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Clinical Trials/NCT05743608
NCT05743608
Completed
Not Applicable

Non-interventional, Open-label, Prospective Study to Assess the Effectiveness of BDP/FF/G Fixed Triple Inhalation Powder on Symptom Scores in Moderate to Severe COPD Patients, Uncontrolled With Inhaled Dual Therapies (LABA/LAMA or ICS/LABA)

Chiesi Hungary Ltd.39 sites in 1 country1,336 target enrollmentMarch 29, 2023
ConditionsCOPD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COPD
Sponsor
Chiesi Hungary Ltd.
Enrollment
1336
Locations
39
Primary Endpoint
COPD Assessment Test (CAT)
Status
Completed
Last Updated
7 months ago

Overview

Brief Summary

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:

  • Treatment's effect on quality of life
  • Treatment's effect on lung function Participants will be assessed according to routine clinica practice, without any additional intervention.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 29, 2023
End Date
May 5, 2025
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Chiesi Hungary Ltd.
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

COPD Assessment Test (CAT)

Time Frame: 6 months

Change in symptom scores (COPD Assessment Test - CAT) after six months of treatment. On a scale of 0-40

Secondary Outcomes

  • Responders(6 months)
  • Health Related Quality of Life (HRQoL) - questions(6 months)
  • Symptoms(6 months)
  • Saturation(6 months)
  • HRQoL - VAS(6 months)
  • Night-time symptoms(6 months)
  • mMRC(6 months)
  • Lung function - Forces Expiratory flow in 1 second (FEV1)(6 months)
  • Lung function Forced Vital Capacity (FVC)(6 months)
  • Adherence(6 months)

Study Sites (39)

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