Preserved Ratio Impaired Spirometry (PRISM)BGF-PRISmNCT07595796

An Exploratory Study on Triple Inhaler Therapy in Patients With Early Lung Function Impairment

A study testing Budesonide/glycopyrronium bromide/formoterol inhalation aerosol in people with Preserved Ratio Impaired Spirometry (PRISM), run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

Who is it for?: Ages 40 to 75 years
Conditions the study is for: Preserved Ratio Impaired Spirometry (PRISM)
What is being tested?: Budesonide/glycopyrronium bromide/formoterol inhalation aerosol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: No sites listed yet
Study dates: 1 Jun 2026to 29 Feb 2028
Phase: Interventional
Are there results?: Not yet: the study is under way

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 40 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 40-75 years;
Smoking history ≥10 pack-years;
Pulmonary function test showing 0.7 ≤ FEV1/FVC < 0.8 and FEV1 < 80% predicted;
Presence of at least one chronic respiratory symptom (e.g., cough, sputum, dyspnea) lasting ≥3 months;
Voluntarily sign a written informed consent form, be able to understand the study objectives, and comply with follow-up requirements;
The investigator assesses that the subject is able to complete the 12-week treatment and follow-up and has good medication adherence.

Who cannot join

Concomitant Respiratory Diseases: (1) Diagnosed asthma, bronchiectasis, interstitial lung disease, active tuberculosis, or lung cancer. (2) Meeting the diagnostic criteria for chronic obstructive pulmonary disease (COPD) (post-bronchodilator FEV1/FVC < 0.7). (3) Acute respiratory infection or exacerbation within 4 weeks prior to enrollment.
Cardiovascular Disease Risks: (1) Uncontrolled hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg). (2) Myocardial infarction, unstable angina, malignant arrhythmia, or cardiac insufficiency (NYHA class ≥III) within the past 6 months. (3) Long-term use of beta-blockers or antiarrhythmic drugs.
Drug-Related Contraindications: (1) Allergy to budesonide, glycopyrronium bromide, formoterol, or excipients of the inhalation aerosol. (2) Use of long-acting bronchodilators (LABA, LAMA), inhaled corticosteroids, or immunosuppressants within 4 weeks prior to enrollment.
Other Systemic Diseases: (1) Severe hepatic or renal insufficiency (ALT/AST > 3 times the upper limit of normal, or eGFR < 30 mL/min/1.73m²). (2) Uncontrolled diabetes (HbA1c > 9%) or hyperthyroidism.
Special Populations and Compliance Issues: (1) Pregnant or lactating women, or women planning pregnancy without using effective contraception. (2) History of substance abuse, psychiatric disorders, or cognitive impairment that may affect study compliance. (3) The investigator deems the subject unsuitable for participation for other reasons (e.g., life expectancy < 1 year, inability to complete follow-up).

About this study

Official title: Efficacy Evaluation of Budesonide/Glycopyrronium Bromide/Formoterol Inhalation Aerosol in Symptomatic Preserved Ratio Impaired Spirometry (PRISm): A Single-arm Multicenter Clinical Trial

Preserved Ratio Impaired Spirometry (PRISm) is characterized by a normal forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio but an FEV1 below 80% of the predicted value. It has a population prevalence of approximately 10% and is associated with marked symptoms, a high risk of acute exacerbations, and increased mortality. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) defines PRISm as a pre-chronic obstructive pulmonary disease (COPD) state, and 20%-30% of patients with PRISm will progress to COPD. Currently, no evidence-based therapy exists for PRISm; management is mainly symptomatic relief, and there is an urgent need for evidence-based support. This single-arm clinical trial preliminarily evaluates the efficacy and safety of budesonide/glycopyrronium/formoterol inhalation aerosol in symptomatic patients with PRISm. Symptomatic smokers who meet the diagnostic criteria for PRISm and have an FEV1/FVC ratio ≥0.7 and <0.8 are enrolled and treated with budesonide/glycopyrronium/formoterol inhalation therapy for 12 weeks. The primary endpoint is the change from baseline in FEV1; secondary endpoints include symptom score (COPD Assessment Test, CAT) and quality of life (St George's Respiratory Questionnaire, SGRQ); safety is assessed by recording adverse events (e.g., cardiovascular events); and exploratory analyses examine the association between biomarkers (e.g., peripheral blood eosinophil count, serum IgE level) and treatment efficacy. The study aims to preliminarily explore the efficacy and safety of budesonide/glycopyrronium/formoterol inhaler therapy for PRISm. Early intervention may delay the progression from PRISm to COPD, reduce the burden of chronic respiratory disease, and have important clinical translational value and public health significance.

Conditions: Preserved Ratio Impaired Spirometry (PRISM)
Being tested: Budesonide/glycopyrronium bromide/formoterol inhalation aerosol
Keywords: Preserved Ratio Impaired Spirometry (PRISM)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Budesonide/glycopyrronium bromide/formoterol inhalation aerosolDrug
Budesonide/glycopyrronium/formoterol inhalation aerosol delivers budesonide (160 μg), glycopyrronium (7.2 μg), and formoterol (4.8 μg) per actuation. It is administered as two inhalations twice daily (two in the morning and two in the evening), approximately 12 hours apart, via a pressurized metered-dose inhaler (pMDI). Subjects are required to receive standardized training on inhalation technique to ensure proper technique.

Study groups in NCT07595796
Study group	Role	What they receive
Budesonide/Glycopyrronium Bromide/Formoterol	Experimental	budesonide/glycopyrronium bromide/formoterol inhalation aerosol Receives: Drug: Budesonide/glycopyrronium bromide/formoterol inhalation aerosol

What is being measured

The primary outcome is the main question the study is designed to answer.

Trough forced expiratory volume in the first second (trough FEV1)
Pulmonary function tests will be conducted using standardized spirometry (in accordance with ATS/ERS guidelines) at 12 hours post-dose (trough state).
Measured: Baseline, Week 6, and Week 12

Secondary outcomes (3)

Saint George's Respiratory Questionnaire (SGRQ) Score
The standardized SGRQ (Chinese version) will be self-administered by the subjects.
Measured: Baseline, Week 6, and Week 12
COPD Assessment Test (CAT) Score
The standardized CAT questionnaire (Chinese version) will be self-administered by the subjects.
Measured: Baseline, Week 6, and Week 12
Adverse events (AEs) and serious adverse events (SAEs)
All AE/SAE occurrences and types during the treatment period will be recorded. Grading will be performed according to the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Causality and severity will be assessed by the investigator.
Measured: Baseline, Week 6, and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202629 Feb 2028

First posted19 May 2026
Study start1 Jun 2026 (estimated)
Primary completion29 Feb 2028 (estimated)
Study completion29 Feb 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Preserved Ratio Impaired Spirometry (PRISM)Studies of the same condition, open and under way.
More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 23 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07595796
Sponsor's protocol ID: SYSKY-2026-195-02
Acronym: BGF-PRISm
Status last verified: May 2026
First submitted: 13 May 2026
Last updated: 19 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Comparison of Clinical Status of Individuals With COPD and Preserved Ratio Impaired Spirometry
Chronic Obstructive Pulmonary Disease (COPD), Preserved Ratio Impaired Spirometry (PRISM)
Recruiting
Role of Exercise in PRISm and Subsequent Development of COPD
Preserved Ratio Impaired Spirometry (PRISM)
Not yet recruitingObservational study
Mitigating Chronic Respiratory Disease Through the Lens of Multimorbidity (MARES3)
Chronic Obstructive Pulmonary Disease (COPD), Asthma
Not yet recruitingObservational study
Respiratory Disease Cohort Studies of Chinese Medicine for COPD(RESEARCH-COPD)
Chronic Obstructive Pulmoriary Disease (COPD), Preserved Ratio Impaired Spirometry (PRISM)

All Preserved Ratio Impaired Spirometry (PRISM) trials

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy Evaluation of Budesonide/Glycopyrronium Bromide/Formoterol Inhalation Aerosol in Symptomatic Preserved Ratio Impaired Spirometry (PRISm): A Single-arm Multicenter Clinical Trial
ClinicalTrials.gov ID: NCT07595796
Acronym / sponsor ID: BGF-PRISm / SYSKY-2026-195-02
Conditions: Preserved Ratio Impaired Spirometry (PRISM)
Keywords: Preserved Ratio Impaired Spirometry (PRISM)
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 23 participants (estimated)
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
Study start: 1 Jun 2026 (estimated)
Primary completion: 29 Feb 2028 (estimated)
Study completion: 29 Feb 2028 (estimated)
First posted: 19 May 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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Budesonide/Glycopyrronium Bromide/Formoterol	Experimental	Drug: Budesonide/glycopyrronium bromide/formoterol inhalation aerosolbudesonide/glycopyrronium bromide/formoterol inhalation aerosol

Who may qualify

Ages: 40 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Age 40-75 years;
Smoking history ≥10 pack-years;
Pulmonary function test showing 0.7 ≤ FEV1/FVC < 0.8 and FEV1 < 80% predicted;
Presence of at least one chronic respiratory symptom (e.g., cough, sputum, dyspnea) lasting ≥3 months;
Voluntarily sign a written informed consent form, be able to understand the study objectives, and comply with follow-up requirements;

Key exclusion criteria (5 listed)

Concomitant Respiratory Diseases: (1) Diagnosed asthma, bronchiectasis, interstitial lung disease, active tuberculosis, or lung cancer. (2) Meeting the diagnostic criteria for chronic obstructive pulmonary disease (COPD) (post-bronchodilator FEV1/FVC < 0.7). (3) Acute respiratory infection or exacerbation within 4 weeks prior to enrollment.
Cardiovascular Disease Risks: (1) Uncontrolled hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg). (2) Myocardial infarction, unstable angina, malignant arrhythmia, or cardiac insufficiency (NYHA class ≥III) within the past 6 months. (3) Long-term use of beta-blockers or antiarrhythmic drugs.
Drug-Related Contraindications: (1) Allergy to budesonide, glycopyrronium bromide, formoterol, or excipients of the inhalation aerosol. (2) Use of long-acting bronchodilators (LABA, LAMA), inhaled corticosteroids, or immunosuppressants within 4 weeks prior to enrollment.
Other Systemic Diseases: (1) Severe hepatic or renal insufficiency (ALT/AST > 3 times the upper limit of normal, or eGFR < 30 mL/min/1.73m²). (2) Uncontrolled diabetes (HbA1c > 9%) or hyperthyroidism.
Special Populations and Compliance Issues: (1) Pregnant or lactating women, or women planning pregnancy without using effective contraception. (2) History of substance abuse, psychiatric disorders, or cognitive impairment that may affect study compliance. (3) The investigator deems the subject unsuitable for participation for other reasons (e.g., life expectancy < 1 year, inability to complete follow-up).

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/glycopyrronium bromide/formoterol inhalation aerosolBudesonide/glycopyrronium/formoterol inhalation aerosol delivers budesonide (160 μg), glycopyrronium (7.2 μg), and formoterol (4.8 μg) per actuation. It is administered as two inhalations twice daily (two in the morning and two in the evening), approximately 12 hours apart, via a pressurized metered-dose inhaler (pMDI). Subjects are required to receive standardized training on inhalation technique to ensure proper technique.	Drug	Budesonide/Glycopyrronium Bromide/Formoterol

Primary outcome

Trough forced expiratory volume in the first second (trough FEV1)
Time frame: Baseline, Week 6, and Week 12
Pulmonary function tests will be conducted using standardized spirometry (in accordance with ATS/ERS guidelines) at 12 hours post-dose (trough state).

3 secondary outcomes

Saint George's Respiratory Questionnaire (SGRQ) Score
Time frame: Baseline, Week 6, and Week 12
COPD Assessment Test (CAT) Score
Time frame: Baseline, Week 6, and Week 12
Adverse events (AEs) and serious adverse events (SAEs)
Time frame: Baseline, Week 6, and Week 12

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
Individual participant dataSharing planned: No

Related trials for Preserved Ratio Impaired Spirometry (PRISM)

RecruitingObservational study
Comparison of Clinical Status of Individuals With COPD and Preserved Ratio Impaired Spirometry
Chronic Obstructive Pulmonary Disease (COPD), Preserved Ratio Impaired Spirometry (PRISM)
Recruiting
Role of Exercise in PRISm and Subsequent Development of COPD
Preserved Ratio Impaired Spirometry (PRISM)
Not yet recruitingObservational study
Mitigating Chronic Respiratory Disease Through the Lens of Multimorbidity (MARES3)
Chronic Obstructive Pulmonary Disease (COPD), Asthma
Not yet recruitingObservational study
Respiratory Disease Cohort Studies of Chinese Medicine for COPD(RESEARCH-COPD)
Chronic Obstructive Pulmoriary Disease (COPD), Preserved Ratio Impaired Spirometry (PRISM)

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.

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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Trough forced expiratory volume in the first second (trough FEV1) (time frame: Baseline, Week 6, and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07595796.

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 19 May 2026; AzTrials last refreshed its copy on 2 Nov 2026.