An Exploratory Study on Triple Inhaler Therapy in Patients With Early Lung Function Impairment (BGF-PRISm)
2026年5月13日 更新者：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.
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
23
段階
- 適用できない
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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).
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Budesonide/Glycopyrronium Bromide/Formoterol
budesonide/glycopyrronium bromide/formoterol inhalation aerosol
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Trough forced expiratory volume in the first second (trough FEV1)
時間枠：Baseline, Week 6, and Week 12
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Pulmonary function tests will be conducted using standardized spirometry (in accordance with ATS/ERS guidelines) at 12 hours post-dose (trough state).
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Baseline, Week 6, and Week 12
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Saint George's Respiratory Questionnaire (SGRQ) Score
時間枠：Baseline, Week 6, and Week 12
|
The standardized SGRQ (Chinese version) will be self-administered by the subjects.
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Baseline, Week 6, and Week 12
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COPD Assessment Test (CAT) Score
時間枠：Baseline, Week 6, and Week 12
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The standardized CAT questionnaire (Chinese version) will be self-administered by the subjects.
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Baseline, Week 6, and Week 12
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Adverse events (AEs) and serious adverse events (SAEs)
時間枠：Baseline, Week 6, and Week 12
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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.
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Baseline, Week 6, and Week 12
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The association between biomarkers (such as peripheral blood eosinophil count and serum IgE level) and treatment efficacy
時間枠：Baseline, Week 6, and Week 12
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Baseline, Week 6, and Week 12
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月1日
一次修了 (推定)
2028年2月29日
研究の完了 (推定)
2028年2月29日
試験登録日
最初に提出
2026年5月13日
QC基準を満たした最初の提出物
2026年5月13日
最初の投稿 (実際)
2026年5月19日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月19日
QC基準を満たした最後の更新が送信されました
2026年5月13日
最終確認日
2026年5月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。