To Evaluate the Efficacy and Safety of TQC3564 Tablets in the Treatment of Persistent Allergic Rhinitis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Drug: TQC3564 tablets; Drug: Placebo tablets; Drug: TQC3564 tablets, montelukast sodium tablets; Drug: Placebo tablets, montelukast sodium tablets

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Zhi hai Xie, Doctor; Phone Number: +86 15111013198; Email: xiedoctor@126.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410008
      • Recruiting
      • Xiangya Hospital Central South University
      • Contact: Zhi hai Xie, Doctor; Phone Number: 15111013198; Email: xiedoctor@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TQC3564 tablets; Orally administer TQC3564 tablets for 14 days.	Drug: TQC3564 tablets; TQC3564 tablets are CRTH2 antagonists.
Placebo Comparator: placebo tablets; Orally administer placebo tablets for 14 days.	Drug: Placebo tablets; The intervention drug is placebo.
Experimental: TQC3564 tablets + montelukast sodium tablets; Orally administer TQC3546 tablets combined with Montelukast sodium tablets for 14 days.	Drug: TQC3564 tablets, montelukast sodium tablets; The intervention drugs are TQC3564 tablets combined with montelukast sodium tablets. TQC3564 is a CRTH2 antagonist, montelukast sodium is Leukotriene receptor antagonist.
Placebo Comparator: placebo tablets + montelukast sodium tablets; Orally administer placebo tablets combined with Montelukast sodium tablets for 14 days.	Drug: Placebo tablets, montelukast sodium tablets; The intervention drugs are placebo combined with montelukast sodium tablets. Montelukast sodium is Leukotriene receptor antagonist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total nasal symptom Score (TNSS)	Change in the investigator-assessed total nasal symptom score (TNSS) from baseline to 14 days. TNSS was the sum score of 4 nasal symptoms with a minimum score of 0 units and a maximum score of 12 units, with higher score corresponding to increased nasal allergy symptoms.	Baseline, Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total ocular symptom score(TOSS)	Change in the TOSS from baseline to14 days. TOSS was the sum of 2 ocular symptoms with a minimum score of 0 units and amaximum score of 6 units, with higher score corresponding to increased ocular symptoms.	Baseline, Day 14
Individual Total Nasal Symptom Score (TNSS)	Change in the individual TNSS from baseline to 14 days. Individual nasal symptoms were each rated on a 4-point scale from 0-3 (0=Absent, 1=Mild, 2=Moderate, 3=Severe), with no half-unit assessments.	Baseline, Day 14
Individual Total Ocular Symptom Score (TOSS)	Change in the individual TOSS from baseline to 14 days. Individual ocular symptoms were each rated on a 4-point scale from 0-3 (0=Absent, 1=Mild, 2=Moderate, 3=Severe), with no half-unit assessments.	Baseline, Day 14
Daily symptoms score (dSS)	Change in the dSS from baseline to 14 days. dSS was the sum of 4 nasal symptoms and 2 ocular symptoms with a minimum score of 0 units and amaximum score of 18 units, with higher score corresponding to increased overall symptoms.	Baseline, Day 14
Rescue medication proportion	Proportion of participants using rescue medication mometasone furoate nasal spray during intervention	Day 1-32
Rescue medication frequency	Frequency of using rescue medication mometasone furoate nasal spray during intervention	Day 1-32
Incidence of adverse events	Incidence of adverse events, including vital signs, physical examination, abnormal laboratory parameters, etc.,	Day 1-32

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2022
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: October 16, 2022
• First Submitted That Met QC Criteria: November 1, 2022
• First Posted (Actual): November 7, 2022

Study Record Updates

• Last Update Posted (Actual): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Montelukast
• Other Study ID Numbers: TQC3564-Ib-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No