Practical Considerations for Optimizing Endpoints in Idiopathic Pulmonary Fibrosis (IPF) Clinical Trials
This article summarizes a panel discussion held during the 2025 IPF Summit, in which representatives from PureTech Health and Vitalograph examined operational challenges and solutions in the conduct of idiopathic pulmonary fibrosis (IPF) clinical trials. The discussion focused in particular on strategies to optimize spirometry and other endpoints to ensure data reliability and reproducibility.
Background
Clinical development in IPF presents inherent complexities. The disease is relatively uncommon, frequently misdiagnosed, and most patients are older with multiple comorbidities.
Within this context, the selection and execution of endpoints are pivotal. Forced vital capacity (FVC) measured by spirometry remains the most widely accepted and regulatory-preferred endpoint for assessing disease progression in IPF. The acquisition of high-quality, reproducible spirometry data requires careful study planning and oversight. Variability can arise from heterogeneity in equipment, differences in site staff training, patient performance and comprehension, and delays in feedback. Addressing these operational factors is therefore essential to ensure the reliability of trial outcomes.
Opportunities for Further Clinical Trial Optimization
With the ELEVATE trial experience, PureTech recommends sponsors of IPF trials to focus on four areas in FVC measurement:
Equipment standardization – Ensuring uniform spirometry devices across all sites to further minimize variability and streamline training.
Expanded real-time monitoring – Broader deployment of tools that provide immediate quality feedback to coordinators at every visit.
Enhanced scalability of patient support – Building on travel and lodging support with additional resources to reduce participation barriers across a larger, multinational population.
Optimized communication pathways – Establishing even more structured, single-channel communication to ensure sites receive timely, unified guidance as trial complexity increases.
These enhancements build upon the successful strategies of ELEVATE while enabling efficiency and consistency in IPF trials.
Spirometry Quality: Perspectives from Vitalograph
PureTech’s approach in ELEVATE was effective in achieving high-quality, reproducible spirometry data. It required significant sponsor oversight and hands-on management. PureTech did not partner with Vitalograph during the ELEVATE-IPF trial. Vitalograph’s decades of experience in centralized spirometry over-reading highlight how specialized vendors can ease this operational burden. Their data indicate that while 85–90% of sessions achieve grade A or B quality, repeatability issues and patient limitations are persistent challenges.
Practical interventions such as real-time alerts, quick-reference tools, and expedited over-reads at critical visits can help sponsors achieve the same quality outcomes while reducing site strain and sponsor workload. In this way, partnering with vendors such as Vitalograph offers a scalable solution for ensuring data integrity in Phase 3 and beyond.
Conclusion
IPF clinical trials present unique operational challenges; however, the ELEVATE-IPF study demonstrated that these challenges can be effectively mitigated through proactive planning, patient- and coordinator-centered support, and rigorous execution. The learnings from Phase 2b are directly informing the design of PureTech’s Phase 3 program, with a focus on further standardization, scalability, and patient-centricity.
As the field advances, continued attention to the operational aspects of spirometry will be critical to ensuring data of the highest quality — and, ultimately, to accelerating the development of more effective therapeutic options for patients with IPF.