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

Primary Purpose

Allergic Rhinitis

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
TQC3564 tablets
Placebo tablets
TQC3564 tablets, montelukast sodium tablets
Placebo tablets, montelukast sodium tablets
Sponsored by
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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; Signs: Pale and edema of the nasal mucosa is common. Nasal watery secretions; 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.

Sites / Locations

  • Xiangya Hospital Central South UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

TQC3564 tablets

placebo tablets

TQC3564 tablets + montelukast sodium tablets

placebo tablets + montelukast sodium tablets

Arm Description

Orally administer TQC3564 tablets for 14 days.

Orally administer placebo tablets for 14 days.

Orally administer TQC3546 tablets combined with Montelukast sodium tablets for 14 days.

Orally administer placebo tablets combined with Montelukast sodium tablets for 14 days.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
Rescue medication proportion
Proportion of participants using rescue medication mometasone furoate nasal spray during intervention
Rescue medication frequency
Frequency of using rescue medication mometasone furoate nasal spray during intervention
Incidence of adverse events
Incidence of adverse events, including vital signs, physical examination, abnormal laboratory parameters, etc.,

Full Information

First Posted
October 16, 2022
Last Updated
November 1, 2022
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05607446
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TQC3564 tablets
Arm Type
Experimental
Arm Description
Orally administer TQC3564 tablets for 14 days.
Arm Title
placebo tablets
Arm Type
Placebo Comparator
Arm Description
Orally administer placebo tablets for 14 days.
Arm Title
TQC3564 tablets + montelukast sodium tablets
Arm Type
Experimental
Arm Description
Orally administer TQC3546 tablets combined with Montelukast sodium tablets for 14 days.
Arm Title
placebo tablets + montelukast sodium tablets
Arm Type
Placebo Comparator
Arm Description
Orally administer placebo tablets combined with Montelukast sodium tablets for 14 days.
Intervention Type
Drug
Intervention Name(s)
TQC3564 tablets
Intervention Description
TQC3564 tablets are CRTH2 antagonists.
Intervention Type
Drug
Intervention Name(s)
Placebo tablets
Intervention Description
The intervention drug is placebo.
Intervention Type
Drug
Intervention Name(s)
TQC3564 tablets, montelukast sodium tablets
Intervention Description
The intervention drugs are TQC3564 tablets combined with montelukast sodium tablets. TQC3564 is a CRTH2 antagonist, montelukast sodium is Leukotriene receptor antagonist.
Intervention Type
Drug
Intervention Name(s)
Placebo tablets, montelukast sodium tablets
Intervention Description
The intervention drugs are placebo combined with montelukast sodium tablets. Montelukast sodium is Leukotriene receptor antagonist.
Primary Outcome Measure Information:
Title
Total nasal symptom Score (TNSS)
Description
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.
Time Frame
Baseline, Day 14
Secondary Outcome Measure Information:
Title
Total ocular symptom score(TOSS)
Description
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.
Time Frame
Baseline, Day 14
Title
Individual Total Nasal Symptom Score (TNSS)
Description
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.
Time Frame
Baseline, Day 14
Title
Individual Total Ocular Symptom Score (TOSS)
Description
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.
Time Frame
Baseline, Day 14
Title
Daily symptoms score (dSS)
Description
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.
Time Frame
Baseline, Day 14
Title
Rescue medication proportion
Description
Proportion of participants using rescue medication mometasone furoate nasal spray during intervention
Time Frame
Day 1-32
Title
Rescue medication frequency
Description
Frequency of using rescue medication mometasone furoate nasal spray during intervention
Time Frame
Day 1-32
Title
Incidence of adverse events
Description
Incidence of adverse events, including vital signs, physical examination, abnormal laboratory parameters, etc.,
Time Frame
Day 1-32

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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: 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; Signs: Pale and edema of the nasal mucosa is common. Nasal watery secretions; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhi hai Xie, Doctor
Phone
+86 15111013198
Email
xiedoctor@126.com
Facility Information:
Facility Name
Xiangya Hospital Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhi hai Xie, Doctor
Phone
15111013198
Email
xiedoctor@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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