Clinical trial NCT05607446: To Evaluate the Efficacy and Safety of TQC3564 Tablets in the Treatment of Persistent Allergic Rhinitis
Official title: A Single-center, Randomized, Double-blind, Two-cycle, Two-way Crossover Phase Ib Study to Evaluate the Efficacy and Safety of TQC3564 Tablets in the Treatment of Persistent Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Allergic Rhinitis
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-11-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A clinical study to evaluate the efficacy and safety of tqc3564 tablets in the treatment of persistent allergic rhinitis. A total of 24 patients will be enrolled.


Eligibility criteria: Inclusion Criteria:

* Age 18\~65 years old, male or female;
* Meet the clinical diagnostic criteria for allergic rhinitis, and the diagnosis is based on the "Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2015, Tianjin)" issued by the Rhinology Group of the Otolaryngology Head and Neck Surgery Branch of the Chinese Medical Association:

  1. Symptoms: sneezing 2 or more symptoms, such as watery mucus, nasal itching and nasal congestion, persist or accumulate for more than 1 hour per day, and may be accompanied by eye symptoms such as itching, watering and redness;
  2. Signs: Pale and edema of the nasal mucosa is common. Nasal watery secretions;
  3. Allergen test: at least one allergen SPT and/or serum-specific IgE positive (test results within 12 months before screening);
* Female subjects of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; negative serum pregnancy test within 14 days before study enrollment , and must be non-lactating subjects; male subjects should agree to use contraception during the study period and for 6 months after the end of the study period.
* The subjects voluntarily joined the study, signed the informed consent, and had good compliance.

Exclusion Criteria:

* Patients with non-allergic rhinitis, such as drug-induced rhinitis, vasomotor rhinitis, non-allergic rhinitis eosinophilic rhinitis, etc.; patients with severe nasal septum deviation, sinusitis, nasal polyps, hypertrophic rhinitis Other nasal organic lesions;
* In the nasal examination at the end of the screening period or the introduction period, there is any erosion of the nasal mucosa, septal ulcer or perforation of the nasal septum;
* Those who have undergone sinus surgery within 3 months before the screening period or who have not fully healed the nasal wound;
* The subject has uncontrolled diabetes mellitus, that is, fasting blood glucose (FBG) \> 10mmol/L in the laboratory test during the screening period;
* History of allergy to any study drug or similar chemical drugs (CRTh2 antagonists);
* History of severe allergic reaction to any allergen, such as anaphylactic shock or life-threatening asthma, previous intubation, respiratory arrest, hospitalization for asthma or acute asthma attack within the past 3 months;
* Those who were found to respond to placebo during the lead-in period (with rhinitis symptoms of moderate or above during the screening period, those with mild or no symptoms during the lead-in period, or baseline rTNSS mean \<6 points were defined as placebo responders;
* Women who are pregnant or breastfeeding, or who plan to become pregnant or breastfeeding during the study period;
* Any subject deemed unsuitable for participation in this clinical study by the investigator.

Primary outcomes:
measure: Total nasal symptom Score (TNSS)
timeFrame: Baseline, Day 14
Secondary outcomes:
measure: Total ocular symptom score(TOSS)
timeFrame: Baseline, Day 14
measure: Individual Total Nasal Symptom Score (TNSS)
timeFrame: Baseline, Day 14
measure: Individual Total Ocular Symptom Score (TOSS)
timeFrame: Baseline, Day 14
measure: Daily symptoms score (dSS)
timeFrame: Baseline, Day 14
measure: Rescue medication proportion
timeFrame: Day 1-32
measure: Rescue medication frequency
timeFrame: Day 1-32
measure: Incidence of adverse events
timeFrame: Day 1-32
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
Study officials:
References: