Efficacy and Safety of Ganciclovir Capsules in the Treatment of Refractory Moderate-to-severe Allergic Rhinitis

NCT06436534 | Recruiting

• 1 other identifier: ENTAR-GCV20240205
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 1.Whether ganciclovir improve nasal symptoms and life quality in patients with refractory moderate-to-severe allergic rhinitis.
2. 2.Whether ganciclovir is safe for the treatment of allergic rhinitis.

Conditions

Rhinitis, Allergic

Outcome Measures

Primary Outcomes (1)

• 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%.

  From baseline to the end of treatment phase(2 weeks)

Secondary Outcomes (6)

• Total effective rate

  From baseline to the end of treatment phase(2 weeks)

• Rate and absolute value of change in TNSS and four subdomains.

  From baseline to the end of treatment phase(2 weeks)

• Rate and absolute value of change in visual analogue scale (VAS) scores.

  From baseline to the end of treatment (2 weeks)

• Rate and absolute value of change in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)

  From baseline to the end of treatment (2 weeks)

• Change in mean TNSS during a 2-week administration period

  During the 2-week administration period

Study Arms (2)

Ganciclovir

EXPERIMENTAL

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.

Drug: Ganciclovir Oral Capsule; Drug: Mometasone Nasal

Placebo

PLACEBO COMPARATOR

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.

Drug: Ganciclovir Simulant Oral Capsule; Drug: Mometasone Nasal

Interventions

Ganciclovir Oral Capsule DRUG

2-week treatment phase：Ganciclovir capsules(250mg), take 2 capsules twice a day

Also known as: Ganciclovir

Ganciclovir

Ganciclovir Simulant Oral Capsule DRUG

2-week treatment phase：Ganciclovir simulant capsules(0mg), take 2 capsules twice a day

Also known as: Ganciclovir

Placebo

Mometasone Nasal DRUG

From screening phase to follow-up phase：Mometasone furoate aqueous nasal spray(50μg/spray), take 1 spray once a day

Also known as: Mometasone furoate aqueous nasal spray, NASONEX, Mometasone furoate nasal spray

Ganciclovir; Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Comorbidities such as upper and lower respiratory tract infections, history of acute or chronic sinusitis, dry rhinitis, atrophic rhinitis, severe deviated septum and asthma.
• Participants with other severe heart, lung, liver and kidney disease.
• 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.
• Participants with a history of HIV infection or who test positive for HIV serology.
• Participants currently infected or chronically infected with hepatitis B virus (HBV) or hepatitis C virus (HCV).
• Participants with cirrhosis and/or chronic hepatitis.
• Participants who have been diagnosed with active parasitic infections or are at high risk of developing such infections.。
• 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.
• Participants with a known history of malignancy within 5 years prior to screening.
• Participants with severe co-morbidities that, in the opinion of the investigator, would adversely affect their participation in this study.
• Participants with combined neurological or psychiatric disorders who are unable or reluctant to cooperate.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

RECRUITING

Related Publications (5)

• Demoly P, Jankowski R, Chassany O, Bessah Y, Allaert FA. Validation of a self-questionnaire for assessing the control of allergic rhinitis. Clin Exp Allergy. 2011 Jun;41(6):860-8. doi: 10.1111/j.1365-2222.2011.03734.x. Epub 2011 Apr 25.

  PMID: 21518040 BACKGROUND

• Mathur V, Burai R, Vest RT, Bonanno LN, Lehallier B, Zardeneta ME, Mistry KN, Do D, Marsh SE, Abud EM, Blurton-Jones M, Li L, Lashuel HA, Wyss-Coray T. Activation of the STING-Dependent Type I Interferon Response Reduces Microglial Reactivity and Neuroinflammation. Neuron. 2017 Dec 20;96(6):1290-1302.e6. doi: 10.1016/j.neuron.2017.11.032.

  PMID: 29268096 BACKGROUND

• Ding Z, Mathur V, Ho PP, James ML, Lucin KM, Hoehne A, Alabsi H, Gambhir SS, Steinman L, Luo J, Wyss-Coray T. Antiviral drug ganciclovir is a potent inhibitor of microglial proliferation and neuroinflammation. J Exp Med. 2014 Feb 10;211(2):189-98. doi: 10.1084/jem.20120696. Epub 2014 Feb 3.

  PMID: 24493798 BACKGROUND

• Crumpacker CS. Ganciclovir. N Engl J Med. 1996 Sep 5;335(10):721-9. doi: 10.1056/NEJM199609053351007. No abstract available.

  PMID: 8786764 BACKGROUND

• Demoly P, Calderon MA, Casale T, Scadding G, Annesi-Maesano I, Braun JJ, Delaisi B, Haddad T, Malard O, Trebuchon F, Serrano E. Assessment of disease control in allergic rhinitis. Clin Transl Allergy. 2013 Feb 18;3(1):7. doi: 10.1186/2045-7022-3-7.

  PMID: 23419058 BACKGROUND

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Ganciclovir; Mometasone Furoate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Jianjun Chen

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianjun Chen

CONTACT

+86-13659851719; ylly80331@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: May 31, 2024
• Study Start: May 24, 2024
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)