BI 113608 Administered as Tablets Twice Daily Over 4 Weeks in Patients With Chronic Obstructive Pulmonary Disease Associated With Chronic Bronchitis

NCT01958008 on ClinicalTrials.gov Phase 1 Boehringer Ingelheim (industry) Started 2013-09-30 Completed

Riskier than 8% of active trials

Model scores of the 29,894 trials active now.

Model score 7% 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 6% of the time (355 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.

How it ended

Completed on 2014-05-31, after 2013-09-30 start.

The score above never used this outcome: 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.

Termination over time, as the model saw it at the start

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2014-05-31. 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.

What moved the score

Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: definedsyndromechildbearing potentialcell carcinomaresection
Phrases that lowered it: copdpatients whorelevantbiinvestigator
Accepts healthy volunteers: No (raises risk) · Who can join
Minimum age: 40 (lowers risk) · Who can join
Sponsor's past termination rate: 5% (lowers risk) · Sponsor's track record
Phase: 1 (lowers risk) · Design
Has a data monitoring committee: not given (lowers risk) · Design
Design: single group (raises risk) · Design
Trials the sponsor started in the prior 2 years: 131 (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Primary purpose: treatment (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Number of arms: 3 (lowers risk) · Design
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
Sponsor's past trials: 200 (lowers risk) · Sponsor's track record
Disease area, neurology: No (lowers risk) · Disease area
Maximum age: 80 (raises risk) · Who can join

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.

The trial

Design

Phase: 1 (typical: 2)
Number of arms: 3 (typical: 2)
Allocation: randomized
Design: single group (typical: parallel)
Primary purpose: treatment
Blinding: double (typical: none)
Has a data monitoring committee: not given (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 40 (typical: 18)
Maximum age: 80 (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 200 (typical: 32)
Sponsor's past termination rate: 5% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 131 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 0 (typical: 1)
Drug has FAERS history: No (typical: 64% yes)
Drug's FAERS reports before start: 0 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 0 (typical: 412.5)
Drug's FAERS reports marked serious: no FAERS history (typical: 85.6%)
Drug's FAERS reports with a death: no FAERS history (typical: 15.9%)

Disease area and drugs

Disease areas: respiratory
Drugs matched to FDA substances: none matched

Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.

Similar finished trials

Safety, Tolerability and Pharmacokinetics and Effect on Inflammation of Oral BI 1026706 in Patients With COPD NCT02642614 · started 2016 · scored riskier than 7% of active trials completed
Clinical Study to Assess the Mode of Action of QBW251 in Patients With Chronic Obstructive Pulmonary Disease (COPD) NCT04268823 · started 2020 · scored riskier than 47% of active trials terminated
Combination of Orally Inhaled BI1744CL/Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease ( COPD) NCT00696020 · started 2008 · scored riskier than 4% of active trials completed
A Phase 1b Study of PUR1800 in Patients With COPD NCT04759807 · started 2021 · scored riskier than 4% of active trials completed
Efficacy, Pharmacokinetics (PK), Safety and Tolerability Study of Inhaled AZD8871 NCT02971293 · started 2016 · scored riskier than 5% 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.