A Phase 1 interventional study of Budesonide and Formoterol Fumarate Powder for Inhalation (II) (Test) and Budesonide and Formoterol Fumarate Powder for Inhalation (II) (Reference) in Asthma and Chronic Obstructive Pulmonary Disease (COPD), sponsored by Shanghai Xin Huanghe Pharmaceutical Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Shanghai Xin Huanghe Pharmaceutical Co., Ltd. (part of Chenpon Pharmaceutical) · Phase 1, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
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 165th largest by enrollment of the 182 interventional ones that give a count, is one of 38 that started in 2024, is one of 31 in phase 1, 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 45 Years · all sexes · healthy volunteers too.
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. 38 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 30 is below 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 study is to learn if a new formulation of Budesonide/Formoterol Inhalation Powder (160μg/4.5μg), manufactured by Shanghai New Huanghe Pharmaceutical Co., Ltd., works the same as the already approved reference product, Symbicort® Turbuhaler® (160μg/4.5μg), in the body. It will also learn about the safety of the new formulation.
The main questions it aims to answer are:
Researchers will compare the new formulation to the reference product (the already approved treatment) to see if they are bioequivalent.
Participants will:
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.
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.
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.
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.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
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.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
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.
Participants in this arm will receive a single dose of the Test Formulation (Budesonide and Formoterol Fumarate Powder for Inhalation (II), 160 μg/4.5 μg) in Period 1, followed by a single dose of the Reference Formulation (Symbicort® Turbuhaler®, 160 μg/4.5 μg) in Period 2, with a 4-day washout period between doses.
Drug: Budesonide and Formoterol Fumarate Powder for Inhalation (II) (Test) · Drug: Budesonide and Formoterol Fumarate Powder for Inhalation (II) (Reference)
Participants in this arm will receive a single dose of the Reference Formulation (Symbicort® Turbuhaler®, 160 μg/4.5 μg) in Period 1, followed by a single dose of the Test Formulation (Budesonide and Formoterol Fumarate Powder for Inhalation (II), 160 μg/4.5 μg) in Period 2, with a 4-day washout period between doses.
Drug: Budesonide and Formoterol Fumarate Powder for Inhalation (II) (Test) · Drug: Budesonide and Formoterol Fumarate Powder for Inhalation (II) (Reference)
160 μg/4.5 μg, administered as 2 inhalations, manufactured by Shanghai New Huanghe Pharmaceutical Co., Ltd.
Also known as: Pingchuan®
Drug page: Budesonide/Formoterol Fumarate Dihydrate Inhalation Aerosol
160 μg/4.5 μg, administered as 2 inhalations, manufactured by AstraZeneca AB.
Also known as: Symbicort® Turbuhaler®
Maximum Observed Concentration (Cmax)
Cmax is the peak plasma concentration of budesonide and formoterol, obtained directly from the plasma concentration-time data.
Time frame: 0 to 36 hours post-dose in each period
Area Under the Plasma Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUC0-t)
AUC0-t is calculated using the linear trapezoidal rule from time 0 to the time of the last measurable concentration.
Time frame: 0 to 36 hours post-dose in each period
Area Under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-∞)
AUC0-∞ is calculated as AUC0-t + Ct/λz, where Ct is the last measurable concentration and λz is the terminal elimination rate constant.
Time frame: 0 to 36 hours post-dose in each period
Time to Maximum Observed Concentration (Tmax)
Tmax is the time to reach peak plasma concentration, obtained directly from the plasma concentration-time data.
Time frame: 0 to 36 hours post-dose in each period
Terminal Elimination Rate Constant (λz)
λz is the terminal elimination rate constant, calculated using linear regression of the terminal phase of the semi-logarithmic concentration-time curve.
Time frame: 0 to 36 hours post-dose in each period
Terminal Elimination Half-Life (t1/2)
t1/2 is the terminal elimination half-life, calculated as ln2/λz.
Time frame: 0 to 36 hours post-dose in each period
Percentage of AUC0-∞ Extrapolated (AUC_%Extrap)
AUC\_%Extrap is calculated as \[(AUC0-∞ - AUC0-t) / AUC0-∞\] × 100%.
Time frame: 0 to 36 hours post-dose in each period
Number of Participants with Adverse Events (AEs)
Adverse events are recorded and graded according to NCI-CTCAE version 5.0.
Time frame: From first dose administration until follow-up visit (approximately 3 days after the last dose in Period II)
Number of Participants with Serious Adverse Events (SAEs)
Serious adverse events are recorded according to NCI-CTCAE version 5.0 criteria.
Time frame: From first dose administration until follow-up visit (approximately 3 days after the last dose in Period II)
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 Jan 2024 to primary completion in Jan 2024, 0 months.
Of 173 industry-sponsored phase 1 interventional studies under Asthma, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 12. This study's 0 months is below that.
Counting every sponsor, half of 200 studies reached it within 6 months; a quarter within 3 and three quarters within 14.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Budesonide/Formoterol Fumarate Dihydrate Inhalation Aerosol