Chronic Obstructive Pulmonary DiseasePhase 2NCT05987371
A Clinical Trial of TQC3721 Suspension for Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease.
A Phase 2 study testing TQC3721 suspension for inhalation and Salbutamol sulfate inhalation aerosol in people with Chronic Obstructive Pulmonary Disease, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 11 sites in China.
Trial summary
This is a phase II clinical trial to evaluate the efficacy and safety of TQC3721 Suspension for Inhalation in patients with moderate to severe Chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- TQC3721 suspension for inhalation and Salbutamol sulfate inhalation aerosol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 11 sitesChina
- Study dates
- 23 Aug 2023to 23 Apr 2024
- Phase
- Phase 2
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign an informed consent form before the study and fully understand the content, process, and potential adverse reactions of the experiment;
- Capable of using the study nebulizer correctly and complying with all study restrictions and procedures;
- Aged between 30 and 75 years old (Including critical values), both men and women;
- Body mass index(BMI) within the range of 18-30 kg/m2 (Including critical values);
- The subject has no pregnancy plan and voluntarily adopts effective contraceptive measures for at least one month from screening until the last use of the study drug;
- Diagnosed as a COPD patient according to the Global initiative for chronic obstructive lung disease (GOLD) 2023 standard, and had symptoms that met COPD for at least 1 year before screening;
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- Able to conduct acceptable and repeatable lung function measurements;
- Clinical stability of COPD within 4 weeks before screening visit (V1) and between V1 visit and V2 visit;
- Long acting Bronchiectasis or short acting Bronchiectasis were not regularly used at least 14 days before screening visit (V1);
- Long acting Bronchiectasis can be stopped during the study until the end of the study, and short acting Bronchiectasis can be stopped at least 6 hours before the pulmonary function test;
- Meet the restrictions on combination medication and expect to maintain the restrictions during treatment;
- Current smoking or smoking history ≥ 10 pack years (smoking at least 20 cigarettes per day for 10 consecutive years or smoking at least 10 cigarettes per day for 20 consecutive years, former cigarette smokers must stop smoking>6 months before visit 1).
Who cannot join
- A history of life-threatening COPD, including hospitalization in an intensive care unit and/or the need for intubation.
- Acute exacerbations of COPD requiring oral or parenteral steroid treatment within 3 months before screening (V1) or before randomization (V2).
- Received inhaled corticosteroids (ICS) treatment within 4 weeks prior to screening.
- Have a history of hospitalization for COPD at least once within 6 months prior to screening.
- Antibiotic treatment for upper and/or lower respiratory tract infection within 6 weeks before screening or before randomized visit (V2). Note: Patients with a history of upper/lower respiratory tract infection within 6 weeks cannot participate in the test, but can be re-screened 6 weeks after the infection is cured.
- COVID-19:
Show all 34Show fewer
- Suspected or confirmed COVID-19 infection during screening (V1), confirmed by the laboratory or based on the medical judgment of the researcher; Subjects who are known to have contact with COVID-19 positive patients. Note: Subjects should remain Asymptomatic for 14 days or more after exposure, and only after being approved by the investigator can they be re-screened.
- Known COVID-19 infection history within 4 weeks before screening (V1);
- Known medical history of hospitalization due to COVID-19 within 3 months before screening (V1);
- Subjects who had COVID-19 infection before screening (V1) and had not fully recovered to participate in clinical trial operations.
- Suffering from other respiratory diseases simultaneously: α- 1. Antitrypsin deficiency, primary ciliary dyskinesia, lung cancer; Respiratory diseases such as active pulmonary infection, pulmonary tuberculosis, Bronchiectasis, Pulmonary fibrosis, pulmonary Sarcoidosis, pulmonary hypertension, etc. with significant clinical significance assessed by the researchers.
- Chest computed tomography (CT) has found clinically significant abnormalities and believes that the abnormalities are not caused by COPD, and the researchers have determined that they have an impact on the trial results or patient safety. If there is no chest CT report within 3 months before visit 1, a chest CT examination must be performed on visit 1.
- Previously underwent pneumonectomy or lung reduction surgery.
- Previously received lung rehabilitation treatment (those who have been stable for 4 weeks before screening and have remained stable during the trial period can be selected).
- Received oral steroids or roflumilast treatment for COPD within 3 months before screening (Visit 1), or received oral theophylline and/or theophylline derivatives treatment for COPD within 1 months before screening (V1).
- Use non-selective oral administration β Receptor blockers.
- Previously received treatment with ensifentrine and HRS-9821.
- Patients receiving immunotherapy (such as Azathioprine and Cyclophosphamide) within 4 weeks before the screening period.
- The researcher evaluated that during the screening and treatment stages of this study, patients were unable to discontinue the prohibited drugs specified in the protocol.
- The patient has a history of diseases that cannot be controlled at present, including but not limited to diseases of endocrine, thyroid, nervous system, liver, gastrointestinal tract, kidney, blood, Urinary system, immunology or ophthalmic diseases which the investigator judges are clinically significant.
- History or current evidence of cardiovascular diseases with clinical significance. It is defined as any disease that the investigator believes will endanger the safety of patients when participating in the study, or any disease that may affect the effectiveness or safety analysis if the disease/condition worsens during the study; Subjects who have experienced any of the following conditions during visit 1 will be excluded:
- myocardial infarction, unstable angina, or stroke within the past 6 months;
- There have been unstable or life-threatening arrhythmia requiring intervention within the past 3 months;
- New York Heart Association (NYHA) III-IV Heart Failure.
- Have unstable or uncontrollable hypertension.
- Major surgery (requiring general anesthesia) was performed within 8 weeks before the screening visit (V1), or the patient did not fully recover from the surgery during the screening visit (V1), or surgery was planned before the end of the study.
- A history of cured or uncured malignant tumors in any organ or system in the past 5 years.
- Intolerance or allergy to Salbutamol or TQC3721.
- Those who require oxygen therapy, even occasionally.
- Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study.
- Persons who have received live attenuated vaccine within 28 days before randomization, Inactivated vaccine within 7 days, or who plan to receive vaccination during the study period.
- Have a history of drug or alcohol abuse within the past 3 years.
- Individuals who have participated in any clinical trial of drugs or medical devices within 4 weeks or 5 drug half-lives (whichever is longer) prior to screening.
- The researcher believes that there are other situations that are not suitable for participation in the study.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites
The first hospital of Jilin University
Changchun, Jilin, 130021
Changsha Third Hospital
Changsha, Hunan, 410035
West China Hospital of Sichuan University
Chengdu, Sichuan, 610044
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000
Mianyang Central Hospital
Mianyang, Sichuan, 621099
People's Hospital of Jiangxi province
Nanchang, Jiangxi, 330006
Suining Central Hospital
Suining, Sichuan, 629000
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325088
Wuhan Sixth Hospital
Wuhan, Hubei, 430015
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225000
The Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524023
About this study
Official title: Randomized, Double-blind, Placebo-controlled, Dose Exploration, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQC3721 Suspension for Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease.
This is a phase II clinical trial to evaluate the efficacy and safety of TQC3721 Suspension for Inhalation in patients with moderate to severe Chronic obstructive pulmonary disease (COPD).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- TQC3721 suspension for inhalation, TQC3721 matching placebo for inhalation, Salbutamol sulfate inhalation aerosol
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQC3721 suspension for inhalationDrug
TQC3721 suspension for inhalation is a dual inhibitor targeting PDE3/4.
TQC3721 matching placebo for inhalationDrug
Placebo without active substance.
Salbutamol sulfate inhalation aerosolDrug
Salbutamol is short-acting β2 receptor agonists.
| Study group | Role | What they receive |
|---|---|---|
| TQC3721 Suspension for Inhalation (Twice a day)+ Salbutamol | Experimental | TQC3721 suspension for inhalation, twice a day for 4 weeks, Salbutamol sulfate inhalation aerosol is used as required. Receives: Drug: TQC3721 suspension for inhalation; Drug: Salbutamol sulfate inhalation aerosol |
| TQC3721 Suspension for Inhalation (Once a day)+ Salbutamol | Experimental | TQC3721 suspension for inhalation, once a day for 4 weeks, Salbutamol sulfate inhalation aerosol is used as required. Receives: Drug: TQC3721 suspension for inhalation; Drug: Salbutamol sulfate inhalation aerosol |
| TQC3721 matching placebo for inhalation (Twice a day)+ Salbutamol | Placebo comparator | TQC3721 suspension placebo for inhalation, twice a day for 4 weeks, Salbutamol sulfate inhalation aerosol is used as required. Receives: Drug: TQC3721 matching placebo for inhalation; Drug: Salbutamol sulfate inhalation aerosol |
| TQC3721 matching placebo for inhalation (once a day)+ Salbutamol | Placebo comparator | TQC3721 suspension placebo for inhalation, once a day for 4 weeks, Salbutamol sulfate inhalation aerosol is used as required. Receives: Drug: TQC3721 matching placebo for inhalation; Drug: Salbutamol sulfate inhalation aerosol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The peak of Forced Expiratory Volume in the 1st second (FEV1) (4 weeks)
Change of the maximum value of FEV1 from baseline to four weeks after treatment
Measured: From baseline to four weeks after treatment.
Secondary outcomes (29)
Morning trough FEV1
The FEV1 before administration
Measured: From baseline to four weeks after treatment.
Average FEV1 (4 weeks)
Average FEV1 of 3 hours, 12 hours, 24 hours, 0-12 hours and 12-24 hours after administration.
Measured: From baseline to four weeks after treatment.
Changes in FEV1
Changes in FEV1 at each time point within 24 hours after administration
Measured: From baseline to four weeks after treatment.
COPD Assessment Test (CAT)
Change From Baseline to four weeks after treatment. The score range is 0 to 40 points (0 to 10 is minor influence; 11 to 20 are moderate; 21 to 30 are classified as severe impact; 31 to 40 is very severe).
Measured: From baseline to four weeks after treatment.
Modified Medical Research Council (mMRC) Dyspnea Scale Score
Change From Baseline to four weeks after treatment in mMRC Scoring. The questionnaire is mainly used to evaluate the degree of respiratory distress in patients with chronic obstructive pulmonary disease. According to the symptoms of respiratory distress, the questionnaire is divided into 5 levels, with 0-1 points as less symptoms and ≥ 2 points as more symptoms.
Measured: From baseline to four weeks after treatment.
The peak of FEV1 (two weeks)
Change of the maximum value of FEV1 from baseline to two weeks after treatment
Measured: From baseline to two weeks after treatment.
Trough FEV1
Change of trough FEV1 from baseline to two weeks after treatment.
Measured: From baseline to two weeks after treatment.
Average FEV1 within 3 hours
Average FEV1 within 3 hours after administration
Measured: From baseline to two weeks after treatment
Frequency of Rescue medication
Frequency of Rescue medication used group during the study in the experimental compared to that in the placebo group.
Measured: From baseline to four weeks after administration.
Plasma drug peak concentration (Cmax)
Plasma drug peak concentration after administration.
Measured: Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Time to maximum concentration (Tmax)
Time to maximum concentration (Tmax) after administration.
Measured: Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Area Under Curve (AUC)
Area under the drug concentration-time curve.
Measured: Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Elimination half-life (t1/2)
Apparent terminal elimination half-life after drug administration.
Measured: Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Apparent volume of distribution (Vd)
Apparent volume of distribution after drug administration.
Measured: Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Clearance (CL)
The total drug clearance rate of liver, kidney, etc.
Measured: Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Plasma concentration at steady state (Cav, SS)
The plasma concentration at which the rate of administration and rate of elimination are in equilibrium.
Measured: Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Minimum concentration (Cmin)
Plasma drug minimum concentration after administration.
Measured: Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Degree of fluctuation (DF)
The ratio of the difference between Cmax,ss and Cmin,ss to Cav,ss.
Measured: Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Steady state volume of distribution (Vss)
Steady state volume of distribution after administration.
Measured: Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Number of cases of adverse events
Number of cases of adverse events assessed by Common Terminology Criteria for Adverse Events ( CTCAE ) v5.0.
Measured: From baseline to four weeks after treatment.
Incidence of adverse events
Incidence of adverse events assessed by Common Terminology Criteria for Adverse Events ( CTCAE ) v5.0.
Measured: From baseline to four weeks after treatment.
Number of cases of serious adverse events.
Number of cases of serious adverse events assessed by Common Terminology Criteria for Adverse Events ( CTCAE ) v5.0.
Measured: From baseline to four weeks after treatment.
Incidence of serious adverse events.
Incidence of serious adverse events assessed by Common Terminology Criteria for Adverse Events ( CTCAE ) v5.0.
Measured: From baseline to four weeks after treatment.
Number of cases of adverse events related to study drug.
Number of cases of adverse events related to study drug assessed by CTCAE v5.0.
Measured: From baseline to four weeks after treatment.
Incidence of adverse events related to study drug.
Incidence of adverse events related to study drug assessed by CTCAE v5.0.
Measured: From baseline to four weeks after treatment.
The peak of FEV1 (Day 1).
Change of the maximum value of FEV1 from baseline to Day 1.
Measured: From baseline to Day 1.
The peak of FEV1 (Day 1 to 4 weeks)
Change of the maximum value of FEV1 from Day 1 to four weeks after treatment
Measured: From Day 1 to four weeks after treatment.
Average FEV1 (Day 2)
Average FEV1 of 3 hours, 12 hours, 24 hours, 0-12 hours and 12-24 hours after administration.
Measured: From baseline to 24 hours after first treatment.
Average FEV1 (Day 1 to 4 weeks)
Average FEV1 of 3 hours, 12 hours, 24 hours, 0-12 hours and 12-24 hours after administration.
Measured: From Day 1 to four weeks after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start23 Aug 2023
- Primary completion16 Jan 2024
- Study completion23 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 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
- NCT05987371
- Sponsor's protocol ID
- TQC3721-II-02
- Status last verified
- Apr 2025
- First submitted
- 4 Aug 2023
- Last updated
- 17 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled, Dose Exploration, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQC3721 Suspension for Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease.
- ClinicalTrials.gov ID
- NCT05987371
- Acronym / sponsor ID
- TQC3721-II-02
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 16 Jan 2024 (actual)
- Study completion
- 23 Apr 2024 (actual)
- First posted
- 14 Aug 2023 (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.
This is a phase II clinical trial to evaluate the efficacy and safety of TQC3721 Suspension for Inhalation in patients with moderate to severe Chronic obstructive pulmonary disease (COPD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TQC3721 Suspension for Inhalation (Twice a day)+ Salbutamol | Experimental | Drug: TQC3721 suspension for inhalation, Drug: Salbutamol sulfate inhalation aerosolTQC3721 suspension for inhalation, twice a day for 4 weeks, Salbutamol sulfate inhalation aerosol is used as required. |
| TQC3721 Suspension for Inhalation (Once a day)+ Salbutamol | Experimental | Drug: TQC3721 suspension for inhalation, Drug: Salbutamol sulfate inhalation aerosolTQC3721 suspension for inhalation, once a day for 4 weeks, Salbutamol sulfate inhalation aerosol is used as required. |
| TQC3721 matching placebo for inhalation (Twice a day)+ Salbutamol | Placebo comparator | Drug: TQC3721 matching placebo for inhalation, Drug: Salbutamol sulfate inhalation aerosolTQC3721 suspension placebo for inhalation, twice a day for 4 weeks, Salbutamol sulfate inhalation aerosol is used as required. |
| TQC3721 matching placebo for inhalation (once a day)+ Salbutamol | Placebo comparator | Drug: TQC3721 matching placebo for inhalation, Drug: Salbutamol sulfate inhalation aerosolTQC3721 suspension placebo for inhalation, once a day for 4 weeks, Salbutamol sulfate inhalation aerosol is used as required. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Sign an informed consent form before the study and fully understand the content, process, and potential adverse reactions of the experiment;
- Capable of using the study nebulizer correctly and complying with all study restrictions and procedures;
- Aged between 30 and 75 years old (Including critical values), both men and women;
- Body mass index(BMI) within the range of 18-30 kg/m2 (Including critical values);
- The subject has no pregnancy plan and voluntarily adopts effective contraceptive measures for at least one month from screening until the last use of the study drug;
Key exclusion criteria (34 listed)
- A history of life-threatening COPD, including hospitalization in an intensive care unit and/or the need for intubation.
- Acute exacerbations of COPD requiring oral or parenteral steroid treatment within 3 months before screening (V1) or before randomization (V2).
- Received inhaled corticosteroids (ICS) treatment within 4 weeks prior to screening.
- Have a history of hospitalization for COPD at least once within 6 months prior to screening.
- Antibiotic treatment for upper and/or lower respiratory tract infection within 6 weeks before screening or before randomized visit (V2). Note: Patients with a history of upper/lower respiratory tract infection within 6 weeks cannot participate in the test, but can be re-screened 6 weeks after the infection is cured.
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 |
|---|---|---|
| TQC3721 suspension for inhalationTQC3721 suspension for inhalation is a dual inhibitor targeting PDE3/4. | Drug | TQC3721 Suspension for Inhalation (Once a day)+ Salbutamol, TQC3721 Suspension for Inhalation (Twice a day)+ Salbutamol |
| TQC3721 matching placebo for inhalationPlacebo without active substance. | Drug | TQC3721 matching placebo for inhalation (Twice a day)+ Salbutamol, TQC3721 matching placebo for inhalation (once a day)+ Salbutamol |
| Salbutamol sulfate inhalation aerosolSalbutamol is short-acting β2 receptor agonists. | Drug | TQC3721 Suspension for Inhalation (Once a day)+ Salbutamol, TQC3721 Suspension for Inhalation (Twice a day)+ Salbutamol, TQC3721 matching placebo for inhalation (Twice a day)+ Salbutamol, TQC3721 matching placebo for inhalation (once a day)+ Salbutamol |
Primary outcome
The peak of Forced Expiratory Volume in the 1st second (FEV1) (4 weeks)
Time frame: From baseline to four weeks after treatment.
Change of the maximum value of FEV1 from baseline to four weeks after treatment
29 secondary outcomes
Morning trough FEV1
Time frame: From baseline to four weeks after treatment.
Average FEV1 (4 weeks)
Time frame: From baseline to four weeks after treatment.
Changes in FEV1
Time frame: From baseline to four weeks after treatment.
COPD Assessment Test (CAT)
Time frame: From baseline to four weeks after treatment.
Modified Medical Research Council (mMRC) Dyspnea Scale Score
Time frame: From baseline to four weeks after treatment.
The peak of FEV1 (two weeks)
Time frame: From baseline to two weeks after treatment.
Trough FEV1
Time frame: From baseline to two weeks after treatment.
Average FEV1 within 3 hours
Time frame: From baseline to two weeks after treatment
Frequency of Rescue medication
Time frame: From baseline to four weeks after administration.
Plasma drug peak concentration (Cmax)
Time frame: Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Time to maximum concentration (Tmax)
Time frame: Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Area Under Curve (AUC)
Time frame: Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Elimination half-life (t1/2)
Time frame: Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Apparent volume of distribution (Vd)
Time frame: Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Clearance (CL)
Time frame: Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Plasma concentration at steady state (Cav, SS)
Time frame: Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Minimum concentration (Cmin)
Time frame: Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Degree of fluctuation (DF)
Time frame: Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Steady state volume of distribution (Vss)
Time frame: Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Number of cases of adverse events
Time frame: From baseline to four weeks after treatment.
Incidence of adverse events
Time frame: From baseline to four weeks after treatment.
Number of cases of serious adverse events.
Time frame: From baseline to four weeks after treatment.
Incidence of serious adverse events.
Time frame: From baseline to four weeks after treatment.
Number of cases of adverse events related to study drug.
Time frame: From baseline to four weeks after treatment.
Incidence of adverse events related to study drug.
Time frame: From baseline to four weeks after treatment.
The peak of FEV1 (Day 1).
Time frame: From baseline to Day 1.
The peak of FEV1 (Day 1 to 4 weeks)
Time frame: From Day 1 to four weeks after treatment.
Average FEV1 (Day 2)
Time frame: From baseline to 24 hours after first treatment.
Average FEV1 (Day 1 to 4 weeks)
Time frame: From Day 1 to four weeks after treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
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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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TQC3721 suspension for inhalation and Salbutamol sulfate inhalation aerosol in people with Chronic Obstructive Pulmonary Disease, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 11 sites 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 12 inclusion and 34 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: finished, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The peak of Forced Expiratory Volume in the 1st second (FEV1) (4 weeks) (time frame: From baseline to four weeks after treatment.). 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 17 Apr 2025.