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

COPD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03963167
• Other study ID #: DFIDM-1802
• Status: Completed
• Start date: August 21, 2019
• Est. completion date: March 4, 2022

Study information

• Verified date: May 2022
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 661
• Est. completion date: March 4, 2022
• Est. primary completion date: March 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COPD

Intervention

Drug:
• BDP/FF/G fixed combination
Fixed combination of Inhaled Corticosteroid (ICS) / Long-acting ß2-agonist (LABA) / long-acting muscarinic antagonist (LAMA) that contains Beclometasone dipropionate (BDP), Formoterol fumarate (FF) and Glycopyrronium (G).

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Gemelli	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Italia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Forced Expiratory Volume in the first second (FEV1, L)		Baseline, 6 and 12 months
Secondary	Forced Vital Capacity (FVC, L)		Baseline, 6 and 12 months
Secondary	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
Secondary	Ratio FEV1/FVC	Derived from these highest values of each parameter	Baseline, 6 and 12 months
Secondary	Use of rescue medication	Use of rescue medication	Baseline, 6 and 12 months
Secondary	Exacerbations	Moderate to severe exacerbations	Baseline, 6 and 12 months
Secondary	Adverse events	Number of adverse events	Baseline, 6 and 12 months
Secondary	Economic resources consumption	Number of hospitalizations, ER access, unscheduled visits	Baseline, 6 and 12 months