AsthmaPhase 2CP006-ASTHMANCT07807007
Efficacy and Safety of CP006 Inhalation Powder in Participants With Asthma
A Phase 2 study testing Budesonide, Formoterol Fumarate, and Umeclidinium Bromide, Budesonide and Formoterol Fumarate and Albuterol Sulfate in people with Asthma, run by Shanghai Xin Huanghe Pharmaceutical Co., Ltd. at 13 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- Budesonide, Formoterol Fumarate, and Umeclidinium Bromide, Budesonide and Formoterol Fumarate and Albuterol Sulfate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 13 sitesChina
- Study dates
- 21 Nov 2025to 17 Aug 2026
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
- Use of anti-leukotriene agents within 48 hours prior to screening.
- 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.
- Use of CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin) within 2 weeks prior to screening.
- 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.
- 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.
- Oral candidiasis suspected or confirmed by investigator on oral examination.
- Participation in another clinical trial and receipt of investigational drug/treatment within 2 months prior to enrollment.
- Pregnant or lactating females, or positive pregnancy test in women of childbearing potential.
- Any other condition that, per investigator's judgment, may affect the assessment of efficacy or safety, or makes the subject unsuitable for enrollment.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Chongqing Fuling Central Hospital
Chongqing, Chongqing Municipality, 408099
Hefei First People's Hospital
Hefei, Anhui, 230061
Huai'an First People's Hospital
Huai'an, Jiangsu, 223300
Zhongjiang People's Hospital
Kaijiang, Sichuan, 618100
Gansu Provincial Hospital
Lanzhou, Gansu, 730000
Lianyungang First People's Hospital
Lianyungang, Jiangsu, 222002
Mianyang Central Hospital
Mianyang, Sichuan, 621099
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050031
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004
Yan'an University Xianyang Hospital
Xianyang, Shaanxi, 712000
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453100
About this study
Official title: 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:
Read more
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
- Being tested
- Budesonide, Formoterol Fumarate, and Umeclidinium Bromide, Budesonide and Formoterol Fumarate, Placebo for CP006 Inhalation Powder, Placebo for Budesonide and Formoterol Fumarate, Albuterol Sulfate
- Keywords
- Asthma, Budesonide, Formoterol, Umeclidinium, Inhalation Powder, Triple Therapy, Phase II
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide, Formoterol Fumarate, and Umeclidinium BromideDrug
Also called CP006 Inhalation Powder (High Dose: 195/5.5/27.5 µg)
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.
Budesonide, Formoterol Fumarate, and Umeclidinium BromideDrug
Also called CP006 Inhalation Powder (Low Dose: 195/5.5/13.8 µg)
CP006 Inhalation Powder, 195 μg/5.5 μg/13.8 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 13.8 μg) per inhalation.
Budesonide and Formoterol FumarateDrug
Also called Symbicort® Turbuhaler®
Budesonide and formoterol fumarate inhalation powder (Symbicort® Turbuhaler®), 160 μg/4.5 μg per inhalation. Administered as 2 inhalations twice daily for 28 days.
Placebo for CP006 Inhalation PowderDrug
Placebo matching CP006 Inhalation Powder. Contains no active pharmaceutical ingredients. Administered as 1 inhalation twice daily for 28 days to maintain blinding.
Placebo for Budesonide and Formoterol FumarateDrug
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.
Albuterol SulfateDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Budesonide and Formoterol Fumarate; Drug: Placebo for CP006 Inhalation Powder; Drug: Albuterol Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline (Day 0) and Day 29
Secondary outcomes (11)
Change from Baseline in Morning Pre-dose Trough FEV₁ at Day 8 and Day 15
Forced expiratory volume in one second (FEV₁) measured before the morning dose of study medication at Day 8 and Day 15. Change from baseline is calculated as the value at each time point minus the baseline value (measured at Day 0 before the first dose).
Measured: 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
Peak expiratory flow (PEF) measured by a handheld peak flow meter before the morning and evening doses of study medication. The mean PEF value over the 7 days prior to each visit is calculated. Change from baseline is calculated as the mean value at each time point minus the baseline mean value (measured during the 7 days prior to randomization).
Measured: 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
PEF diurnal variability is calculated as 2 × (highest PEF in a day - lowest PEF in a day) / (highest PEF in a day + lowest PEF in a day) × 100%. The mean daily PEF diurnal variability over 7 days at Week 4 is compared to baseline (the 7 days prior to randomization).
Measured: 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
The AQLQ consists of 32 items covering symptoms, activity limitation, emotional function, and environmental stimuli. Each item is scored on a 7-point scale (1 = severely impaired, 7 = not impaired at all). The total score is the mean of all item scores. Change from baseline is calculated as the score at each time point minus the baseline score (measured at Day 0 before the first dose).
Measured: 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
The ACQ-5 consists of 5 questions assessing asthma symptoms, rescue medication use, and impact on daily activities over the past week. Each item is scored on a 0-6 scale. The total score is the mean of all item scores. Change from baseline is calculated as the score at each time point minus the baseline score (measured at Day 0 before the first dose).
Measured: Baseline (Day 0), Day 8, Day 15, and Day 29
Total Number of Actuations of Rescue Medication Used During the Treatment Period
Total actuations of albuterol sulfate inhalation aerosol (100 µg per actuation) used on an as-needed basis for asthma symptoms during the 28-day treatment period.
Measured: Day 1 through Day 28
Total Number of Days with Rescue Medication Use During the Treatment Period
Number of days on which albuterol sulfate inhalation aerosol was used at least once during the 28-day treatment period.
Measured: Day 1 through Day 28
Percentage of Days with No Rescue Medication Use During the Treatment Period
Percentage of days during the 28-day treatment period on which no albuterol sulfate inhalation aerosol was used, calculated as (number of days with no rescue medication use / total days in the treatment period) × 100%.
Measured: Day 1 through Day 28
Time to First Asthma Exacerbation During the Treatment Period
Time from randomization (Day 0) to the first occurrence of an asthma exacerbation, measured in days.
Measured: Day 0 through Day 28
Number of Participants with Moderate Asthma Exacerbations
Number of participants who experienced at least one moderate asthma exacerbation during the 28-day treatment period.
Measured: Day 1 through Day 28
Number of Participants with Severe Asthma Exacerbations
Number of participants who experienced at least one severe asthma exacerbation during the 28-day treatment period.
Measured: Day 1 through Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start21 Nov 2025
- Primary completion3 Aug 2026
- Study completion17 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Xin Huanghe Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807007
- Sponsor's protocol ID
- SHXHH-CP006-CT-A01
- Other IDs
- CTR20254001
- Acronym
- CP006-ASTHMA
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. The informed consent obtained from participants in this study did not include provisions for the sharing of individual participant data with third parties or for the transfer of data outside of China. Sharing IPD would therefore be inconsistent with the scope of the consent provided by participants and with applicable data protection requirements. Requests for the study protocol and statistical analysis plan may be directed to the sponsor at clinicalmedicine@chenpon.com and will be considered on a case-by-case basis.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07807007
- Acronym / sponsor ID
- CP006-ASTHMA / SHXHH-CP006-CT-A01
- Conditions
- Asthma
- Keywords
- Asthma, Budesonide, Formoterol, Umeclidinium, Inhalation Powder, Triple Therapy, Phase II
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Shanghai Xin Huanghe Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Nov 2025 (actual)
- Primary completion
- 3 Aug 2026 (actual)
- Study completion
- 17 Aug 2026 (actual)
- First posted
- 8 Sep 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| CP006 Dose 1 (BUD/FORM/UMEC 390/11/55 μg/day) | Experimental | Drug: Budesonide, Formoterol Fumarate, and Umeclidinium Bromide, Drug: Placebo for Budesonide and Formoterol Fumarate, Drug: Albuterol SulfateParticipants 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. |
| CP006 Dose 2 (BUD/FORM/UMEC 390/11/27.5 μg/day) | Experimental | Drug: Budesonide, Formoterol Fumarate, and Umeclidinium Bromide, Drug: Placebo for Budesonide and Formoterol Fumarate, Drug: Albuterol SulfateParticipants 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. |
| Active Comparator (BUD/FORM 640/18 μg/day) | Active comparator | Drug: Budesonide and Formoterol Fumarate, Drug: Placebo for CP006 Inhalation Powder, Drug: Albuterol SulfateParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
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 |
|---|---|---|
| Budesonide, Formoterol Fumarate, and Umeclidinium BromideAlso: CP006 Inhalation Powder (High Dose: 195/5.5/27.5 µg)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. | Drug | CP006 Dose 1 (BUD/FORM/UMEC 390/11/55 μg/day) |
| Budesonide, Formoterol Fumarate, and Umeclidinium BromideAlso: CP006 Inhalation Powder (Low Dose: 195/5.5/13.8 µg)CP006 Inhalation Powder, 195 μg/5.5 μg/13.8 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 13.8 μg) per inhalation. | Drug | CP006 Dose 2 (BUD/FORM/UMEC 390/11/27.5 μg/day) |
| Budesonide and Formoterol FumarateAlso: Symbicort® Turbuhaler®Budesonide and formoterol fumarate inhalation powder (Symbicort® Turbuhaler®), 160 μg/4.5 μg per inhalation. Administered as 2 inhalations twice daily for 28 days. | Drug | Active Comparator (BUD/FORM 640/18 μg/day) |
| Placebo for CP006 Inhalation PowderPlacebo matching CP006 Inhalation Powder. Contains no active pharmaceutical ingredients. Administered as 1 inhalation twice daily for 28 days to maintain blinding. | Drug | Active Comparator (BUD/FORM 640/18 μg/day) |
| Placebo for Budesonide and Formoterol FumaratePlacebo 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. | Drug | CP006 Dose 1 (BUD/FORM/UMEC 390/11/55 μg/day), CP006 Dose 2 (BUD/FORM/UMEC 390/11/27.5 μg/day) |
| Albuterol SulfateAlbuterol 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. | Drug | 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) |
Primary outcome
Change from Baseline in Morning Pre-dose Trough FEV₁ at Day 29
Time frame: Baseline (Day 0) and 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).
11 secondary outcomes
Change from Baseline in Morning Pre-dose Trough FEV₁ at Day 8 and Day 15
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline (Day 0), Day 8, Day 15, and Day 29
Total Number of Actuations of Rescue Medication Used During the Treatment Period
Time frame: Day 1 through Day 28
Total Number of Days with Rescue Medication Use During the Treatment Period
Time frame: Day 1 through Day 28
Percentage of Days with No Rescue Medication Use During the Treatment Period
Time frame: Day 1 through Day 28
Time to First Asthma Exacerbation During the Treatment Period
Time frame: Day 0 through Day 28
Number of Participants with Moderate Asthma Exacerbations
Time frame: Day 1 through Day 28
Number of Participants with Severe Asthma Exacerbations
Time frame: Day 1 through Day 28
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 8 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. The informed consent obtained from participants in this study did not include provisions for the sharing of individual participant data with third parties or for the transfer of data outside of China. Sharing IPD would therefore be inconsistent with the scope of the consent provided by participants and with applicable data protection requirements. Requests for the study protocol and statistical analysis plan may be directed to the sponsor at clinicalmedicine@chenpon.com and will be considered on a case-by-case basis.
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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.
13 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 Budesonide, Formoterol Fumarate, and Umeclidinium Bromide, Budesonide and Formoterol Fumarate and Albuterol Sulfate in people with Asthma, run by Shanghai Xin Huanghe Pharmaceutical Co., Ltd. at 13 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 8 inclusion and 24 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 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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. 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?
Change from Baseline in Morning Pre-dose Trough FEV₁ at Day 29 (time frame: Baseline (Day 0) and Day 29). 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 8 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.