Clinical Trial

Longitudinal Outcomes of Patients With Group 3 Pulmonary Hypertension Treated With Iloprost

Study acronym: AirFly
Completed
View on ClinicalTrials.gov →
Summary
This observational real-world study aims to evaluate the longitudinal clinical outcomes of adult patients with Group 3 pulmonary hypertension (PH), associated with chronic lung diseases such as interstitial lung disease, who are treated with inhaled iloprost in routine clinical practice. Treatment options for Group 3 PH remain limited, and the use of pulmonary vasodilators is controversial due to potential worsening of gas exchange. Inhaled iloprost may provide a more selective approach by targeting well-ventilated lung regions. However, real-world data on its use in this population are scarce. The primary objective of this study is to assess changes in clinical risk status over time using the COMPERA 2.0 four-stratum risk model. Secondary objectives include describing patient characteristics, treatment patterns, and the evolution of functional parameters and biomarkers, as well as documenting relevant clinical events such as hospitalizations, treatment escalation, and discontinuation. The study will retrospectively analyze data from approximately 50 adult patients with confirmed Group 3 PH who received inhaled iloprost as part of their routine care in a specialized pulmonary hypertension center. No additional patient contact or interventions will occur.
Protocol Amendment History 4 changes
critical Trial status changed: Not Yet Recruiting → Completed 2026-06-25
notable Enrollment increased: 50 -> 72 participants 2026-06-25
notable Primary completion moved earlier: 2027-07-01 -> 2026-06-01 2026-06-25
minor Completion moved earlier: 2027-07-01 -> 2026-06-01 2026-06-25
Trial Details
NCT Number NCT07478094
Lead Sponsor University of Sao Paulo General Hospital
Conditions Pulmonary Hypertension Due to Lung Diseases
Enrollment 72 participants
Start Date 2026-05-01
Primary Completion 2026-06-01 (estimated)
Study Completion 2026-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-24