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Characterization of Lung Function Profile of Inhaled Tiotropium + Olodaterol Fixed Dose Combination Compared to Fluticasone Propionate + Salmeterol Fixed Dose Combination in COPD Patients

NCT01969721 on ClinicalTrials.gov Phase 3 Boehringer Ingelheim (industry) Started 2013-10-31 Completed
Riskier than 3% of active trials
this trial: 4% 0% 36%

Model scores of the 29,894 trials active now.

Model score 4% 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 (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.

How it ended

Completed on 2015-02-28, after 2013-10-31 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

0% 25% 50% 75% 100% 0123456 yr completed 96% terminated 4%

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2015-02-28. 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

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
3 (typical: 2)
Number of arms
4 (typical: 2)
Allocation
randomized
Design
crossover (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
not given (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
207 (typical: 32)
Sponsor's past termination rate
4.8% (typical: 9.9%)
Trials the sponsor started in the prior 2 years
134 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history
6 (typical: 1)
Drug has FAERS history
Yes (typical: 64% yes)
Drug's FAERS reports before start
94576 (typical: 2148)
Drug's FAERS reports in the prior 12 months
21764 (typical: 412.5)
Drug's FAERS reports marked serious
49.4% (typical: 85.6%)
Drug's FAERS reports with a death
7.4% (typical: 15.9%)

Disease area and drugs

Disease areas
respiratory
Drugs matched to FDA substances
fluticasone, fluticasone propionate, olodaterol, salmeterol, salmeterol xinafoate, tiotropium

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

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.