Efficacy and Safety of CP006 Inhalation Powder in Participants With Asthma

NCT07807007 | Completed Phase 2

• 2 other identifiers: SHXHH-CP006-CT-A01CTR20254001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 13

Brief Summary

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.

Conditions

Asthma

Keywords

Asthma; Budesonide; Formoterol; Umeclidinium; Inhalation Powder; Triple Therapy; Phase II

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Morning Pre-dose Trough FEV₁ at Day 29

  Forced expiratory volume in one second (FEV₁) measured before the morning dose of study medication (after at least 12 hours since the last dose) at Day 29. Change from baseline is calculated as the Day 29 value minus the baseline value (measured at Day 0 before the first dose).

  Baseline (Day 0) and Day 29

Secondary Outcomes (11)

• Change from Baseline in Morning Pre-dose Trough FEV₁ at Day 8 and Day 15

  Baseline (Day 0), Day 8, and Day 15

• Change from Baseline in Mean Morning and Evening Pre-dose PEF at Day 7, Day 14, and Day 28

  Baseline (7 days prior to randomization), Day 7, Day 14, and Day 28

• Change from Baseline in Mean Daily PEF Diurnal Variability at Week 4

  Baseline (7 days prior to randomization) and Week 4

• Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score at Day 15 and Day 29

  Baseline (Day 0), Day 15, and Day 29

• Change from Baseline in Asthma Control Questionnaire (ACQ-5) Score at Day 8, Day 15, and Day 29

  Baseline (Day 0), Day 8, Day 15, and Day 29

Study Arms (3)

CP006 Dose 1 (BUD/FORM/UMEC 390/11/55 μg/day)

EXPERIMENTAL

Participants receive CP006 Inhalation Powder (budesonide/formoterol/umeclidinium) at 195 μg/5.5 μg/27.5 μg per inhalation, 1 inhalation twice daily (total daily dose 390 μg/11 μg/55 μg), for 28 days. Also receive placebo matching the comparator to maintain blinding.

Drug: Budesonide, Formoterol Fumarate, and Umeclidinium Bromide; Drug: Placebo for Budesonide and Formoterol Fumarate; Drug: Albuterol Sulfate

CP006 Dose 2 (BUD/FORM/UMEC 390/11/27.5 μg/day)

EXPERIMENTAL

Participants receive CP006 Inhalation Powder (budesonide/formoterol/umeclidinium) at 195 μg/5.5 μg/13.8 μg per inhalation, 1 inhalation twice daily (total daily dose 390 μg/11 μg/27.5 μg), for 28 days. Also receive placebo matching the comparator to maintain blinding.

Drug: Budesonide, Formoterol Fumarate, and Umeclidinium Bromide; Drug: Placebo for Budesonide and Formoterol Fumarate; Drug: Albuterol Sulfate

Active Comparator (BUD/FORM 640/18 μg/day)

ACTIVE COMPARATOR

Participants receive budesonide/formoterol inhalation powder (Symbicort® Turbuhaler®) at 160 μg/4.5 μg per inhalation, 2 inhalations twice daily (total daily dose 640 μg/18 μg), for 28 days. Also receive placebo matching the investigational drug to maintain blinding.

Drug: Budesonide and Formoterol Fumarate; Drug: Placebo for CP006 Inhalation Powder; Drug: Albuterol Sulfate

Interventions

Budesonide and Formoterol Fumarate DRUG

Budesonide and formoterol fumarate inhalation powder (Symbicort® Turbuhaler®), 160 μg/4.5 μg per inhalation. Administered as 2 inhalations twice daily for 28 days.

Also known as: Symbicort® Turbuhaler®

Active Comparator (BUD/FORM 640/18 μg/day)

Placebo for Budesonide and Formoterol Fumarate DRUG

Placebo matching budesonide and formoterol fumarate inhalation powder (Symbicort® Turbuhaler®). Contains no active pharmaceutical ingredients. Administered as 2 inhalations twice daily for 28 days to maintain blinding.

CP006 Dose 1 (BUD/FORM/UMEC 390/11/55 μg/day); CP006 Dose 2 (BUD/FORM/UMEC 390/11/27.5 μg/day)

Albuterol Sulfate DRUG

Albuterol sulfate inhalation aerosol (Ventolin®), 100 μg per actuation. Used as rescue medication on an as-needed basis for asthma symptoms during the run-in and treatment periods.

Active Comparator (BUD/FORM 640/18 μg/day); CP006 Dose 1 (BUD/FORM/UMEC 390/11/55 μg/day); CP006 Dose 2 (BUD/FORM/UMEC 390/11/27.5 μg/day)

Budesonide, Formoterol Fumarate, and Umeclidinium Bromide DRUG

CP006 Inhalation Powder, 195 μg/5.5 μg/27.5 μg per inhalation. Administered as 1 inhalation twice daily for 28 days. Contains budesonide 195 μg, formoterol fumarate 5.5 μg, and umeclidinium bromide (equivalent to umeclidinium 27.5 μg) per inhalation.

Also known as: CP006 Inhalation Powder (High Dose: 195/5.5/27.5 µg)

CP006 Dose 1 (BUD/FORM/UMEC 390/11/55 μg/day)

Placebo for CP006 Inhalation Powder DRUG

Placebo matching CP006 Inhalation Powder. Contains no active pharmaceutical ingredients. Administered as 1 inhalation twice daily for 28 days to maintain blinding.

Active Comparator (BUD/FORM 640/18 μg/day)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and comply with study procedures, willing to complete the study as per protocol, and provide written informed consent.
• Age 18 to 75 years (inclusive), both sexes, BMI \< 40 kg/m².
• 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.
• Regular daily use of medium/high-dose ICS/LABA regimen (including stable ICS dose) for at least 4 weeks prior to Visit 1.
• Non-smoker, or smoking cessation for at least 6 months (including cigarettes, cigars, pipe tobacco), with smoking history ≤ 30 pack-years.
• 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.
• Pre-bronchodilator FEV₁ ≥ 40% and ≤ 85% of predicted normal value at screening.
• 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.

You may not qualify if:

• Allergy to any sympathomimetic amines (e.g., formoterol or salbutamol), glucocorticoids, or excipient lactose.
• 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.
• 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.
• 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.
• 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.
• 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).
• Hepatic or renal impairment defined as ALT \> 2×ULN, AST \> 2×ULN, or serum creatinine \> 1.5×ULN.
• History of familial hypokalemia or conditions predisposing to severe hypokalemia, or serum potassium below the lower limit of normal at screening.
• Current or history of glaucoma, cataract, symptomatic prostatic hypertrophy, urinary retention, or bladder neck obstruction.
• Poorly controlled diabetes mellitus (fasting blood glucose \> 10 mmol/L on 2 consecutive non-fasting days or HbA1c ≥ 8.0%).
• 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).
• Use of inhaled short-acting anticholinergics, inhaled short-acting β₂-agonists (other than study drug), or combinations thereof within 24 hours prior to screening.
• Use of LAMA or LAMA-containing combination products within 4 weeks prior to screening.
• 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.
• Use of theophyllines, oral sustained-release bronchodilators, antihistamines, or anti-allergic drugs for asthma within 1 week prior to screening.

Sponsors & Collaborators

• Shanghai Xin Huanghe Pharmaceutical Co., Ltd.: lead

Study Sites (13)

Hefei First People's Hospital

Hefei, Anhui, 230061, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Chongqing Fuling Central Hospital

Chongqing, Chongqing Municipality, 408099, China

Location

Gansu Provincial Hospital

Lanzhou, Gansu, 730000, China

Location

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050031, China

Location

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, 453100, China

Location

Huai'an First People's Hospital

Huai'an, Jiangsu, 223300, China

Location

Lianyungang First People's Hospital

Lianyungang, Jiangsu, 222002, China

Location

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215004, China

Location

Yan'an University Xianyang Hospital

Xianyang, Shaanxi, 712000, China

Location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Zhongjiang People's Hospital

Kaijiang, Sichuan, 618100, China

Location

Mianyang Central Hospital

Mianyang, Sichuan, 621099, China

Location

MeSH Terms

Conditions

Asthma

Interventions

Budesonide; Formoterol Fumarate; Albuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, double-blind, double-dummy, parallel-group, active-controlled, multicenter Phase II study. Participants are assigned in a 1:1:1 ratio to one of three parallel treatment arms.

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 8, 2026
• Study Start: November 21, 2025
• Primary Completion: August 3, 2026
• Study Completion: August 17, 2026
• Last Updated: September 8, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (13)