NCT06035393
Terminated
Phase 2
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
ConditionsChronic Obstructive Pulmonary Disease
Overview
- Phase
- Phase 2
- Intervention
- HRG2005 inhalation
- Conditions
- Chronic Obstructive Pulmonary Disease
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- Change from baseline in morning pre-dose trough FEV1 at week 12
- Status
- Terminated
- Last Updated
- 4 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Able and willing to provide written informed consent and to comply with the study protocol;
- •Subjects 40 years of age or older (inclusive), Male or female subjects;
- •Subjects with an established clinical history of COPD;
- •A post-bronchodilator FEV1/FVC ratio must be \<0.7 at Screening and FEV1 must be \<80% and ≥30% predicted normal at pre-randomization;
- •Tobacco Use: Current or former smokers with a history of at least 10 pack-years of cigarette smoking.;
- •A score of ≥10 on the COPD Assessment Test (CAT) at pre-randomization.
Exclusion Criteria
- •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;
- •Subjects who had respiratory tract infections that required antibiotics within 2 weeks prior to Screening;
- •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;
- •Subjects with lung volume reduction surgery within the 12 months prior to Screening;
- •Subjects who have Other known serious medical conditions；
- •Subjects receiving oxygen therapy required for greater than 15 hours a day;
- •Clinically significant electrocardiogram abnormality；
- •Subjects with significant laboratory abnormality at screening；
- •Suspected allergy to any ingredient in the study drug;
- •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);
Arms & Interventions
Treatment group C
Drug1 dose 3+Drug 2+Drug 3
Intervention: HRG2005 inhalation
Treatment group A
Drug1 dose 1+Drug 3
Intervention: HRG2005 inhalation
Treatment group A
Drug1 dose 1+Drug 3
Intervention: Placebo to match Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation
Treatment group B
Drug1 dose 2+Drug 2+Drug 3
Intervention: HRG2005 inhalation
Treatment group B
Drug1 dose 2+Drug 2+Drug 3
Intervention: Placebo to match HRG2005 inhalation
Treatment group B
Drug1 dose 2+Drug 2+Drug 3
Intervention: Placebo to match Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation
Treatment group C
Drug1 dose 3+Drug 2+Drug 3
Intervention: Placebo to match HRG2005 inhalation
Treatment group C
Drug1 dose 3+Drug 2+Drug 3
Intervention: Placebo to match Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation
Treatment group D
Drug 2+Drug 4
Intervention: Placebo to match HRG2005 inhalation
Treatment group D
Drug 2+Drug 4
Intervention: Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation
Outcomes
Primary Outcomes
Change from baseline in morning pre-dose trough FEV1 at week 12
Time Frame: Up to week 12
Secondary Outcomes
- Peak change from baseline in FEV1 at week 12(Up to week 12)
- Change from baseline in morning pre-dose trough FEV1 at each time point(up to week 48)
- Compared with the active-controlled group in morning pre-dose trough FEV1 at each time point(up to week 48)
- Rate of moderate or severe COPD exacerbations over 48 Weeks(up to week 48)
- Change from baseline in CAT (COPD Assessment test) total score at each time point(up to week 48)
- Proportion of subjects achieving an improvement from baseline≥100mL in morning pre-dose trough FEV1(up to week 48)
- FEV1 area under the curve from 0 to 12 hours (AUC0-12), 0 to 24 (AUC0-24) hours at Week 12(Up to week 12)
- Rate of severe COPD exacerbations over 48 Weeks(up to week 48)
- Percentage of Days with No Rescue use and change from baseline in average daily rescue use at each time point(up to week 48)
- Incidence and severity of adverse events(Up to week 50)
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 2
Randomized Study of Obicetrapib in Combination With EzetimibeDyslipidemiasHigh CholesterolHypercholesterolemiaNCT04770389NewAmsterdam Pharma112
Not yet recruiting
Phase 2
A clinical experimental study to evaluate the benefits and risks of PF-06865571 alone and when coadministered with PF-05221304 in patients with Non alcoholic hepatitis (NASH)and FibrosisHealth Condition 1: K760- Fatty (change of) liver, not elsewhere classifiedCTRI/2020/10/028440Pfizer Inc
Active, not recruiting
Phase 1
Commercial study conducted to determine the most adequate supplementation of vitamin D in patients showing a kidney disease, a vitamin D deficiency and a high level of parathyroid hormone in the blood.chronic kidney disease, stage 3 with secondary hyperparathyroidism and vitamin D deficiencyMedDRA version: 21.1Level: HLGTClassification code 10038430Term: Renal disorders (excl nephropathies)System Organ Class: 10038359 - Renal and urinary disordersMedDRA version: 20.0Level: PTClassification code 10020708Term: Hyperparathyroidism secondarySystem Organ Class: 10014698 - Endocrine disordersTherapeutic area: Diseases [C] - Hormonal diseases [C19]EUCTR2019-000640-10-BGABORATOIRES SMB S.A.100
Active, not recruiting
Phase 1
Estudio fase II doble ciego, aleatorizado, controlado con placebo y mesalazina de seguridad y actividad de dersalazina en pacientes con colitis activa leve o moderada.A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitisEUCTR2008-004610-27-ESPalau Pharma S.A.90
Active, not recruiting
Phase 1
A randomized (subjects chosen at random), double-blind (subject andinvestigator blind, sponsor open) placebo-controlled (some subjects will receive placebo) trial to evaluate the safety, tolerability and antiviralactivity of ACH-0141625 taken orally when combined with pegylated interferon alfa-2a and ribavirin, after 28 days dosing and after 12 weeks of dosing in subjects who have chronic hepatitis C.Hepatitis C Virus Genotype 1MedDRA version: 14.0Level: LLTClassification code 10019751Term: Hepatitis C virusSystem Organ Class: 10022891 - InvestigationsMedDRA version: 14.0Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]EUCTR2010-022092-65-DEAchillion Pharmaceuticals, Inc.