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)

En recrutementAccepte des participants actuellement, selon la fiche du registre.

Contacter cette étude

En bref

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.

Phase 35 000 participants recherchés921 sites37 pays

Catégories

Respiratoire100%

Enregistré dans 1 registre

ClinicalTrials.govNCT06283966Ouvrir cette fiche sur ClinicalTrials.govSynchronisé il y a 4 semaines

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Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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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.

Not stated: Registered after enrolment began (about 7 days after the recorded start)First posted 2024-02-28; recorded start 2024-02-21
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: 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.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 1019 other studies in this databaseCounted from the lead sponsor named in the record (AstraZeneca)
Present: 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.

Résumé

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.

Affections

COPD (Chronic Obstructive Pulmonary Disease)

Éligibilité

Éligibilité
Sexe	Tous
Âges	40 Years – 80 Years
Volontaires sains	Non

Éligibilité telle qu'elle figure dans le registre

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

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Conception de l'étude
Type d'étude	Interventionnelle
Phase	Phase 3
Répartition	Randomisée
Modèle d'intervention	PARALLEL
Objectif principal	TREATMENT
Insu	QUADRUPLE (4)
Recrutement	5 000 participants recherchés

Promoteur et collaborateurs

AstraZeneca Promoteur

Groupes et interventions

BGF armEXPERIMENTAL
BGF MDI 320/14.4/9.6 μg BID
GFF armEXPERIMENTAL
GFF MDI 14.4/9.6 μg BID

Interventions

Médicament BGF MDI 320/14.4/9.6 μg
Budesonide, glycopyrronium, and formoterol fumarate pressurized inhalation suspension
Médicament GFF MDI 14.4/9.6 μg
Glycopyrronium and formoterol fumarate pressurized inhalation suspension

Critères de jugement

Critère de jugement principal
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.
Délai Up to 3 years
Critère de jugement secondaire
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.
Délai Up to 3 years
Critère de jugement secondaire
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.
Délai Up to 3 years
Critère de jugement secondaire
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.
Délai Up to 3 years
Critère de jugement secondaire
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.
Délai Over time, up 3 years
Critère de jugement secondaire
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).
Délai Up to 3 years
Critère de jugement secondaire
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).
Délai Up to 3 years
Autre critère de jugement
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
Délai Up to 3 years

Dates

Dates
Date de début	21 février 2024 (réelle)
Achèvement principal	3 décembre 2027 (estimée)
Achèvement	3 décembre 2027 (estimée)
Première publication	28 février 2024 (réelle)
Dernière mise à jour	26 août 2026
Résultats publiés	Non précisé dans la fiche du registre
Statut vérifié pour la dernière fois	août 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

685 sites sont en recrutement

Argentina

Argentina
Établissement	Ville	Statut
Research Site	Buenos Aires	En recrutement
Research Site	Buenos Aires	En recrutement
Research Site	Buenos Aires	En recrutement
Research Site	CABA	En recrutement
Research Site	Capital Federal	En recrutement
Research Site	Ciudad de Buenos Aires	En recrutement
Research Site	Ciudad de Buenos Aires	En recrutement
Research Site	Florida	En recrutement
Research Site	Mar del Plata	En recrutement
Research Site	Mendoza	En recrutement
Research Site	Ranelagh	En recrutement
Research Site	Rosario	En recrutement
Research Site	San Fernando	En recrutement
Research Site	San Juan Bautista	En recrutement
Research Site	San Miguel de Tucumán	En recrutement
Research Site	San Miguel de Tucumán	En recrutement

Australia

Australia
Établissement	Ville	Statut
Research Site	Birtinya	En recrutement
Research Site	Cairns	Retiré
Research Site	Chermside	Terminé
Research Site	Coffs Harbour	En recrutement
Research Site	Dubbo	En recrutement
Research Site	Nedlands	En recrutement
Research Site	Port Macquarie	Retiré
Research Site	Spearwood	Terminé
Research Site	St Albans	En recrutement
Research Site	St Albans	Terminé
Research Site	Waitara	En recrutement
Research Site	Wangaratta	Retiré

Austria

Austria
Établissement	Ville	Statut
Research Site	Bad Ischl	En recrutement
Research Site	Braunau am Inn	En recrutement
Research Site	Feldbach	En recrutement
Research Site	Graz	En recrutement
Research Site	Vienna	Retiré

Brazil

Brazil
Établissement	Ville	Statut
Research Site	Belo Horizonte	Retiré
Research Site	Belo Horizonte	En recrutement
Research Site	Belo Horizonte	En recrutement
Research Site	Blumenau	Terminé
Research Site	Brasília	En recrutement
Research Site	Brasília	En recrutement
Research Site	Brasília	En recrutement
Research Site	Brasília	Retiré
Research Site	Campina Grande do Sul	En recrutement
Research Site	Campinas	En recrutement
Research Site	Caxias do Sul	Retiré
Research Site	Curitiba	En recrutement
Research Site	Curitiba	En recrutement
Research Site	Curitiba	En recrutement
Research Site	Fortaleza	Terminé
Research Site	Ijuí	En recrutement
Research Site	Juiz de Fora	Terminé

871 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

26 août 2026
Objectif de recrutement modifié
Enrollment target revised down from 5250 to 5000
52505000

Registre: ClinicalTrials.gov · NCT########

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