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

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

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

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Drug: BDP/FF/G fixed combination

• Study Type: Observational
• Enrollment (Actual): 661

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy
    • Fondazione Policlinico Gemelli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

COPD patients with symptoms and history of exacerbations despite of maintenance therapy

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient in treatment with BDP/FF/G fixed combination	Drug: 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).; Other Names: Trimbow

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in COPD Assessment Test (CAT) score	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in COPD Assessment Test (CAT) score	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.	6 months
Change in 12-item Test of Adherence to Inhalers (TAI-12) score	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).	6 and 12 months
Change in COPD and Asthma Sleep Impact Scale (CASIS) score	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.	6 and 12 months
Change in EuroQoL score	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'.	6 and 12 months
Change of an 8-item questionnaire on satisfaction and usability of the device score from baseline (Visit 1)	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 and 12 months
Forced Expiratory Volume in the first second (FEV1, L)		Baseline, 6 and 12 months
Forced Vital Capacity (FVC, L)		Baseline, 6 and 12 months
Mean forced expiratory flow between 25% and 75% of the FVC (FEF25-75)	Taken from the test with the highest values of FEV1 and FVC	Baseline, 6 and 12 months
Ratio FEV1/FVC	Derived from these highest values of each parameter	Baseline, 6 and 12 months
Use of rescue medication	Use of rescue medication	Baseline, 6 and 12 months
Exacerbations	Moderate to severe exacerbations	Baseline, 6 and 12 months
Adverse events	Number of adverse events	Baseline, 6 and 12 months
Economic resources consumption	Number of hospitalizations, ER access, unscheduled visits	Baseline, 6 and 12 months

Collaborators and Investigators

• Sponsor: Chiesi Italia
• Investigators: Principal Investigator: Luca Richeldi, MD, Policlinico Gemelli, Roma (Italy)

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2019
• Primary Completion (Actual): March 4, 2022
• Study Completion (Actual): March 4, 2022

Study Registration Dates

• First Submitted: May 14, 2019
• First Submitted That Met QC Criteria: May 23, 2019
• First Posted (Actual): May 24, 2019

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Adherence; COPD; HRQoL determinants
• Other Study ID Numbers: DFIDM-1802

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No