Actively Recruiting

Age: 18Years +
All Genders
ID06966271

Investigation of the Relationship Between the Respiratory Profile of Patients With Obstructive Pulmonary Disease and the Effectiveness of the Inhalation Therapies

Led by Tradeflex Ltd · Updated on 2025-05-11

150

Participants Needed

7

Research Sites

13 weeks

Total Duration

On this page

Sponsors

T

Tradeflex Ltd

Lead Sponsor

M

Medisol Development Kft.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating how the breathing patterns of adults with asthma or chronic obstructive pulmonary disease (COPD) affect the delivery and effectiveness of inhaled medications. The study aims to use computer modeling based on individual lung function tests to simulate how different inhalers deliver medication to the lungs. This observational study hopes to help doctors choose the best inhaler device for each patient by understanding how breathing profiles interact with inhaler types and resistance levels. Participants will undergo a regular pulmonary function test, which records their breathing curves. Using this data, a computer program models drug deposition in the lungs for various inhalers with different flow rates and resistances. No changes to current treatments are made during the study. The study also evaluates the patients’ inhaler technique and suggests ways to improve device use to optimize medication delivery. The study runs from January 2025 to December 2025. During the study, participants will provide breathing test data and complete questionnaires about their inhaler use. Researchers will analyze this information to assess inhalation effectiveness and device suitability. The primary outcome is the correlation between respiratory function and modeled drug deposition in the lungs. The study includes monitoring inhalation techniques and aims to improve future care by guiding personalized inhaler selection. Participation requires adults with asthma or COPD who can perform the breathing test and use their inhaler properly.

CONDITIONS

Brief Title

Investigation of the Respiratory Profile of Patients With Obstructive Pulmonary Disease (ASTHMA, COPD)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed obstructive pulmonary disease (asthma or COPD) confirmed by a pulmonologist
  • Proper use of inhalation device after training
  • Routine pulmonary function test performed during medical visit
  • Ambulatory (non-hospitalized) patient
  • Age over 18 years
  • Mentally competent and able to consent
Not Eligible

You will not qualify if you...

  • Failure to meet any of the inclusion criteria
  • Inability to complete the relevant parts of the questionnaire
  • Refusal to consent to participation
  • Presence of untreated severe chronic illness
  • Invalid or improperly conducted pulmonary function test

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Approximately 7 months

Participants undergo pulmonary function tests and inhalation technique assessments to evaluate breathing profiles and inhalation drug deposition.

1 to 2 visits during medical appointments

Trial Site Locations

Total: 7 locations

1

Országos Korányi Pulmonológiai Intézet

Budapest, Hungary

Not Yet Recruiting

2

Csornai Margit Kórház Pulmonológiai és Allergológia Szakambulancia

Csorna, Hungary

Not Yet Recruiting

3

Debreceni Egyetem Tüdőgyógyászati Klinika

Debrecen, Hungary

Not Yet Recruiting

4

Dunakeszi-SZTK Nonprofit Kft. Tüdőgyógyászat

Dunakeszi, Hungary

Not Yet Recruiting

5

Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház

Győr, Hungary

Not Yet Recruiting

6

• Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ Tüdőgyógyászati Klinika

Szeged, Hungary

Not Yet Recruiting

7

Református Pulmonológiai Centrum

Törökbálint, Hungary

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Numerical simulation of the effect of inhalation parameters, gender, age and disease severity on the lung deposition of dry powder aerosol drugs emitted by Turbuhaler®, Breezhaler® and Genuair® in COPD patients.

Alpár Horváth, Árpád Farkas, Annamária Szipőcs...

https://pubmed.ncbi.nlm.nih.gov/32836137