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Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate Versus Foster® in COPD (TRILOGY)

7. maj 2026 opdateret af: Chiesi Farmaceutici S.p.A.

A Phase 3 Randomised Double Blind Randomised Parallel Multinational Trial Comparing a Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate to Foster® in Patients With Chronic Obstructive Pulmonary Disease

Randomized,double-blind,multicenter,multinational,parallel-group,Phase III study to demonstrate the superiority of the triple fixed combination of beclometasone + formoterol + glycopyrrolate (BDP/FF/GB) administered via pressurised metered dose inhaler (pMDI) over the equivalent dose of Foster® (beclometasone dipropionate (BDP) / formoterol fumarate (FF), in patients diagnosed with chronic obstructive pulmonary disease (COPD) after 52 weeks of treatment.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This 52-week randomised 2 parallel groups study evaluated the superiority of fixed triple therapy with Inhaled Corticosteroid (ICS) / Long-Acting β2-Agonist (LABA) / Long-Acting Muscarinic Antagonist (LAMA) compared with ICS/LABA in patients with severe to very severe diagnosed of COPD.

Patients' eligibility was checked during the screening visit including the review of medical history, spirometry assessments, routine labs, physical examination, 12-lead electrocardiogram (ECG), vital signs measurement, prior to entering a 2-week open-label run-in period with BDP/FF to establish a baseline.

After the run-in period, eligible patients were randomised, to either fixed triple therapy BDP/FF/GB or BDP/FF treatment group. During the 52-week treatment period, patients who completed the study did have 5 subsequent visits post randomisation scheduled respectively after 4, 12, 26, 40, and 52 weeks of treatment. During these visits, pre-dose and post-dose spirometry, 12-lead ECG, vital signs, and dyspnoea assessments were performed. Rescue medication use, compliance with the treatment, and EXACT-PRO questionnaire [EXAcerbations of Chronic Obstructive Pulmonary Disease Tool (EXACT): a patient-reported outcome (PRO)] were recorded daily (via an electronic diary) during the run-in and randomised treatment periods.

For pharmacovigilance purposes, adverse events (AE) were recorded from the time of patient informed consent signature until subject's study participation ended (Week 52 or early discontinuation).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1368

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Ungarn
      • Szeged, Ungarn, 6722
        • Dr Beatrix BALINT

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Male or female adults aged ≥ 40 years with a diagnosis of COPD
  • Current smokers or ex-smokers
  • A post-bronchodilator Forced Expiratory Volume in the 1st Second (FEV1) < 50% of the predicted normal value and a post- bronchodilator FEV1/ Forced Vital Capacity (FVC) < 0.7
  • At least one exacerbation in the 12 months preceding the screening visit

Exclusion Criteria:

  • Pregnant or lactating women
  • Diagnosis of asthma or history of allergic rhinitis or atopy
  • Patients treated with non-cardioselective β-blockers in the month preceding the screening visit
  • Patients treated for exacerbations in the 4 weeks prior to screening visit
  • Patients treated with long-acting antihistamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study or if taken as PRN
  • Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia
  • Known respiratory disorders other than COPD
  • Patients who have clinically significant cardiovascular condition

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Beclometasone/Formoterol/Glycopyrrolate
CHF 5993 pMDI 100/6/12.5 µg 2 inhalations bid
Medicin: Beclometasone/Formoterol/Glycopyrrolate
Active drug tested
Andre navne:
  • BDP/FF/GB or CHF 5993 pMDI 100/6/12.5 µg
Aktiv komparator: Beclometasone/Formoterol
Foster® 100/6 µg 2 inhalations bid
Medicin: Beclometasone/Formoterol
Active comparator
Andre navne:
  • Foster® or CHF 1535 pMDI 100/6 µg

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
1_Change From Baseline in Pre-dose Morning Forced Expiratory Volume in the 1st Second (FEV1) -- at Week 26
Tidsramme: Baseline (Week 0), Week 26.

Changes from baseline in pre-dose morning FEV1 to visit at Week 26.

FEV1=Forced expiratory volume in the 1st second. It is the volume of air that can be forced out in one second after taking a deep breath.
Baseline (Week 0), Week 26.
2_Change From Baseline in 2-hour Post-dose FEV1 -- at Week 26
Tidsramme: Baseline (Week 0) to 2-hour post-dose at Week 26.

Change from baseline in 2-hour post-dose FEV1, at Week 26.

FEV1=Forced expiratory volume in the 1st second. It is the volume of air that can be forced out in one second after taking a deep breath.
Baseline (Week 0) to 2-hour post-dose at Week 26.
3_Transition Dyspnoea Index (TDI) Focal Score -- at Week 26
Tidsramme: Baseline (Week 0), Week 26.

Transition Dyspnoea Index (TDI) focal score is a symptom-based variable tool, used to assess breathlessness and the impact of intervention. BDI/TDI is a clinical rating method based on a validated tool that measures the impact of dyspnoea based on 3 domains: functional impairment, magnitude of task, and magnitude of effort. BDI focal score is the baseline value from which TDI focal score is assessed.

BDI scores range from 0 (very severe impairment) to 4 (no impairment) for each domain with the baseline focal score consisting of the sum of each domain (i.e. from 0 to 12). Change from baseline in dyspnoea severity was measured using the TDI. TDI score ranges from -3 (major deterioration) to +3 (major improvement) for each domain, with the TDI focal score consisting of the sum of each domain (i.e. from -9 to +9). A higher total score indicates improvement, while a lower or negative score indicates worsening symptoms.

BDI=Baseline Dyspnoea Index TDI=Transition Dyspnoea Index
Baseline (Week 0), Week 26.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
4_Change From Baseline in Pre-dose Morning FEV1 -- at All the Other Clinic Visits
Tidsramme: Baseline (Week 0), Week 4. 12, 40, 52.

Change from baseline in pre-dose morning FEV1, at all the other clinic visits.

Please note: results at visit Week 26, are presented as the primary outcome measure #1 for this study.

FEV1=Forced expiratory volume in the 1st second. It is the volume of air that can be forced out in one second after taking a deep breath.
Baseline (Week 0), Week 4. 12, 40, 52.
5_Change From Baseline to the Average in Pre-dose Morning FEV1 -- Over the Treatment Period
Tidsramme: Baseline (Week 0), Week 4, 12, 26, 40, 52.

Changes from baseline for the average in pre-dose morning FEV1 over the treatment period.

FEV1=Forced expiratory volume in the 1st second. It is the volume of air that can be forced out in one second after taking a deep breath.
Baseline (Week 0), Week 4, 12, 26, 40, 52.
6_Number of Participants Defined as Responders Wrt. to FEV1 -- Change From Baseline in Pre-dose Morning FEV1 ≥100 mL -- at Week 26 and Week 52
Tidsramme: Baseline (Week 0), Week 26, Week 52.

Number of participants defined as responders wrt. to FEV1 -- at Week 26 and Week 52.

FEV1 response was defined as a change from baseline in pre-dose morning FEV1 of ≥100 mL. If the change from baseline was <100 mL, the patient was classified as a non-responder in terms of FEV1. Subjects with missing pre-dose morning FEV1 value at the pre-specified tested time points were also classified as non-responders.

FEV1=Forced expiratory volume in the 1st second. It is the volume of air that can be forced out in one second after taking a deep breath.
Baseline (Week 0), Week 26, Week 52.
7_Change From Baseline in 2-hour Post-dose of FEV1 -- at All the Other Clinic Visits
Tidsramme: Baseline (Week 0), Week 4, 12, 40, 52.

Change from baseline in 2-hour post-dose of FEV1, at all the other clinic visits.

Please note: a) results at visit Week 26, are presented as the primary outcome measure #2 for this study; b) for Week 0, the measurement shown in the results table below was made 2 h after the baseline measurement i.e. pre-treatment at study baseline.

FEV1=Forced expiratory volume in the 1st second. It is the volume of air that can be forced out in one second after taking a deep breath.
Baseline (Week 0), Week 4, 12, 40, 52.
8_Change From Pre-dose to 2-hour Post-dose FEV1 -- at All Study Visits
Tidsramme: Week 4, 12, 26, 40, 52.

Change from pre-dose to 2-hour post-dose value of FEV1, at study visits on Week 4, 12, 26, 40, and 52.

FEV1=Forced expiratory volume in the 1st second. It is the volume of air that can be forced out in one second after taking a deep breath.
Week 4, 12, 26, 40, 52.
9_Transition Dyspnoea Index (TDI) Focal Score -- at All Study Visits
Tidsramme: Baseline (Week 0), Week 4, 12, 40, 52.

TDI focal score is a symptom-based tool, used to assess breathlessness and the impact of intervention.

BDI/TDI is a clinical rating method based on a validated tool that measures the impact of dyspnoea on 3 domains: functional impairment, magnitude of task, and magnitude of effort.

TDI tool and its scoring system are defined in the outcome measure #3 of this PRS study entry.

Please note: Results at Week 26, are presented as the primary outcome measure #3 for this PRS study entry.

BDI=Baseline Dyspnoea Index TDI=Transition Dyspnoea Index
Baseline (Week 0), Week 4, 12, 40, 52.
10_Number of Participants With Transition Dyspnoea Index (TDI) Response (Focal Score ≥1) -- at Week 26 and Week 52
Tidsramme: Week 26, Week 52.

Number of participants with transition dyspnoea index (TDI) response (focal score ≥1) -- at Week 26 and Week 52.

TDI tool and its scoring system are defined in the outcome measure #3 of this PRS study entry.

TDI response was defined as a TDI focal score of ≥1. If the TDI focal score was <1, the patient was classified as a non-responder in terms of TDI. Patients with missing TDI focal score at the pre-specified tested time points were also classified as non-responders.
Week 26, Week 52.
11a_Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) -- at All Study Visits: Total Score
Tidsramme: Baseline (Week 0), Week 4, 12, 26, 40, 52.

Change from baseline in Saint George's respiratory questionnaire (SGRQ) Total score.

SGRQ is a 76-item questionnaire developed to measure health in chronic airflow limitation. SGRQ consists of scores from three component that are used to calculate the total score: Symptoms, Activity, and Impacts on daily life. SGRQ questionnaire was completed by the patient at all study visits (Week 0 baseline, and Week 4, 12, 26, 40, 52).

The Total score range is from 0 to 100 (0=Best, 100=Worst); lower scores correspond to better health.

SGRQ questionnaire was completed by the patient at all study visits (Week 0 baseline, 4, 12, 26, 40, 52).
Baseline (Week 0), Week 4, 12, 26, 40, 52.
11b_Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) -- at All Study Visits: Symptoms Score
Tidsramme: Baseline (Week 0), Week 4, 12, 26, 40, 52.

Change from baseline in Saint George's respiratory questionnaire (SGRQ) -- Symptoms Score.

SGRQ is a questionnaire developed to measure health in chronic airflow limitation.

SGRQ questionnaire was completed by the patient at all study visits (Week 0 baseline, 4, 12, 26, 40, 52).

Result show the Saint George's Respiratory Questionnaire (SGRQ) as change from baseline for the domain Symptoms.

The Symptoms score is calculated on a scale of 0 to 100. A score of 0 indicates no impairment (best health); a score of 100 indicates the worst possible health status.
Baseline (Week 0), Week 4, 12, 26, 40, 52.
11c_Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) -- at All Study Visits: Impacts Score
Tidsramme: Baseline (Week 0), Week 4, 12, 26, 40, 52.

Saint George's respiratory questionnaire (SGRQ) -- Impacts Score.

SGRQ is a questionnaire developed to measure health in chronic airflow limitation.

SGRQ questionnaire was completed by the patient at all study visits (Week 0 baseline, 4, 12, 26, 40, 52).

Result show the Saint George's Respiratory Questionnaire (SGRQ) as change from baseline for the domain Impacts.

The Impact score is calculated on a scale of 0 to 100. A score of 0 indicates no impairment (best health); a score of 100 indicates the worst possible health status.
Baseline (Week 0), Week 4, 12, 26, 40, 52.
11d_Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) -- at All Study Visits: Activity Score
Tidsramme: Baseline (Week 0), Week 4, 12, 26, 40, 52.

Saint George's respiratory questionnaire (SGRQ) -- Activity score.

SGRQ is a questionnaire developed to measure health in chronic airflow limitation.

SGRQ questionnaire was completed by the patient at all study visits (Week 0 baseline, 4, 12, 26, 40, 52).

Result show the Saint George's Respiratory Questionnaire (SGRQ) as change from baseline for the domain Activity.

The Activity score is calculated on a scale of 0 to 100. A score of 0 indicates no impairment (best health); a score of 100 indicates the worst possible health status.
Baseline (Week 0), Week 4, 12, 26, 40, 52.
12_Number of Participants With Saint George's Respiratory Questionnaire (SGRQ) Response (Change From Baseline in Total Score ≤-4) -- at Week 26 and Week 52
Tidsramme: Baseline (Week 0), Week 26, Week 52.

Number of participants with Saint George's Respiratory Questionnaire (SGRQ) response, defined as a change from baseline in SGRQ total score ≤ -4, at Week 26 and Week 52.

If the change from baseline was > -4, the patient was assessed as a non-responder in terms of SGRQ.

Patients with missing change from baseline at the pre-specified tested time points were also classified as non-responders.

Results shown represent the number of responder participants in terms of SGRQ, for the comparison of CHF 5993 pMDI versus CHF 1535 pMDI.
Baseline (Week 0), Week 26, Week 52.
13a_Change From Baseline for Percentage of Days Without Intake of Rescue Medication -- Over Entire Treatment Period (52 Weeks of Treatment)
Tidsramme: Baseline (Week 0) to Week 4, 12, 26, 40, 52.

Days WITHOUT intake of rescue medication.

Change from baseline to each inter-visit period and for the entire treatment period (Week 1-52) in the percentage of days without intake of rescue medication.
Baseline (Week 0) to Week 4, 12, 26, 40, 52.
13b_Change From Baseline for the Average Use of Rescue Medication -- Over Entire Treatment Period (52 Weeks of Treatment)
Tidsramme: Baseline (Week 0) to Week 4, 12, 26, 40, 52.

Average use of rescue medication, over the entire treatment period (52 Weeks of treatment).

Change from baseline to each inter-visit period and for the entire treatment period (Week 1-52) in the average use of rescue medication (number of puffs/day).
Baseline (Week 0) to Week 4, 12, 26, 40, 52.
14_Rate of Moderate and Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Rate -- Over Entire Treatment Period (52 Weeks of Treatment)
Tidsramme: Baseline (Week 0) to Week 52 (entire treatment period).

Rate of moderate AND severe COPD exacerbations over the entire treatment period of treatment (52 weeks).

COPD=Chronic obstructive pulmonary disease
Baseline (Week 0) to Week 52 (entire treatment period).
15_First Occurrence of All Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Tidsramme: Baseline (Week 0), Week 52.

First occurrence of at least 1 moderate OR severe COPD exacerbation.

First occurrence was analysed by Cox regression as time to first exacerbation and reported as hazard ratio.

COPD=Chronic obstructive pulmonary disease
Baseline (Week 0), Week 52.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Chiesi Farmaceutici S.p.A.

Efterforskere

  • Ledende efterforsker: Dave SINGH, MD, University Hospital of South Manchester, MANCHESTER M23 9 QZ, UK

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

21. marts 2014

Primær færdiggørelse (Faktiske)

14. januar 2016

Studieafslutning (Faktiske)

14. januar 2016

Datoer for studieregistrering

Først indsendt

5. august 2013

Først indsendt, der opfyldte QC-kriterier

5. august 2013

Først opslået (Anslået)

6. august 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CCD-1207-PR-0091

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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