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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

661 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-21

Study Completion Date

2022-03-04

Brief Summary

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

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Detailed Description

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Conditions

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COPD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient in treatment with BDP/FF/G fixed combination

BDP/FF/G fixed combination

Intervention Type 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).

Interventions

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BDP/FF/G fixed combination

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).

Intervention Type DRUG

Other Intervention Names

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Trimbow

Eligibility Criteria

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Inclusion Criteria

1. Written informed consent to participate in the study;
2. Adult patients of either sex aged ≥ 40 years;
3. 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);
4. COPD assessment test (CAT) score ≥ 10 at initiation of BDP/FF/G fixed combination;
5. History of \>1 moderate or severe COPD exacerbation during the previous year.
6. Patients in treatment with BDP/FF/G as per local clinical practice and according to Trimbow® Summary of Product Characteristics (SmPC).

Exclusion Criteria

1. 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;
2. Participation in an interventional clinical trial within 30 days prior to enrolment into the present study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No