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Completed

NCT Number: NCT03963167

Triple Therapy in Real-life: Impact on Adherence and Health Status (TRITRIAL)

The mean objectives are to evaluate the impact of BDP/FF/G fixed combination on health-status and adherence

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Key information

Conditions

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

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Gemelli

Rome, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Written informed consent to participate in the study;
  • Adult patients of either sex aged ≥ 40 years;
  • Patients with diagnosis of moderate to very severe COPD according to Gold Initiative for Chronic Obstructive Lung Disease (GOLD) updated 2019 (GOLD Stage 2-4);
  • COPD assessment test (CAT) score ≥ 10 at initiation of BDP/FF/G fixed combination;
  • History of >1 moderate or severe COPD exacerbation during the previous year.
  • Patients in treatment with BDP/FF/G as per local clinical practice and according to Trimbow® Summary of Product Characteristics (SmPC).

Exclusion criteria

  • According on Investigator's judgement, patients unable to comply with the requirements of the study (e.g. inability to attend all the planned study visits according to the time limits included) or patients with poorly controlled concomitant severe diseases or conditions that could interfere with the study participation;
  • Participation in an interventional clinical trial within 30 days prior to enrolment into the present study.

Treatment and study plan

BDP/FF/G fixed combination

Drug

Fixed combination of Inhaled Corticosteroid (ICS) / Long-acting β2-agonist (LABA) / long-acting muscarinic antagonist (LAMA) that contains Beclometasone dipropionate (BDP), Formoterol fumarate (FF) and Glycopyrronium (G).

Other names: Trimbow

Primary outcomes

  1. Change in COPD Assessment Test (CAT) score

    Time frame: 12 months

    CAT consists of 8 items scored on a scale of 1 to 5, with a total score range of 0-40. A higher score denotes a more severe impact of COPD on the patient's life.

Secondary outcomes

  1. Change in COPD Assessment Test (CAT) score

    Time frame: 6 months

    CAT consists of 8 items scored on a scale of 1 to 5, with a total score range of 0-40. A higher score denotes a more severe impact of COPD on the patient's life.

  2. Change in 12-item Test of Adherence to Inhalers (TAI-12) score

    Time frame: 6 and 12 months

    TAI comprises a patient domain (including 10 items) and a healthcare professional domain (including 2 items). Each item ranges from 1 (lowest adherence) to 5 (highest adherence) points. The patient domain score ranges from 10 to 50. Adherence is rated as good (score =50), intermediate (score = 46-49), or poor (score ≤45). The questions for healthcare professionals are scored with 1 or 2 points (poor or good knowledge of the regimen and/or inhalation technique).

  3. Change in COPD and Asthma Sleep Impact Scale (CASIS) score

    Time frame: 6 and 12 months

    It is a self-administered 7-item scale scored on a five-point scale ranging from 0 if the item never applies, to 4 if the item applies very often. A total raw score is produced from the sum of the seven individual scores which is then linearly transformed to a 0-100 total scale score. Higher scores representing greater sleep deterioration in the previous week.

  4. Change in EuroQoL score

    Time frame: 6 and 12 months

    Il consists of 2 pages, a descriptive system and a visual Analogue scale. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each dimension having 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state.The VAS records the respondent's self-rated health on a 10 cm vertical VAS with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.

  5. Change of an 8-item questionnaire on satisfaction and usability of the device score from baseline (Visit 1)

    Time frame: 6 and 12 months

    it contains 8 questions, each scored on a 0-5 Likert scale, which range from 0 (fully disagree) to 5 (fully agree), for a total maximum score of 40. Higher scores indicate a higher ease of use and satisfaction with the inhaler

  6. Forced Expiratory Volume in the first second (FEV1, L)

    Time frame: Baseline, 6 and 12 months

  7. Forced Vital Capacity (FVC, L)

    Time frame: Baseline, 6 and 12 months

  8. Mean forced expiratory flow between 25% and 75% of the FVC (FEF25-75)

    Time frame: Baseline, 6 and 12 months

    Taken from the test with the highest values of FEV1 and FVC

  9. Ratio FEV1/FVC

    Time frame: Baseline, 6 and 12 months

    Derived from these highest values of each parameter

  10. Use of rescue medication

    Time frame: Baseline, 6 and 12 months

    Use of rescue medication

  11. Exacerbations

    Time frame: Baseline, 6 and 12 months

    Moderate to severe exacerbations

  12. Adverse events

    Time frame: Baseline, 6 and 12 months

    Number of adverse events

  13. Economic resources consumption

    Time frame: Baseline, 6 and 12 months

    Number of hospitalizations, ER access, unscheduled visits

Sponsors and collaborators

Lead sponsor

Chiesi Italia

Industry

Registry information

Official study title

The Impact on the Health Status and Adherence in a Real-life Setting of Italian Patients With Chronic Obstructive Pulmonary Disease in Treatment With Trimbow® pMDI b.i.d.: a 12-month Prospective Observational Study

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 24, 2019
Registry last updated
Feb 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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