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NCT Number: NCT07595796

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

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.

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Key information

Conditions

Preserved Ratio Impaired Spirometry (PRISM)

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Budesonide/glycopyrronium bromide/formoterol inhalation aerosol

Drug

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. 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

    • 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.

    • 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.

Sponsors and collaborators

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Other

Registry information

Official study title

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

Acronym: BGF-PRISm

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 19, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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