NCT03963167

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
661

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 24, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

August 21, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2022

Completed
Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

2.5 years

First QC Date

May 14, 2019

Last Update Submit

February 19, 2026

Conditions

COPD

Keywords

COPDAdherenceHRQoL determinants

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • Change in COPD Assessment Test (CAT) score

    6 months

  • Change in 12-item Test of Adherence to Inhalers (TAI-12) score

    6 and 12 months

  • Change in COPD and Asthma Sleep Impact Scale (CASIS) score

    6 and 12 months

  • Change in EuroQoL score

    6 and 12 months

  • Change of an 8-item questionnaire on satisfaction and usability of the device score from baseline (Visit 1)

    6 and 12 months

  • +8 more secondary outcomes

Study Arms (1)

Patient in treatment with BDP/FF/G fixed combination

Drug: BDP/FF/G fixed combination

Interventions

BDP/FF/G fixed combinationDRUG

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).

Also known as: Trimbow
Patient in treatment with BDP/FF/G fixed combination

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Gemelli

Rome, Italy

Location

Related Publications (2)

  • 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.

    PMID: 33536751BACKGROUND

  • 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.

    PMID: 38435125RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Luca Richeldi, MD

    Policlinico Gemelli, Roma (Italy)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2019

First Posted

May 24, 2019

Study Start

August 21, 2019

Primary Completion

March 4, 2022

Study Completion

March 4, 2022

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)