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

Study Identifier:
DFIDM-1802
ClinicalTrials.gov Identifier:
NCT03963167
EudraCT Identifier:
N/A
EU CT ID:
N/A
Study Contact Information:
N/A
See Study Publication Below
Study Complete

Trial Documents

Scientific Result Summary
Available Languages: English
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Protocol
Available Languages: English
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Plain Language Summary
Available Languages: Italian
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Study Details

Medical Condition
  • Chronic Obstructive Pulmonary Disease
Study Drug
  • Drug: BDP/FF/G fixed combination
Date
Aug 2019 - Mar 2022
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • 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).
Exclusion Criteria
  • 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.
Healthy Volunteers
No

Protocol Summary

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

Study Locations

Location
Status
Location
Fondazione Policlinico Gemelli
Rome, Italy
Status
N/A

Study Publications

Richeldi L, Piraino A, Macagno F, Micarelli G, Ingrassia E. The Impact of Fixed Triple Therapy with Beclometasone/Formoterol/Glycopyrronium on Health Status and Adherence in Chronic Obstructive Pulmonary Disease (COPD) in an Italian Context of Real Life: The TRITRIAL Study Protocol. Int J Chron Obstruct Pulmon Dis. 2021 Jan 27;16:159-166. doi: 10.2147/COPD.S286559. eCollection 2021.Richeldi L, Schino P, Bargagli E, Ricci A, Rocca A, Marchesani F, Pennisi A, Camiciottoli G, D'Amato M, Macagno F, Scaffidi Argentina U, Ingrassia E, Piraino A. TRITRIAL: The Impact of Fixed Triple Therapy with Beclometasone/Formoterol/Glycopyrronium on Health Status and Adherence in Chronic Obstructive Pulmonary Disease in an Italian Context of Real Life. Int J Chron Obstruct Pulmon Dis. 2024 Feb 23;19:475-487. doi: 10.2147/COPD.S445858. eCollection 2024.