A Phase 3 interventional study of Budesonide and Formoterol Fumarate and Placebo of Budesonide and Formoterol Fumarate in Asthma, sponsored by Shanghai Xin Huanghe Pharmaceutical Co., Ltd.. Completed at 28 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Shanghai Xin Huanghe Pharmaceutical Co., Ltd. (part of Chenpon Pharmaceutical) · Phase 3, Interventional, and Treatment
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Among 110 studies testing budesonide in Asthma — 6 open to participants now, 6 under way, 3 of them phase 3. Budesonide · Asthma.
Among the 110 studies testing budesonide in Asthma, this one is the 35th largest by enrollment of the 108 interventional ones that give a count, is one of 3 that started in 2024, is one of 51 in phase 3, and was the 110th registered.
4,846 studies on the registry are indexed under Asthma; 603 are open to participants now.
Browse Asthma studies →6 of the 110 studies testing budesonide in Asthma are open now, in 5 countries. Recruiting first, the newest first:
University of Miami · Sites in United States
Ages 18–75
Massachusetts General Hospital · Sites in United States
Ages 18–54
University of KwaZulu · Sites in South Africa
Ages 6–18
Franciscus Gasthuis · Sites in Netherlands
Ages 18+
University of British Columbia · Sites in Canada
Ages 19–49
By country, each count listing its studies:
Budesonide: first FDA approval 1994 (RHINOCORT), first EMA approval 2014. What it is approved for, and how studies give it, is on its page →
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.
110 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 11 · Phase 2 6 · Phase 3 51 · Phase 4 33
First in 1991; this study’s year is marked. 3 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 338 is above the median of 79 across 3,344 interventional studies indexed under Asthma.
Median enrollment 124 across the 108 interventional studies. Of the 94 that completed or were terminated, 35 (37%) have results posted.
This tab as a report to print or save as PDF → With an account.
64 of 110 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.
1 of the studies testing budesonide in Asthma that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07166939Massachusetts General Hospital45th Multicenter Airway Research Collaboration | 2027-06 |
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Among the 110 studies testing budesonide in Asthma, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The goal of this clinical trial is to evaluate whether budesonide/formoterol powder for inhalation (II) manufactured by Shanghai New Huanghe Pharmaceutical Co., Ltd. is non-inferior to the active comparator, Symbicort® Turbuhaler® (AstraZeneca), in the treatment of adult bronchial asthma, and to assess its safety profile in this population.
The main questions it aims to answer are:
Does the test product (budesonide/formoterol 160 μg/4.5 μg) show non-inferior efficacy compared to the reference product (Symbicort® Turbuhaler® 160 μg/4.5 μg) in improving lung function, as measured by the change from baseline in trough FEV1 after 42 days of treatment?
What is the safety profile of the test product in adult patients with asthma?
Researchers will compare participants receiving the test product plus placebo of the comparator to those receiving the active comparator plus placebo of the test product, to see if the test product is non-inferior to the reference product in terms of efficacy, with comparable safety.
Participants will:
Be randomized to receive either the test product (budesonide/formoterol 160 μg/4.5 μg, 2 inhalations twice daily) plus placebo of the comparator, or the active comparator (Symbicort® Turbuhaler® 160 μg/4.5 μg, 2 inhalations twice daily) plus placebo of the test product, for 6 weeks of treatment
Perform daily morning and evening PEF measurements and record them, along with rescue medication use and any adverse events, in a diary card
Attend regular clinic visits for pulmonary function tests, ACQ-5 and AQLQ questionnaires, safety assessments (vital signs, physical and oropharyngeal examinations, laboratory tests, and 12-lead ECG), and drug accountability
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.
Positive result from any objective test for variable airflow limitation, either:
Exclusion Criteria:
Concurrent severe cardiovascular disease, including but not limited to:
Abnormal liver or kidney function, defined as:
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.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
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.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
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 will receive one inhalation of the test product, Budesonide/Formoterol Powder for Inhalation (II) 160 μg/4.5 μg (2 inhalations), twice daily, followed by one inhalation of the placebo matching the comparator (Symbicort® Turbuhaler®), twice daily, for 6 weeks.
Drug: Budesonide and Formoterol Fumarate · Drug: Placebo of Budesonide and Formoterol Fumarate
Participants will receive one inhalation of the active comparator, Symbicort® Turbuhaler® (budesonide/formoterol 160 μg/4.5 μg, 2 inhalations), twice daily, followed by one inhalation of the placebo matching the test product, twice daily, for 6 weeks.
Drug: Placebo of Budesonide and Formoterol Fumarate · Drug: Budesonide and Formoterol Fumarate
Drug pages: Budesonide · Formoterol
Budesonide/formoterol 160 μg/4.5 μg per inhalation, administered as 2 inhalations twice daily via the Pingchuan® dry powder inhaler.
Placebo matching the test product, containing inactive excipients only, administered as 2 inhalations twice daily via the Pingchuan® dry powder inhaler.
Drug pages: Budesonide · Formoterol
Active comparator: Symbicort® Turbuhaler® (budesonide/formoterol 160 μg/4.5 μg per inhalation), administered as 2 inhalations twice daily via the Turbuhaler® dry powder inhaler. Manufactured by AstraZeneca.
Placebo matching the active comparator (Symbicort® Turbuhaler®), containing inactive excipients only, administered as 2 inhalations twice daily via the Turbuhaler® dry powder inhaler.
Change from baseline in trough FEV1 after 42 days of treatment
Trough FEV1 (forced expiratory volume in 1 second) measured before morning dosing at Day 43 (after 42 days of treatment). Change from baseline calculated as post-treatment value minus baseline value, where baseline is the pre-dose FEV1 measured on Day 1 before the first dose of study drug.
Time frame: Baseline (Day 1 pre-dose) to Day 43
FEV1 AUC0-12h on Day 1
Area under the curve for FEV1 from 0 to 12 hours after the first dose of study drug on Day 1.
Time frame: Day 1 (0 to 12 hours post-dose)
Change from baseline in trough FEV1 at Day 15 and Day 29
Trough FEV1 measured before morning dosing at Day 15 and Day 29. Change from baseline calculated as post-treatment value minus baseline value.
Time frame: Baseline (Day 1 pre-dose) to Day 15, Day 29
Change from baseline in FVC at Day 15, Day 29, and Day 43
FVC (forced vital capacity) measured pre-dose at each visit. Change from baseline calculated as post-treatment value minus baseline value.
Time frame: Baseline (Day 1 pre-dose) to Day 15, Day 29, Day 43
Change from baseline in morning PEF
Morning PEF (peak expiratory flow) measured pre-dose daily. Change from baseline is the mean morning PEF during each treatment week minus the mean morning PEF during the 7-day run-in period.
Time frame: Baseline (7-day run-in period) to weekly through Day 43
Change from baseline in PEF diurnal variability at Day 43
PEF diurnal variability calculated as 2 × (daily max PEF - daily min PEF) / (daily max PEF + daily min PEF) × 100%. Change from baseline is the mean of 7 days at Day 43 minus the mean of 7 days at baseline.
Time frame: Baseline (7-day run-in period) to Day 43
Change from baseline in ACQ-5 score at Day 15, Day 29, and Day 43
ACQ-5 (Asthma Control Questionnaire-5) score ranges from 0 to 6, with higher scores indicating poorer asthma control. Change from baseline is score at visit minus baseline score.
Time frame: Baseline (Day 0 pre-randomization) to Day 15, Day 29, Day 43
Change from baseline in AQLQ score at Day 15, Day 29, and Day 43
AQLQ (Asthma Quality of Life Questionnaire) score ranges from 1 to 7, with higher scores indicating better quality of life. Total score is the mean of all 32 items. Change from baseline is score at visit minus baseline score.
Time frame: Baseline (Day 0 pre-randomization) to Day 15, Day 29, Day 43
Percentage of rescue medication-free days during treatment
Percentage of days during the 6-week treatment period on which no rescue medication (salbutamol) was used.
Time frame: Day 1 through Day 43
Number of rescue medication uses during treatment
Total number of inhalations of rescue medication (salbutamol) used during the 6-week treatment period.
Time frame: Day 1 through Day 43
Asthma exacerbations during treatment
Number, severity, time to first occurrence, and annualized rate of asthma exacerbations (mild, moderate, and severe) during the treatment period.
Time frame: Day 1 through Day 43
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 Feb 2024 to primary completion in Sep 2024, 7 months.
Of 173 industry-sponsored phase 3 interventional studies under Asthma, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 41. This study's 7 months is below that.
Counting every sponsor, half of 205 studies reached it within 27 months; a quarter within 14 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Budesonide · Formoterol