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Active, Not Recruiting

NCT Number: NCT06100042

Observational Study on Therapy Pathways of Asthamics Treated With ICS/LABA/LAMA Therapy in a Real-world Setting

TriMaximize is a non-interventional study aimed to collect prospective data from asthmatic patients under routine care, for whom their treating physician has decided to prescribe BDP/FF/G (beclomethasone/formoterol/glycopyrronium).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

U.O. Clinica Psichiatrica e SPDC. Ospedale Policlinico S. Martino - IRCCS, Genova

Genoa, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients ≥ 18 years of age;
  • Patients with confirmed leading diagnosis of asthma with or without concomitant COPD;
  • Physician decision to start fixed triple therapy with ICS/LABA/LAMA (BDP/FF/G) MS or HS according to its current authorised indication and current reimbursement conditions within the Italian National Health System. The treatment decision must be made independently from participation in this study and may have started within the previous 4 weeks (maximum);
  • Patients willing and able to sign an informed consent for use of their pseudonymised clinical data within the present non-interventional study.

Exclusion criteria

  • Participation in an interventional clinical trial within 30 days prior to enrolment into the present non-interventional study or planned enrolment in an interventional clinical trial during the observational period.

Treatment and study plan

BDP/FF/G

Drug

BDP/FF/G is an extrafine single inhaler triple therapy available in two dosage strengths:

  • Medium strength (MS) containing 100 µg of beclomethasone dipropionate, 6 µg of formoterol fumarate dihydrate and 10 µg of glycopyrronium (as 12.5 µg glycopyrronium bromide);
  • High strength (HS) containing 200 µg of beclomethasone dipropionate, 6 µg of formoterol fumarate dihydrate and 10 µg of glycopyrronium (as 12.5 µg glycopyrronium bromide).

Other names: Trimbow

Primary outcomes

  1. Patient demographics

    Time frame: 12 months

Secondary outcomes

  1. Assessment of asthma control using Asthma Control Test (ACT)

    Time frame: 12 months

    Change from baseline in ACT scores. The ACT is a self-report questionnaire with scores ranging from 5-25 (higher is better). Scores of 20-25 are classified as well-controlled; 16-19 as not well-controlled; and 5-15 as very poorly controlled asthma. The minimum clinically important difference is considered to be 3 point.

  2. Assessment of quality of life using Mini Asthma Quality of Life Questionnaire (Mini AQLQ)

    Time frame: 12 months

    Change from baseline in MiniAQLQ scores. The MiniAQLQ is a disease specific questionnaire that consists of 15 asthma-related questions.

    Participants respond to each question on a 7-point scale (1=severe impairment, 7=no impairment), where higher scores indicated better quality of life. A change in the score greater than 0.5 can be considered clinically important.

  3. Assessment of adherence to treatment using 12-item Test of Adherence to Inhalers (TAI-12)

    Time frame: 12 months

    Change from baseline in TAI-12 score. The 12-item TAI comprises a patient domain (10 items) and a healthcare professional domain (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).

  4. Incidence of asthma exacerbations

    Time frame: 12 months

    Number of exacerbations

  5. Asthma exacerbations

    Time frame: 12 months

    Occurrence of asthma exacerbations

  6. Adverse events

    Time frame: 12 months

    Number of AEs

  7. Adverse drug reactions to BDP/FF/G

    Time frame: 12 months

    Number of ADRs

Sponsors and collaborators

Lead sponsor

Chiesi Italia

Industry

Collaborators

  • Gesellschaft für Therapieforschung mbH

Registry information

Official study title

Multicentre, Prospective, Non-interventional Study Monitoring Therapy Pathways of Asthma Patients Treated With an Extrafine ICS/LABA/LAMA Single-inhaler Triple Therapy in a Real-world Setting and Characterizing the Effects on Health-related Outcomes

Acronym: TRIMAXIMIZE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 25, 2023
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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