Allergic RhinitisPhase 1NCT05607446
To Evaluate the Efficacy and Safety of TQC3564 Tablets in the Treatment of Persistent Allergic Rhinitis
A Phase 1 study testing TQC3564 tablets and TQC3564 tablets, montelukast sodium tablets in people with Allergic Rhinitis, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- TQC3564 tablets and TQC3564 tablets, montelukast sodium tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 14 Sep 2022to 14 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Allergic Rhinitis
- Being tested
- TQC3564 tablets, Placebo tablets, TQC3564 tablets, montelukast sodium tablets, Placebo tablets, montelukast sodium tablets
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQC3564 tabletsDrug
TQC3564 tablets are CRTH2 antagonists.
Placebo tabletsDrug
The intervention drug is placebo.
TQC3564 tablets, montelukast sodium tabletsDrug
The intervention drugs are TQC3564 tablets combined with montelukast sodium tablets. TQC3564 is a CRTH2 antagonist, montelukast sodium is Leukotriene receptor antagonist.
Placebo tablets, montelukast sodium tabletsDrug
The intervention drugs are placebo combined with montelukast sodium tablets. Montelukast sodium is Leukotriene receptor antagonist.
| Study group | Role | What they receive |
|---|---|---|
| TQC3564 tablets | Experimental | Orally administer TQC3564 tablets for 14 days. Receives: Drug: TQC3564 tablets |
| placebo tablets | Placebo comparator | Orally administer placebo tablets for 14 days. Receives: Drug: Placebo tablets |
| TQC3564 tablets + montelukast sodium tablets | Experimental | Orally administer TQC3546 tablets combined with Montelukast sodium tablets for 14 days. Receives: Drug: TQC3564 tablets, montelukast sodium tablets |
| placebo tablets + montelukast sodium tablets | Placebo comparator | Orally administer placebo tablets combined with Montelukast sodium tablets for 14 days. Receives: Drug: Placebo tablets, montelukast sodium tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Day 14
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Day 14
Rescue medication proportion
Proportion of participants using rescue medication mometasone furoate nasal spray during intervention
Measured: Day 1-32
Rescue medication frequency
Frequency of using rescue medication mometasone furoate nasal spray during intervention
Measured: Day 1-32
Incidence of adverse events
Incidence of adverse events, including vital signs, physical examination, abnormal laboratory parameters, etc.,
Measured: Day 1-32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start14 Sep 2022
- Primary completion9 May 2023
- Study completion14 Dec 2023
Why it stopped: This study was closed per sponsor request. Premature closure was not prompted by any safety or efficacy concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607446
- Sponsor's protocol ID
- TQC3564-Ib-02
- Status last verified
- Nov 2024
- First submitted
- 16 Oct 2022
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05607446
- Acronym / sponsor ID
- TQC3564-Ib-02
- Conditions
- Allergic Rhinitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was closed per sponsor request. Premature closure was not prompted by any safety or efficacy concerns.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 9 May 2023 (actual)
- Study completion
- 14 Dec 2023 (actual)
- First posted
- 7 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TQC3564 tablets | Experimental | Drug: TQC3564 tabletsOrally administer TQC3564 tablets for 14 days. |
| placebo tablets | Placebo comparator | Drug: Placebo tabletsOrally administer placebo tablets for 14 days. |
| TQC3564 tablets + montelukast sodium tablets | Experimental | Drug: TQC3564 tablets, montelukast sodium tabletsOrally administer TQC3546 tablets combined with Montelukast sodium tablets for 14 days. |
| placebo tablets + montelukast sodium tablets | Placebo comparator | Drug: Placebo tablets, montelukast sodium tabletsOrally administer placebo tablets combined with Montelukast sodium tablets for 14 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- 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.
Key exclusion criteria (9 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQC3564 tabletsTQC3564 tablets are CRTH2 antagonists. | Drug | TQC3564 tablets |
| Placebo tabletsThe intervention drug is placebo. | Drug | placebo tablets |
| TQC3564 tablets, montelukast sodium tabletsThe intervention drugs are TQC3564 tablets combined with montelukast sodium tablets. TQC3564 is a CRTH2 antagonist, montelukast sodium is Leukotriene receptor antagonist. | Drug | TQC3564 tablets + montelukast sodium tablets |
| Placebo tablets, montelukast sodium tabletsThe intervention drugs are placebo combined with montelukast sodium tablets. Montelukast sodium is Leukotriene receptor antagonist. | Drug | placebo tablets + montelukast sodium tablets |
Primary outcome
Total nasal symptom Score (TNSS)
Time frame: Baseline, Day 14
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.
7 secondary outcomes
Total ocular symptom score(TOSS)
Time frame: Baseline, Day 14
Individual Total Nasal Symptom Score (TNSS)
Time frame: Baseline, Day 14
Individual Total Ocular Symptom Score (TOSS)
Time frame: Baseline, Day 14
Daily symptoms score (dSS)
Time frame: Baseline, Day 14
Rescue medication proportion
Time frame: Day 1-32
Rescue medication frequency
Time frame: Day 1-32
Incidence of adverse events
Time frame: Day 1-32
Results and safety
The study was stopped early (reason given: This study was closed per sponsor request. Premature closure was not prompted by any safety or efficacy concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TQC3564 tablets and TQC3564 tablets, montelukast sodium tablets in people with Allergic Rhinitis, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. 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 7 inclusion and 9 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: stopped early, as of the sponsor's last update on 26 Nov 2024. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: This study was closed per sponsor request. Premature closure was not prompted by any safety or efficacy concerns.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total nasal symptom Score (TNSS) (time frame: Baseline, Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2024.