A Phase 2 interventional study of Budesonide, Formoterol Fumarate, and Umeclidinium Bromide and Budesonide, Formoterol Fumarate, and Umeclidinium Bromide in Asthma, sponsored by Shanghai Xin Huanghe Pharmaceutical Co., Ltd.. Completed at 13 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Shanghai Xin Huanghe Pharmaceutical Co., Ltd. (part of Chenpon Pharmaceutical) · Phase 2, Interventional, and Treatment
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Among 251 studies in Asthma with a site in China — 87 open to participants now, 96 under way, 15 of them phase 3. Asthma · China.
Among the 251 studies in Asthma with a site in China, this one is the 110th largest by enrollment of the 182 interventional ones that give a count, is one of 32 that started in 2025, is one of 39 in phase 2, and was the 247th registered.
4,846 studies on the registry are indexed under Asthma; 603 are open to participants now.
Browse Asthma studies →87 of the 251 studies in Asthma with a site in China are open now. Recruiting first, the newest first:
Janssen Research & Development, LLC · Sites in China, United States, Argentina and 2 more countries
Ages 18–85
AstraZeneca · Sites in China
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Sites in China
Ages 18–70
Shanghai Pulmonary Hospital, Shanghai, China · Sites in China
Ages 18+
Chiesi Farmaceutici S.p.A. · Sites in China
Ages 18–75
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 417 Asthma studies recruiting now, 140 (34%) set no upper age limit and 205 (49%) stop at 75 or younger; 147 take children under 18; 105 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
251 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 35 · Phase 2 46 · Phase 3 50 · Phase 4 18
First in 1998; this study’s year is marked. 32 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 150 is above the median of 79 across 3,344 interventional studies indexed under Asthma.
Median enrollment 203 across the 182 interventional studies, 407 across the 69 observational. Of the 116 that completed or were terminated, 30 (26%) have results posted.
This tab as a report to print or save as PDF → With an account.
140 of 251 have an industry lead sponsor. The 10 most frequent:
This study is registered under Shanghai Xin Huanghe Pharmaceutical Co., Ltd., one of the names counted as Chenpon Pharmaceutical. Under that name alone:
Shanghai Xin Huanghe Pharmaceutical Co., Ltd. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Chenpon Pharmaceutical has 3 studies filed under Asthma — fewer than ten, so there is no comparison to draw.
28 of the studies in Asthma with a site in China that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06323213Phase 3Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Efficacy and Safety Study of 610 in Patients With Severe Asthma | 2027-02 |
| NCT06895460Phase 3The First Affiliated Hospital with Nanjing Medical UniversityA Trial on the Treatment of Bronchial Asthma With Budesonide Formoterol Combined With Immune Modulators (Staphylococcus and Neisseria Tablets) | 2027-06-30 |
| NCT06653322Phase 3Guangdong Hengrui Pharmaceutical Co., LtdA Multi-centered，Randomized，Double-blind，Placebo-controlled Study to Evaluate the Efficacy and Safety of SHR-1703 in Eosinophilic Asthma | 2027-09 |
| NCT06471257Phase 3AstraZenecaA Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma | 2027-10-04 |
| NCT06307665Phase 3AstraZenecaEvaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma | 2027-10-13 |
Add all 28 to your calendar (.ics) → With an account.
Among the 251 studies in Asthma with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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 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.
Also known as: CP006 Inhalation Powder (Low Dose: 195/5.5/13.8 µg)
Drug pages: Budesonide · Formoterol
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®
Placebo matching CP006 Inhalation Powder. Contains no active pharmaceutical ingredients. Administered as 1 inhalation twice daily for 28 days to maintain blinding.
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 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.
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).
Time frame: Baseline (Day 0) and Day 29
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).
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
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).
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
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).
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
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).
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
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).
Time frame: 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.
Time frame: 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.
Time frame: 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%.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1 through Day 28
Plan to share: 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.
No publications or documents are linked to this record.
Ran from Nov 2025 to primary completion in Aug 2026, 8 months.
Of 137 industry-sponsored phase 2 interventional studies under Asthma, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 23. This study's 8 months is below that.
Counting every sponsor, half of 199 studies reached it within 20 months; a quarter within 12 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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