually frequent, recurring, or prolonged infections.
13. Participants with a known history of malignancy within 5 years prior to screening.
14. Participants with severe co-morbidities that, in the opinion of the investigator, would adversely affect their participation in this study.
15. Participants with combined neurological or psychiatric disorders who are unable or reluctant to cooperate.
16. Participants with disabilities prescribed by law (blind, deaf, mute, mentally challenged, mentally handicapped, etc.).
17. Participants suspected or having a history of alcohol and drug abuse.
18. Other participants who have been involved in other clinical trials within 3 months before the screening.
19. The researchers consider it inappropriate to participate in this clinical trial.

Where this trial is running

Wuhan, Hubei

• Wuhan Union Hospital — Wuhan, Hubei, China (Recruiting)

Study contacts

• Principal investigator: Jianjun Chen — Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
• Study coordinator: Jianjun Chen

Conditions Rhinitis, Allergic