Status:
RECRUITING
Investigation of the Respiratory Profile of Patients With Obstructive Pulmonary Disease (ASTHMA, COPD)
Lead Sponsor:
Tradeflex Ltd
Collaborating Sponsors:
Medisol Development Kft.
Conditions:
Asthma Bronchiale
COPD
Eligibility:
All Genders
18+ years
Brief Summary
The primary aim of the OPTIPULM study is the evaluation of recorded pulmonary function curves and, based on them, the computer modelling of lung deposition for the individually used or potentially app...
Detailed Description
Study Title: Assessment of the Relationship Between Inhalation Therapy Effectiveness and Breathing Profiles in Patients with Obstructive Pulmonary Diseases (OPTIPULM) The primary goal of this observ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06966271
Start Date
January 1 2025
End Date
December 30 2025
Last Update
May 11 2025
Active Locations (7)
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1
Országos Korányi Pulmonológiai Intézet
Budapest, Hungary
2
Csornai Margit Kórház Pulmonológiai és Allergológia Szakambulancia
Csorna, Hungary
3
Debreceni Egyetem Tüdőgyógyászati Klinika
Debrecen, Hungary
4
Dunakeszi-SZTK Nonprofit Kft. Tüdőgyógyászat
Dunakeszi, Hungary