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NCT06283966ClinicalTrials.gov

A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease

A Randomized, Double-blind, Parallel Group, Multi-center, Phase III Study to Assess the Efficacy of Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhaler Relative to Glycopyrronium and Formoterol Fumarate MDI on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease (THARROS)

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.
יצירת קשר עם המחקר

בקצרה

This study will evaluate the effect of triple ICS/LAMA/LABA therapy with BGF MDI 320/14.4/9.6 μg on cardiopulmonary outcomes relative to LAMA/LABA therapy with GFF MDI 14.4/9.6 μg in a population with COPD and elevated cardiopulmonary risk.

שלב 3דרושים 5,000 משתתפים921 אתרים37 מדינות

קטגוריות

מערכת הנשימה100%

רשום במרשם אחד

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

מתעניינים במחקר הזה?

התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.

How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered after enrolment began (about 7 days after the recorded start)First posted 2024-02-28; recorded start 2024-02-21
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Uses blinding (masking)A masking level is recorded in the record
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 1019 other studies in this databaseCounted from the lead sponsor named in the record (AstraZeneca)
  • Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
  • The record lists 1 condition.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding20/20

    Quadruple-blind

  • Control arm0/15

    No comparator arm stated in the record

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 921 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 5,000 participants (target), run at 921 sites, across 37 countries.

How this score is built
  • Enrolment36/40

    5,250 participants (target)

  • Site count25/25

    921 sites

  • Country count15/15

    37 countries

  • Planned duration9/10

    Planned over about 46 months

  • Sponsor scale10/10

    AstraZeneca has led 991 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

תקציר

This study will evaluate the effect of triple ICS/LAMA/LABA therapy with BGF MDI 320/14.4/9.6 μg on cardiopulmonary outcomes relative to LAMA/LABA therapy with GFF MDI 14.4/9.6 μg in a population with COPD and elevated cardiopulmonary risk.

This is a Phase III randomized, double-blind, parallel group, multi-center event-driven study comparing BGF MDI 320/14.4/9.6 μg BID with GFF MDI 14.4/9.6 μg BID in participants with COPD who are at risk of a cardiopulmonary event.

מצבים רפואיים

  • COPD (Chronic Obstructive Pulmonary Disease)

זכאות

מיןהכול
גילאים40 Years – 80 Years
מתנדבים בריאיםלא

זכאות כפי שנכתבה במרשם

Inclusion Criteria: 1. Male or female participants must be 40 to 80 years of age inclusive, at the time of signing the ICF. 2. Demonstrate acceptable MDI administration technique at Visit 1 (V1) and Visit 2 (V2) 3. A diagnosis of COPD confirmed by a post-bronchodilator FEV1/FVC ratio \< 70% at V1. 4. Current or former smokers with a history of at least 10 pack-years of cigarette smoking; defined as (number of cigarettes per day/20) x number of years smoked. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to V1. 5. A baseline peripheral blood eosinophil count of ≥ 100 cells/mm3 assessed at Visit 1 by the central laboratory 6. A CAT score of ≥ 10 at Visit 1. 7. Participant must fulfill at least 1 of the 4 CV disease/risk factor criteria below \[(a), (b), (c), or (d)\]: 1. : Established CV Disease 2. : Combination of CV risk factors: * Hypertension * Diabetes Mellitus * Chronic Kidney Disease * Dyslipidemia * Obesity 3. : High risk of CV disease determined using an established CV risk assessment tool. 4. : CT coronary Artery Calcification 8. Willing and, in the opinion of the investigator, able to adjust current COPD therapy, as required by the protocol. 9. Willing to visit at the study site or participate in virtual visits as required per the protocol to complete all study assessments. 10. A female is eligible to enter and participate in the study if the female is of: * Non-childbearing potential: either permanently sterilized or who are post-menopausal. * Childbearing potential: has a negative serum pregnancy test at V1 and must use one highly effective form of birth control. 11. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol. Exclusion Criteria: 1. Active diagnosis of asthma within the past 5 years (previous diagnosis as a child or adolescent are eligible), asthma-COPD overlap, or any other chronic respiratory disease other than COPD such as alpha-1 antitrypsin deficiency, active tuberculosis, lung fibrosis, sarcoidosis, interstitial lung disease, and pulmonary hypertension. 2. End-stage renal disease requiring renal replacement therapy 3. History of heart or lung transplant or actively listed for heart or lung transplant. 4. Implanted left ventricular assist device or implant anticipated in \< 3 months. 5. History of lung cancer and/or treatment for lung cancer within the 5 years prior to Visit 1. 6. Unstable or life-threatening cardiac disease - participants with any of the following at Visit 1 would be excluded: 1. An MI or unstable angina in the last 8 weeks 2. Unstable or life-threatening cardiac arrhythmia requiring intervention in the last 8 weeks. NOTE: Any participant who experiences unstable or life-threatening cardiac disease during the run-in period will be excluded but can be rescreened 8 weeks after the resolution of the event. 7. Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 8 weeks prior to Visit 1 8. Any life-threatening condition, including malignancy, with a life expectancy \< 5 years, other than CV disease or COPD, that might prevent the participant from completing the study. 9. Use of maintenance ICS treatment within the past 12 months. 10. Unable to abstain from protocol-defined prohibited medications 11. Participation in another clinical study with a study intervention administered in the last 30 days or 5 half-lives, whichever is longer prior to Visit 1 (any other investigational product that is not identified in protocol is prohibited for use during the duration of the study). 12. Participants with a known hypersensitivity to LAMA, LABA or ICS or any component of the MDI. 13. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). 14. Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements. 15. Previous randomization in the present study. 16. For females only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

סוג המחקרהתערבותי
שלבשלב 3
הקצאהאקראי
מודל ההתערבותPARALLEL
מטרה ראשיתTREATMENT
הסתרהQUADRUPLE (4)
גיוסדרושים 5,000 משתתפים

נותן חסות ושותפים

  • AstraZeneca נותן חסות

זרועות והתערבויות

  • BGF armEXPERIMENTAL

    BGF MDI 320/14.4/9.6 μg BID

  • GFF armEXPERIMENTAL

    GFF MDI 14.4/9.6 μg BID

התערבויות

  • תרופה BGF MDI 320/14.4/9.6 μg

    Budesonide, glycopyrronium, and formoterol fumarate pressurized inhalation suspension

  • תרופה GFF MDI 14.4/9.6 μg

    Glycopyrronium and formoterol fumarate pressurized inhalation suspension

מדדי תוצאה

  1. מדד תוצאה ראשוני

    Time to first severe cardiac or COPD event

    Evaluate the effect of combination triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on cardiopulmonary outcomes.

    מסגרת זמן Up to 3 years

  2. מדד תוצאה משני

    Time to first severe COPD exacerbation event

    Evaluate the effect of combination triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on severe COPD exacerbations.

    מסגרת זמן Up to 3 years

  3. מדד תוצאה משני

    Time to first severe cardiac event

    Evaluate the effect of combination triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on severe cardiac outcomes.

    מסגרת זמן Up to 3 years

  4. מדד תוצאה משני

    Time to cardiopulmonary death

    Evaluate the effect of combination triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on cardiopulmonary deaths.

    מסגרת זמן Up to 3 years

  5. מדד תוצאה משני

    Moderate/severe COPD exacerbation rate

    Evaluate the effect of combination triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on moderate/severe COPD exacerbations.

    מסגרת זמן Over time, up 3 years

  6. מדד תוצאה משני

    Time to Myocardial Infarction (MI) hospitalization or cardiac death

    Evaluate the effect of combination triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on the time to MI hospitalization (or cardiac death).

    מסגרת זמן Up to 3 years

  7. מדד תוצאה משני

    Time to Heart Failure (HF) acute healthcare visit/hospitalization or cardiac death

    Evaluate the effect of combination triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on the time to HF acute healthcare visit/hospitalization (or cardiac death).

    מסגרת זמן Up to 3 years

  8. מדד תוצאה אחר

    Serious Adverse Events (SAEs) and Adverse Events leading to discontinuation (DAEs), Adverse Events of Special Interest (AESIs) of pneumonia leading to hospitalization or death

    To assess the safety and tolerability of BGF MDI and GFF MDI

    מסגרת זמן Up to 3 years

תאריכים

תאריך התחלה21 בפברואר 2024 (בפועל)
סיום ראשוני3 בדצמבר 2027 (משוער)
סיום3 בדצמבר 2027 (משוער)
פורסם לראשונה28 בפברואר 2024 (בפועל)
עודכן לאחרונה26 באוגוסט 2026
התוצאות פורסמולא צוין ברשומת המרשם
המצב אומת לאחרונהאוגוסט 2026

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

685 אתרים מגייסים

Argentina

מתקןעירמדינה או אזורמצב
Research SiteBuenos Airesמגייס
Research SiteBuenos Airesמגייס
Research SiteBuenos Airesמגייס
Research SiteCABAמגייס
Research SiteCapital Federalמגייס
Research SiteCiudad de Buenos Airesמגייס
Research SiteCiudad de Buenos Airesמגייס
Research SiteFloridaמגייס
Research SiteMar del Plataמגייס
Research SiteMendozaמגייס
Research SiteRanelaghמגייס
Research SiteRosarioמגייס
Research SiteSan Fernandoמגייס
Research SiteSan Juan Bautistaמגייס
Research SiteSan Miguel de Tucumánמגייס
Research SiteSan Miguel de Tucumánמגייס

Australia

מתקןעירמדינה או אזורמצב
Research SiteBirtinyaמגייס
Research SiteCairnsבוטל
Research SiteChermsideהושלם
Research SiteCoffs Harbourמגייס
Research SiteDubboמגייס
Research SiteNedlandsמגייס
Research SitePort Macquarieבוטל
Research SiteSpearwoodהושלם
Research SiteSt Albansמגייס
Research SiteSt Albansהושלם
Research SiteWaitaraמגייס
Research SiteWangarattaבוטל

Austria

מתקןעירמדינה או אזורמצב
Research SiteBad Ischlמגייס
Research SiteBraunau am Innמגייס
Research SiteFeldbachמגייס
Research SiteGrazמגייס
Research SiteViennaבוטל

Brazil

מתקןעירמדינה או אזורמצב
Research SiteBelo Horizonteבוטל
Research SiteBelo Horizonteמגייס
Research SiteBelo Horizonteמגייס
Research SiteBlumenauהושלם
Research SiteBrasíliaמגייס
Research SiteBrasíliaמגייס
Research SiteBrasíliaמגייס
Research SiteBrasíliaבוטל
Research SiteCampina Grande do Sulמגייס
Research SiteCampinasמגייס
Research SiteCaxias do Sulבוטל
Research SiteCuritibaמגייס
Research SiteCuritibaמגייס
Research SiteCuritibaמגייס
Research SiteFortalezaהושלם
Research SiteIjuíמגייס
Research SiteJuiz de Foraהושלם

871 אתרים נוספים מצוינים ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

  1. 26 באוגוסט 2026

    יעד הגיוס השתנה

    Enrollment target revised down from 5250 to 5000

    52505000

מרשם: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT06283966