Clinical trial NCT03963167: Triple Therapy in Real-life: Impact on Adherence and Health Status (TRITRIAL)
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Keywords: COPD
Adherence
HRQoL determinants
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2019-05-24
Enrollment: 661
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients with symptoms and history of exacerbations despite of maintenance therapy

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


Eligibility criteria: 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.

Primary outcomes:
measure: Change in COPD Assessment Test (CAT) score
timeFrame: 12 months
Secondary outcomes:
measure: Change in COPD Assessment Test (CAT) score
timeFrame: 6 months
measure: Change in 12-item Test of Adherence to Inhalers (TAI-12) score
timeFrame: 6 and 12 months
measure: Change in COPD and Asthma Sleep Impact Scale (CASIS) score
timeFrame: 6 and 12 months
measure: Change in EuroQoL score
timeFrame: 6 and 12 months
measure: Change of an 8-item questionnaire on satisfaction and usability of the device score from baseline (Visit 1)
timeFrame: 6 and 12 months
measure: Forced Expiratory Volume in the first second (FEV1, L)
timeFrame: Baseline, 6 and 12 months
measure: Forced Vital Capacity (FVC, L)
timeFrame: Baseline, 6 and 12 months
measure: Mean forced expiratory flow between 25% and 75% of the FVC (FEF25-75)
timeFrame: Baseline, 6 and 12 months
measure: Ratio FEV1/FVC
timeFrame: Baseline, 6 and 12 months
measure: Use of rescue medication
timeFrame: Baseline, 6 and 12 months
measure: Exacerbations
timeFrame: Baseline, 6 and 12 months
measure: Adverse events
timeFrame: Baseline, 6 and 12 months
measure: Economic resources consumption
timeFrame: Baseline, 6 and 12 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Gemelli
Study officials:
affiliation: Policlinico Gemelli, Roma (Italy)
name: Luca Richeldi, MD
role: PRINCIPAL_INVESTIGATOR
References: