Can a Three-Drug inhaler outperform the standard Two-Drug treatment for asthma?
NCT ID NCT07807007
First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time
Summary
This trial tests whether CP006, an investigational inhaler combining three medications (budesonide, formoterol, and umeclidinium), improves lung function in adults with asthma better than a standard two-drug inhaler. Participants take either a high or low dose of CP006 or the comparator twice daily for 28 days. Researchers measure changes in breathing capacity and track any side effects. The study aims to see if the triple combination offers better asthma control than current therapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CP006 Inhalation Powder, a triple combination of budesonide, formoterol, and umeclidinium
- What this could lead to
- If CP006 works, it could offer a more effective once-a-day option for people whose asthma is not well controlled with standard two-drug inhalers.
- What could go wrong
- This is an early phase II study with a small number of participants, so the drug may not prove more effective or safe than existing treatments. Possible side effects are not yet fully known.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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150 people
The number who actually took part.
- Started
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Nov 2025
- Finished
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Aug 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Chongqing Fuling Central Hospital
Chongqing, Chongqing Municipality, 408099, China
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Gansu Provincial Hospital
Lanzhou, Gansu, 730000, China
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Hefei First People's Hospital
Hefei, Anhui, 230061, China
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Huai'an First People's Hospital
Huai'an, Jiangsu, 223300, China
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Lianyungang First People's Hospital
Lianyungang, Jiangsu, 222002, China
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Mianyang Central Hospital
Mianyang, Sichuan, 621099, China
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Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
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Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433, China
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The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453100, China
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The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050031, China
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The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004, China
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Yan'an University Xianyang Hospital
Xianyang, Shaanxi, 712000, China
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Zhongjiang People's Hospital
Kaijiang, Sichuan, 618100, China
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