CompletedNot Applicable

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

Italy661 participantsStarted 2019-08-21

Plain-language summary

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

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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).

✕. 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.

Change in COPD Assessment Test (CAT) score

Timeframe: 12 months

NCT IDNCT03963167

SponsorChiesi Italia

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-03-04