Study to Investigate the Dose Response, Safety and Efficacy of Nebulized EP-101(SUN101) in Patients With Chronic Obstructive Pulmonary Disease (COPD): GOLDEN-1 Study

Model scores of the 29,894 trials active now.

Model score 6% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 10% of the time (528 trials).

Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2011-12-31. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

• Design: crossover (lowers risk) · Design
• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: uncontrolledhoursplacebofailuremyocardial
  Phrases that lowered it: screeningsubjectsmoderatedaypharmacokinetic
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
• Phase: 2 (raises risk) · Design
• Drug's FAERS reports marked serious: 45.0% (lowers risk) · Drug's FDA history
• Number of arms: 7 (lowers risk) · Design
• Minimum age: 40 (lowers risk) · Who can join
• Blinding: quadruple (lowers risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Drug's FAERS reports with a death: 9.5% (lowers risk) · Drug's FDA history
• Has a data monitoring committee: No (lowers risk) · Design
• Disease area, neurology: No (lowers risk) · Disease area
• Maximum age: 75 (raises risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Sponsor's past trials: 2 (raises risk) · Sponsor's track record

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

• A Phase 2a Study to Assess Safety, Daily Symptoms, PK, and Biomarkers of YPL-001 in COPD Patients NCT02272634 · started 2015 · scored riskier than 24% of active trials completed
• A Study of the Efficacy and Safety of EP-101 ( (SUN101) in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease NCT01706536 · started 2012 · scored riskier than 14% of active trials completed
• Assessment of the Safety and Ability of a Once-a-day Dose of an Orally Inhaled Medicine [i.e., Glycopyrrolate Inhalation Solution = GIS] to Improve Airflow in the Lungs When Delivered Using an eFlow Nebulizer in Patients With Chronic Obstructive Pulmonary Disease (COPD) NCT02948582 · started 2010 · scored riskier than 6% of active trials completed
• Efficacy and Safety of Twice Daily 60mg AZD9668 in COPD for 12 Weeks in Patients on Background Budesonide/Formoterol NCT01023516 · started 2009 · scored riskier than 9% of active trials completed
• Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) NCT00629239 · started 2008 · scored riskier than 8% of active trials completed

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.