Clinical trial NCT06035393: A Study to Assess the Efficacy and Safety of HRG2005 Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Official title: A Phase II, Randomized, Double Blind, Double Dummy, Active-controlled, Parallel-group Study to Assess the Efficacy and Safety of HRG2005 Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-09-13
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, double blind, double dummy, active-controlled, parallel-group study.
Primary purpose: TREATMENT

Brief summary: This is a randomized, double blind, double dummy, active-controlled, parallel-group study to assess the efficacy and Safety of HRG2005 inhalation in patients with moderate to severe chronic obstructive pulmonary disease. Approximately 200 patients with moderate to severe COPD will be randomized into the study.


Eligibility criteria: Inclusion Criteria:

1. Able and willing to provide written informed consent and to comply with the study protocol;
2. Subjects 40 years of age or older (inclusive), Male or female subjects;
3. Subjects with an established clinical history of COPD;
4. A post-bronchodilator FEV1/FVC ratio must be \<0.7 at Screening and FEV1 must be \<80% and ≥30% predicted normal at pre-randomization;
5. a documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbation in the previous 12 months;
6. Tobacco Use: Current or former smokers with a history of at least 10 pack-years of cigarette smoking;
7. A score of ≥10 on the COPD Assessment Test (CAT) at pre-randomization.

Exclusion Criteria:

1. Subjects who required systemic corticosteroids or antibiotics or hospitalized due to poorly controlled COPD or who had lower respiratory tract infections that required antibiotics within 4 weeks prior to Screening to pre-randomization;
2. Subjects who had respiratory tract infections that required antibiotics within 2 weeks prior to Screening to pre-randomization;
3. Subjects with other respiratory or respiratory related diseases, including but not limited to asthma, active tuberculosis, lung cancer, interstitial pulmonary disease, α1-antitrypsin deficiency, pulmonary heart disease, clinically significant pulmonary hypertension, clinically significant bronchiectasis, or other active pulmonary disease;
4. Subjects with lung volume reduction surgery within the 12 months prior to Screening;
5. Subjects who have Other known serious medical conditions；
6. Subjects receiving oxygen therapy required for greater than 15 hours a day;
7. Clinically significant electrocardiogram abnormality；
8. Subjects with significant laboratory abnormality at screening；
9. Suspected allergy to any ingredient in the study drug;
10. Participation in clinical trials of any drug or medical device (except for screening failures) within 4 weeks before screening, or within 5 half-lives of the drug at screening (whichever is longer);
11. Pregnant or lactating females;
12. History of drug abuse within one year before screening
13. Other conditions judged by the investigator to be not suitable to participate in the trial.

Primary outcomes:
measure: Change from baseline in morning pre-dose trough FEV1 at week 12
timeFrame: Up to week 12
Secondary outcomes:
measure: Change from baseline in morning pre-dose trough FEV1 at each time point
timeFrame: up to week 48
measure: Compared with the active-controlled group in morning pre-dose trough FEV1 at each time point
timeFrame: up to week 48
measure: Proportion of subjects achieving an improvement from baseline≥100mL in morning pre-dose trough FEV1
timeFrame: up to week 48
measure: Peak change from baseline in FEV1 at week 12
timeFrame: Up to week 12
measure: FEV1 area under the curve from 0 to 12 hours (AUC0-12), 0 to 24 (AUC0-24) hours at Week 12
timeFrame: Up to week 12
measure: Rate of moderate or severe COPD exacerbations over 48 Weeks
timeFrame: up to week 48
measure: Rate of severe COPD exacerbations over 48 Weeks
timeFrame: up to week 48
measure: Change from baseline in CAT (COPD Assessment test) total score at each time point
timeFrame: up to week 48
measure: Percentage of Days with No Rescue use and change from baseline in average daily rescue use at each time point
timeFrame: up to week 48
measure: Incidence and severity of adverse events
timeFrame: Up to week 50
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References: