Fixed Triple Inhaled Combination in Asthmatic Patients in a Real-life Setting

NCT06786767 | Completed

• 3 other identifiers: BG.MED.TRIHS.24.07.01НИП-0008/4.11.2024CT-0727/06.11.2024
• Study Type: observational
• Target: 281
• Locations: 1 country
• Sites: 14

Brief Summary

The mainstay of asthma treatment are ICSs, mostly and usually combined with LABA. In the past decade LAMA had been accepted as an add-on treatment for patients on GINA treatment Steps 4 and 5. Recently, RCTs proved the efficacy and safety of fixed triple combinations of moderate and high dose of ICS and LABA, LAMA in a very selected asthmatic population, resulting in the market authorization of these products. However, there is a lack of evidence on the real-world effectiveness of these therapies, especially with regards to improvement in symptom scores and quality of life.

Conditions

Asthma; Asthma Patients; Asthma Bronchiale

Keywords

Asthma therapy; Fixed triple inhalation treatment; Trimbow

Outcome Measures

Primary Outcomes (2)

• Asthma Control Test

  Change (improvement) of Asthma Control Test score, during the 6 months of treatment (Visit 3), compared to the score at baseline. A maximum score of 25 points indicates complete asthma control, while a score less than 16 indicates very poorly controlled asthma.

  6 months

• Asthma Control Test - 2

  The percentage of patients achieving an improvement in Asthma Control Test score of 3 points (MCID, minimum clinically important difference) or more, after the 6-month treatment (Visit 3) compared to baseline. A maximum score of 25 points indicates complete asthma control, while a score less than 16 indicates very poorly controlled asthma.

  6 months

Secondary Outcomes (4)

• Asthma Control Test change

  6 months

• HRQoL

  6 months

• Test of Adherence to Inhalers (TAI-12)

  6 months

• Lung function

  6 months

Study Arms (1)

Asthmatic patients switched to Trimbow (BDP/FF/G 172/5/9 μg)

Asthmatic patients switched to BDP/FF/G 172/5/9 μg before study enrollment or at the day of enrollment due to uncontrolled asthma (a) patients who experienced one or more asthma exacerbation in the previous year and uncontrolled despite the use of b1) LABA and high dose ICS or b2) LABA and high-dose ICS + LAMA multi-inhaler triple therapy.

Drug: BDP/FF/G (Beclomethasone diprprionate, formoterol fumarate, glycopyrronium bromide) 172/5/9 μg

Interventions

BDP/FF/G (Beclomethasone diprprionate, formoterol fumarate, glycopyrronium bromide) 172/5/9 μg DRUG

As this is a non-interventional study, it is accordance with routing clinical practice. The assignment of patients to Trimbow 172/5/9 mcg should be made independently from the study.

Asthmatic patients switched to Trimbow (BDP/FF/G 172/5/9 μg)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient inclusion will take place among patients having severe asthma at outpatient clinics in the selected and approved sites.

You may qualify if:

• Patients ≥ 18 years of age in ambulatory care
• Patients who are eligible for the use of Trimbow 172/5/9 μg pMDI according to the SmPC
• patients who experienced one or more asthma exacerbation in the previous year AND
• patients not adequately controlled according to the physician's clinical assessment despite the use of b1) LABA and high dose ICS OR b2) LABA and high-dose ICS + LAMA multi-inhaler triple therapy. FEV1\<80% at baseline. (spirometry performed at the visit 1 independently of the study or up to 30 days before the enrolment or within 3 days after Visit 1 is acceptable).

You may not qualify if:

• Participation in any clinical trial within 30 days prior to enrolment
• Patients hospitalized due to an exacerbation of their asthma within the last 4 weeks prior to enrolment.
• Diagnosis of COPD.
• Tuberculosis (active or anamnestic)
• Actual or previous use of biologics for asthma treatment in the past 12 months
• Hypersensitivity to the active substances or to any of the excipients listed in the SmPC
• Pregnancy and lactation.

Sponsors & Collaborators

• Chiesi Bulgaria: lead

Study Sites (14)

AIPSMCPP Dr. Elina Smilkova

Blagoevgrad, Bulgaria

Location

Medical Center Viva Phenix

Dobrich, Bulgaria

Location

Medical Center Hipocrat

Gabrovo, Bulgaria

Location

ASIMPIDPP Dr. Veselin Kalfov

Haskovo, Bulgaria

Location

Medical Center Denitza

Montana, Bulgaria

Location

IPASMC Dr. Kostadinka Sotirova

Pazardzhik, Bulgaria

Location

Group practice for specialized medical care - Asthma Center Pleven

Pleven, Bulgaria

Location

AIPSACA Dr. Talyat Cholak

Razgrad, Bulgaria

Location

AIPSMC Dr. Svetlan Mihaylov

Stara Zagora, Bulgaria

Location

Medical Center Third Policlinic

Stara Zagora, Bulgaria

Location

MHAT Svoge

Svoge, Bulgaria

Location

AIPSMCPP Dr. Nikolay Lichev V. Tarnovo

Veliko Tarnovo, Bulgaria

Location

Medical Center St. Ivan Rilski

Vidin, Bulgaria

Location

AIPSMCPP Dr. Bilyana Ivanova

Vratsa, Bulgaria

Location

MeSH Terms

Conditions

Asthma

Interventions

Formoterol Fumarate; Glycopyrrolate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Quaternary Ammonium Compounds; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yavor Y. Ivanov, Asso.Prof.

  Group practice for specialized medical care - Asthma Center Pleven

  STUDY CHAIR

• Neli L. Rodopska, Pharm.M.Sc

  Chiesi Bulgaria

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 22, 2025
• Study Start: February 1, 2025
• Primary Completion: January 5, 2026
• Study Completion: January 5, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BU (14)