An observational study in COPD, sponsored by Chiesi Hungary Ltd.. Completed at 39 sites in Hungary. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2025-09-09.
Sponsored by Chiesi Hungary Ltd. · Observational
The goal of this observational study is to measure improvement in health related quality of life in moderate to severe COPD patients treated with Trimbow inhalation powder. The main question[s] it aims to answer are:
COPD is a severe and very common disease affecting a large proportion of smokers (and even non-smokers) all around the world. With the large prevalence and wide spectrum of disease presentation (from limited obstruction to life threatening conditions) there is a need for differentiated, targeted approach to therapy. For this purpose, plenty of inhaler devices had been developed. Chiesi is the only company which provides fix triple combinations in both DPI and pMDI formulations. While there is ample data from multiple studies on the real-world effectiveness of the pMDI, there is a relevant gap in our knowledge on the RWE effectiveness of the DPI device Trimbow dry powder inhaler is a novel extrafine, single inhaler triple therapy, in a state of the art dry powder inhaler, which is easy to use and may provide additional benefit to a large proportion of COPD patients. However, there are only a limited number of studies assessing its effectiveness, especially in patients with moderate airflow obstruction. Providing more real-world evidence that Trimbow® dry powder inhaler is an effective and preferred treatment option in reducing symptoms and improving lung function in all COPD patients, would help pulmonologists choose the most suitable treatment option for a very wide array of patients.
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's enrollment of 1,336 is above the median of 180 across 1,066 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Chiesi Hungary Ltd. is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Moderate to severe COPD patients who are uncontrolled on either LABA/LAMA or ICS/LABA fixed dose dual combination therapy, and had been switched to Trimbow dry powder inhaler prior to study inclusion
Eligibility to Trimbow 88/5/9 µg inhalation powder treatment according to SmPC:
uncontrolled despite fixed dual combination treatment (LABA/LAMA or ICS/LABA):
Exclusion criteria:
Patients above the age of 35 years, who had been diagnosed with COPD for over a year by a pulmonologists specialist. Having a moderate or severe obstruction (30%≤FEV1\<80%) and are uncontrolled despite fixed dual combination treatment (LABA/LAMA or ICS/LABA). Therapy was changed to Trimbow® 88/5/9 µg inhalation powder maximum 1 week prior to or on the day of study inclusion and irrespective of study entry (escalation of symptomatic patient to fixed triple combination as per treatment protocol)
COPD Assessment Test (CAT)
Change in symptom scores (COPD Assessment Test - CAT) after six months of treatment. On a scale of 0-40
Time frame: 6 months
Lung function - Forces Expiratory flow in 1 second (FEV1)
Change in FEV1 values after inhalation during 6 months of treatment compared to baseline.
Time frame: 6 months
Lung function Forced Vital Capacity (FVC)
Change in FVC values after inhalation during 6 months of treatment compared to baseline.
Time frame: 6 months
Responders
Percentage of patients with a change from baseline 2\< in CAT after 6 months of treatment compared to baseline (assessment of response to therapy).
Time frame: 6 months
Health Related Quality of Life (HRQoL) - questions
To assess changes in quality of life in EQ-5D-3L domains after 6 months of treatment compared to baseline. Scale on a level of three
Time frame: 6 months
HRQoL - VAS
To assess changes in quality of life in EQ-5D visual analogue scale (VAS) after 6 months of treatment compared to baseline. Scale from 0-100
Time frame: 6 months
Symptoms
To assess changes in frequency of cough and sputum production after 6 months of treatment compared to baseline.
Time frame: 6 months
Saturation
To assess changes in arterial oxygenation compared to baseline oxigen saturation (SpO2) after 6 months of treatment.
Time frame: 6 months
Adherence
To assess changes in adherence to inhaler treatment according to the TAI (Test of adherence to inhalers) questionnaire after 6 months of treatment compared to baseline. Scale is from 12-54
Time frame: 6 months
Night-time symptoms
To assess changes in the frequency of night-time symptoms after 6 months of treatment compared to baseline.
Time frame: 6 months
mMRC
To assess changes in dyspnoea severity using the mMRC (modified Medical Research Council) questionnaire after 6 months of treatment compared to baseline. Scale from 1-4
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pulmonary Disease, Chronic Obstructive→
Chiesi Hungary Ltd.