An Exploratory Study on Triple Inhaler Therapy in Patients With Early Lung Function Impairment (BGF-PRISm)

May 13, 2026 updated by: zhuansyx, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Budesonide/Glycopyrronium Bromide/Formoterol
budesonide/glycopyrronium bromide/formoterol inhalation aerosol
Drug: Budesonide/glycopyrronium bromide/formoterol inhalation aerosol
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Baseline, Week 6, and Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Saint George's Respiratory Questionnaire (SGRQ) Score
Time Frame: Baseline, Week 6, and Week 12
The standardized SGRQ (Chinese version) will be self-administered by the subjects.
Baseline, Week 6, and Week 12
COPD Assessment Test (CAT) Score
Time Frame: Baseline, Week 6, and Week 12
The standardized CAT questionnaire (Chinese version) will be self-administered by the subjects.
Baseline, Week 6, and Week 12
Adverse events (AEs) and serious adverse events (SAEs)
Time Frame: Baseline, Week 6, and Week 12
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.
Baseline, Week 6, and Week 12

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The association between biomarkers (such as peripheral blood eosinophil count and serum IgE level) and treatment efficacy
Time Frame: Baseline, Week 6, and Week 12

  1. Stratify by baseline peripheral blood eosinophil (EOS) count:

    (i) EOS <100/μL

    (ii) EOS ≥100 to <300/μL

    (iii) EOS ≥300/μL

    Assess the improvement in trough FEV1 according to EOS count level.

  2. Stratify by serum IgE level:

    (i) IgE > upper limit of normal (ULN)

    (ii) IgE normal

    Assess the improvement in trough FEV1 according to IgE level.
Baseline, Week 6, and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 29, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 29, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 19, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SYSKY-2026-195-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings