Efficacy and Safety of CP006 Inhalation Powder in Participants With Asthma

A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Active-Controlled, Multicenter Phase II Study to Evaluate the Efficacy and Safety of CP006 Inhalation Powder in Participants With Asthma

The goal of this clinical trial is to evaluate whether two different doses of an investigational drug (CP006 Inhalation Powder, a triple combination of budesonide, formoterol, and umeclidinium) improve lung function in adults with asthma compared to an active comparator (budesonide/formoterol inhalation powder, a marketed two-component product).

The main questions it aims to answer are:

Does CP006 produce a greater change in lung function (measured by trough FEV₁ before morning dose) after 28 days of treatment compared to the comparator? What medical problems do participants experience when taking CP006? Researchers will compare two dose levels of CP006 against the active comparator in a 1:1:1 ratio.

Participants will:

Complete a screening visit (up to 7 days) to confirm eligibility, including medical history, physical exam, and lung function tests Enter a 14-day run-in period during which they take the comparator medication (budesonide/formoterol) twice daily Be randomly assigned to one of three treatment groups: CP006 Dose 1, CP006 Dose 2, or the comparator Take their assigned treatment twice daily for 28 days Visit the clinic at Day 0 (baseline), Day 8, Day 15, and Day 29 for lung function tests, safety checks, and questionnaires (ACQ-5 and AQLQ) Measure their morning and evening peak expiratory flow (PEF) daily using a handheld device and record the results in a diary Return for a follow-up safety visit or phone call at Day 43 (±2 days) The total duration of participation is approximately 58 to 65 days.

Inclusion Criteria:

1. Ability to understand and comply with study procedures, willing to complete the study as per protocol, and provide written informed consent.
2. Age 18 to 75 years (inclusive), both sexes, BMI < 40 kg/m².
3. Diagnosis of bronchial asthma per Chinese Guidelines for the Prevention and Management of Asthma (2024 edition) with documented medical history ≥ 3 months, and currently inadequately controlled asthma as defined by ACQ-5 score ≥ 1.5.
4. Regular daily use of medium/high-dose ICS/LABA regimen (including stable ICS dose) for at least 4 weeks prior to Visit 1.
5. Non-smoker, or smoking cessation for at least 6 months (including cigarettes, cigars, pipe tobacco), with smoking history ≤ 30 pack-years.
6. Positive bronchodilator reversibility test within 1 year prior to screening; or, if not available, meet the reversibility criteria of FEV₁ increase ≥ 12% and absolute increase ≥ 200 mL during screening.
7. Pre-bronchodilator FEV₁ ≥ 40% and ≤ 85% of predicted normal value at screening.
8. Agree to have no fertility plan (including sperm or egg donation) and voluntarily use effective contraception (including partner) during the study and for 3 months after the last dose.

Exclusion Criteria:

1. Allergy to any sympathomimetic amines (e.g., formoterol or salbutamol), glucocorticoids, or excipient lactose.
2. Life-threatening asthma, defined as asthma exacerbation requiring non-invasive/invasive mechanical ventilation, and/or history of hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncope within 1 year prior to screening or during run-in.
3. Acute upper or lower respiratory bacterial infection requiring systemic antibiotic therapy within 4 weeks prior to screening or during run-in, which leads to changes in asthma treatment or may affect study participation per investigator's judgment.
4. Concurrent respiratory diseases other than asthma, including but not limited to idiopathic pulmonary fibrosis, clinically significant atelectasis, active tuberculosis, COPD, bronchiectasis, etc., which may place the subject at undue risk or affect study outcome assessment per investigator's judgment.
5. History of malignancy in any organ system within the past 5 years, except for early-stage tumors with low metastatic and mortality risk that have been curatively treated.
6. Severe cardiovascular disease, including but not limited to NYHA Class III-IV, severe arrhythmias such as QTcF prolongation (QTcF > 450 ms for males, > 460 ms for females), myocardial infarction or unstable angina within 6 months prior to screening, or poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg on 2 or more consecutive measurements).
7. Hepatic or renal impairment defined as ALT > 2×ULN, AST > 2×ULN, or serum creatinine > 1.5×ULN.
8. History of familial hypokalemia or conditions predisposing to severe hypokalemia, or serum potassium below the lower limit of normal at screening.
9. Current or history of glaucoma, cataract, symptomatic prostatic hypertrophy, urinary retention, or bladder neck obstruction.
10. Poorly controlled diabetes mellitus (fasting blood glucose > 10 mmol/L on 2 consecutive non-fasting days or HbA1c ≥ 8.0%).
11. History of drug abuse, substance abuse, or alcohol abuse within 1 year prior to screening (alcohol abuse defined as average daily alcohol intake > 2 units; 1 unit = 360 mL beer, or 45 mL of 40% liquor, or 150 mL wine).
12. Use of inhaled short-acting anticholinergics, inhaled short-acting β₂-agonists (other than study drug), or combinations thereof within 24 hours prior to screening.
13. Use of LAMA or LAMA-containing combination products within 4 weeks prior to screening.
14. Use of any marketed or investigational biologic agents for asthma (e.g., omalizumab, mepolizumab, benralizumab, reslizumab) within 3 months or 5 half-lives (whichever is longer) prior to screening.
15. Use of theophyllines, oral sustained-release bronchodilators, antihistamines, or anti-allergic drugs for asthma within 1 week prior to screening.
16. Use of anti-leukotriene agents within 48 hours prior to screening.
17. Use of tricyclic antidepressants, MAOIs, or SSRIs (e.g., fluoxetine, sertraline) within 4 weeks prior to screening, except for stable SSRI use for at least 4 weeks prior to screening.
18. Use of CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin) within 2 weeks prior to screening.
19. Use of systemic corticosteroids at a dose ≥ 20 mg/day prednisone or equivalent for more than 1 week within 4 weeks prior to screening, or use of systemic corticosteroids at ≥ 20 mg/day prednisone or equivalent within 1 week prior to screening.
20. Initiation of allergen immunotherapy within 4 weeks prior to screening, except for those who have been on stable-dose treatment for at least 4 weeks prior to screening and will maintain stable dose during the study.
21. Oral candidiasis suspected or confirmed by investigator on oral examination.
22. Participation in another clinical trial and receipt of investigational drug/treatment within 2 months prior to enrollment.
23. Pregnant or lactating females, or positive pregnancy test in women of childbearing potential.
24. Any other condition that, per investigator's judgment, may affect the assessment of efficacy or safety, or makes the subject unsuitable for enrollment.