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Completed

NCT Number: NCT01917331

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dr Beatrix BALINT

Szeged, 6722, Hungary

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Beclometasone/formoterol/glycopyrrolate

Drug

Active drug tested

Other names: BDP/FF/GB or CHF 5993 pMDI 100/6/12.5 µg

Beclometasone/formoterol

Drug

Active comparator

Other names: Foster® or CHF 1535 pMDI 100/6 µg

Primary outcomes

  1. 1_Change From Baseline in Pre-dose Morning Forced Expiratory Volume in the 1st Second (FEV1) -- at Week 26

    Time frame: 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.

  2. 2_Change From Baseline in 2-hour Post-dose FEV1 -- at Week 26

    Time frame: 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.

  3. 3_Transition Dyspnoea Index (TDI) Focal Score -- at Week 26

    Time frame: 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

Secondary outcomes

  1. 4_Change From Baseline in Pre-dose Morning FEV1 -- at All the Other Clinic Visits

    Time frame: 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.

  2. 5_Change From Baseline to the Average in Pre-dose Morning FEV1 -- Over the Treatment Period

    Time frame: 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.

  3. 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

    Time frame: 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.

  4. 7_Change From Baseline in 2-hour Post-dose of FEV1 -- at All the Other Clinic Visits

    Time frame: 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.

  5. 8_Change From Pre-dose to 2-hour Post-dose FEV1 -- at All Study Visits

    Time frame: 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.

  6. 9_Transition Dyspnoea Index (TDI) Focal Score -- at All Study Visits

    Time frame: 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

  7. 10_Number of Participants With Transition Dyspnoea Index (TDI) Response (Focal Score ≥1) -- at Week 26 and Week 52

    Time frame: 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.

  8. 11a_Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) -- at All Study Visits: Total Score

    Time frame: 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).

  9. 11b_Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) -- at All Study Visits: Symptoms Score

    Time frame: 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.

  10. 11c_Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) -- at All Study Visits: Impacts Score

    Time frame: 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.

  11. 11d_Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) -- at All Study Visits: Activity Score

    Time frame: 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.

  12. 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

    Time frame: 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.

  13. 13a_Change From Baseline for Percentage of Days Without Intake of Rescue Medication -- Over Entire Treatment Period (52 Weeks of Treatment)

    Time frame: 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.

  14. 13b_Change From Baseline for the Average Use of Rescue Medication -- Over Entire Treatment Period (52 Weeks of Treatment)

    Time frame: 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).

  15. 14_Rate of Moderate and Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Rate -- Over Entire Treatment Period (52 Weeks of Treatment)

    Time frame: 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

  16. 15_First Occurrence of All Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Chiesi Farmaceutici S.p.A.

Industry

Registry information

Official study title

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

Acronym: TRILOGY

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 6, 2013
Registry last updated
Jul 20, 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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