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Rhinitis, AllergicNCT06436534

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

A study testing Ganciclovir Oral Capsule, Ganciclovir Simulant Oral Capsule and Mometasone Nasal in people with Rhinitis, Allergic, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Rhinitis, Allergic
What is being tested?
Ganciclovir Oral Capsule, Ganciclovir Simulant Oral Capsule and Mometasone Nasal
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteChina
Study dates
24 May 2024to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.
  • Participants with disabilities prescribed by law (blind, deaf, mute, mentally challenged, mentally handicapped, etc.).
  • Participants suspected or having a history of alcohol and drug abuse.
  • Other participants who have been involved in other clinical trials within 3 months before the screening.
  • The researchers consider it inappropriate to participate in this clinical trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • Wuhan Union Hospital

    Wuhan, Hubei, 430022

    Jianjun Chen, +86-13659851719, ylly80331@163.com

    Recruiting

Other trials in China

About this study

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

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.
Read more

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.

Read the detailed description

Ganciclovir (GCV) is clinically used for the treatment of DNA viral infections. In clinical practice, we have found that patients with refractory AR have improved nasal symptoms after oral administration of ganciclovir. In clinical practice, we have found that patients with refractory AR have improved nasal symptoms after oral administration of ganciclovir. To further explore the role of GCV in the treatment of refractory allergic rhinitis, we have conducted an interventional non-randomised cohort study of GCV for refractory AR. The results found that 65% of all refractory AR patients included in the observation were effectively treated with GCV. Based on the previous discovery in the clinical practice, the conjecture is proposed that ganciclovir may improve symptoms in allergic rhinitis patients, in particular the patients with refractory moderate-to-severe allergic rhinitis. Thus, the randomized, double-blind, placebo-controlled clinical trial was designed to explore the validity of this hypothesis.

The research involves three phases: screening phase(Day-14±2~0);baseline (Day1);treatment phase (Day1~14);follow-up phase (Day14~28).

In the screening phase, anterior rhinoscopy, serum specific IgE test, skin prick test, total nasal symptom scores (TNSS), visual analogue scale (VAS) scores, Allergic Rhinitis Control Test (ARCT) score will be performed for participants. Participants who meet the inclusion and exclusion criteria will enter the treatment phase and receive the medication for two weeks. At the end of the treatment, researchers will follow participants for two weeks to track efficacy and safety.

Researchers will collect participants' symptom scores, nasal secretions and blood. The biological specimens will be used to test for indicators that support the determination of therapeutic efficacy. Vital signs, blood routine examination, urine routines, liver function test, kidney function test and electrocardiograms will be measured for participants before and after treatment to assess the safety of ganciclovir.

The data collected will be statistically analyzed to examine the clinical efficacy and safety of ganciclovir capsules in the treatment of refractory moderate-to-severe allergic rhinitis.

Being tested
Ganciclovir Oral Capsule, Ganciclovir Simulant Oral Capsule, Mometasone Nasal
Medical subject headings
Rhinitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ganciclovir Oral CapsuleDrug

    Also called Ganciclovir

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

  • Ganciclovir Simulant Oral CapsuleDrug

    Also called Ganciclovir

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

  • Mometasone NasalDrug

    Also called Mometasone furoate aqueous nasal spray, NASONEX, Mometasone furoate nasal spray

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

Study groups in NCT06436534
Study groupRoleWhat they receive
GanciclovirExperimentalScreening 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.
Receives: Drug: Ganciclovir Oral Capsule; Drug: Mometasone Nasal
PlaceboPlacebo comparatorScreening 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.
Receives: Drug: Ganciclovir Simulant Oral Capsule; Drug: Mometasone Nasal

What is being measured

The primary outcome is the main question the study is designed to answer.

  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%.

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

Secondary outcomes (6)
  1. 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.

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

  2. 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.

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

  3. 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.

    Measured: From baseline to the end of treatment (2 weeks)

  4. 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.

    Measured: From baseline to the end of treatment (2 weeks)

  5. Change in mean TNSS during a 2-week administration period

    Participants assess the TNSS score on a daily basis. 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 change in mean TNSS during a 2-week administration period from baseline.

    Measured: During the 2-week administration period

  6. Rate and absolute value of change in TNSSand four subdomains, VAS, RQLQ scores in follow-up phase

    After the follow-up phase, evaluate the rate and absolute value of change in TNSS, VAS, RQLQ scores from baseline.

    Measured: From baseline to the end of follow-up phase (4 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2024
  2. Study start24 May 2024
  3. Primary completionOct 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06436534
Sponsor's protocol ID
ENTAR-GCV20240205
Status last verified
Jul 2026
First submitted
24 May 2024
Last updated
13 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29268096
  • 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.

    PubMed 24493798
  • Crumpacker CS. Ganciclovir. N Engl J Med. 1996 Sep 5;335(10):721-9. doi: 10.1056/NEJM199609053351007. No abstract available.

    PubMed 8786764
  • 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.

    PubMed 23419058
  • 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.

    PubMed 21518040

Questions about this trial

What is this clinical trial studying?

A study testing Ganciclovir Oral Capsule, Ganciclovir Simulant Oral Capsule and Mometasone Nasal in people with Rhinitis, Allergic, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jianjun Chen (+86-13659851719, ylly80331@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of improvement in TNSS scores (time frame: From baseline to the end of treatment phase(2 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06436534, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.

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