Evaluating how inhaled medications work for asthma and COPD patients
Investigation of the Relationship Between the Respiratory Profile of Patients With Obstructive Pulmonary Disease and the Effectiveness of the Inhalation Therapies
This study is testing how well inhaled medications work for adults with asthma and COPD by looking at their breathing patterns to see if we can improve how they use their inhalers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tradeflex Ltd Industry-sponsored |
| Locations | 7 sites (Budapest and 6 other locations) |
| Trial ID | NCT06966271 on ClinicalTrials.gov |
What this trial studies
The OPTIPULM study investigates the relationship between patients' breathing profiles and the effectiveness of inhaled therapies for asthma and chronic obstructive pulmonary disease (COPD). By analyzing pulmonary function test data, the study aims to model and estimate how well inhaled medications deposit in the lungs based on individual inhalation techniques and device characteristics. It also seeks to optimize inhaler use by providing recommendations tailored to each patient's breathing patterns. This observational study focuses on adult patients diagnosed with these conditions to improve treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with a confirmed diagnosis of asthma or COPD who can properly use an inhalation device.
Not a fit: Patients with untreated severe chronic illnesses or those unable to complete the necessary assessments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective inhalation therapies tailored to individual patient needs, improving overall management of asthma and COPD.
How similar studies have performed: While the approach of modeling lung deposition based on individual breathing profiles is innovative, similar studies have shown that optimizing inhalation techniques can improve treatment outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Primary Outcome Measure: Estimated Lung Deposition of Inhaled Medication (% of Emitted Dose): The proportion of the inhaled drug dose predicted to deposit in the lungs, calculated via computer modeling using each participant's individual pulmonary function curve and inhalation parameters. Inclusion criteria: * 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. Exclusion criteria: * 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.
Where this trial is running
Budapest and 6 other locations
- Országos Korányi Pulmonológiai Intézet — Budapest, Hungary (Not_yet_recruiting)
- Csornai Margit Kórház Pulmonológiai és Allergológia Szakambulancia — Csorna, Hungary (Not_yet_recruiting)
- Debreceni Egyetem Tüdőgyógyászati Klinika — Debrecen, Hungary (Not_yet_recruiting)
- Dunakeszi-SZTK Nonprofit Kft. Tüdőgyógyászat — Dunakeszi, Hungary (Not_yet_recruiting)
- Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház — Győr, Hungary (Not_yet_recruiting)
- • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ Tüdőgyógyászati Klinika — Szeged, Hungary (Not_yet_recruiting)
- Református Pulmonológiai Centrum — Törökbálint, Hungary (Recruiting)
Study contacts
- Principal investigator: János Varga, Prof. — Semmelweis University
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.