Dose Proportionality Study: Blood Levels of Fluticasone Furoate (FF) and Vilanterol (VI) Following Different Doses of FF/VI Via an Inhaler

NCT01213849 on ClinicalTrials.gov Phase 1 GlaxoSmithKline (industry) Started 2010-10-04 Completed

Among the lowest-risk 1% of active trials

Model scores of the 29,894 trials active now.

Model score 2% for any early termination, 0% 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 2010-11-25, after 2010-10-04 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 2010-11-25. 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: lungpotentialof studylast dosechild bearing
Phrases that lowered it: healthyscreeningsubjectvisitsingle dose
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Design: crossover (lowers risk) · Design
Phase: 1 (lowers risk) · Design
Sponsor's past termination rate: 4.4% (lowers risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 445 (raises risk) · Sponsor's track record
Drug's FAERS reports with a death: 4.3% (lowers risk) · Drug's FDA history
Has a data monitoring committee: No (lowers risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Blinding: none (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Minimum age: 18 (raises risk) · Who can join
Disease area, neurology: No (lowers risk) · Disease area
Primary purpose: basic science (raises risk) · Design
Sponsor's past trials: 1254 (raises risk) · Sponsor's track record
Maximum age: 65 (raises risk) · Who can join
Number of arms: 3 (lowers risk) · Design

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: crossover (typical: parallel)
Primary purpose: basic science (typical: treatment)
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 65 (typical: 71)
Sex: all
Accepts healthy volunteers: Yes (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 1254 (typical: 32)
Sponsor's past termination rate: 4.4% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 445 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 1
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 23 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 14 (typical: 412.5)
Drug's FAERS reports marked serious: 91.3% (typical: 85.6%)
Drug's FAERS reports with a death: 4.3% (typical: 15.9%)

Disease area and drugs

Disease areas: respiratory, immunology
Drugs matched to FDA substances: fluticasone furoate, vilanterol

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

Bioequivalence Study to Compare Fluticasone Furoate (FF) 1-strip Inhaler With FF 2-strip Inhaler and With FF/Vilanterol Combination NCT01485445 · started 2011 · scored riskier than 1% of active trials completed
Relovair PD PK in Chinese Healthy Subjects NCT01711463 · started 2012 · scored riskier than 2% of active trials completed
A Phase I Pharmacokinetic Study of Fluticasone Furoate /Umeclidinium Bromide/Vilanterol (100/62.5/25 Microgram [mcg]) After Single and Repeat Dose Administration From a Dry Powder Inhaler in Healthy Chinese Subjects NCT02837380 · started 2016 · scored riskier than 3% of active trials completed
Pharmacokinetic Profile of Four Formulations of Fluticasone Furoate (FF) Using Unit Dose Dry Powder Inhaler (UD-DPI) Compared With FF ELLIPTA® Presentation NCT02218723 · started 2014 · scored riskier than 1% of active trials completed
A Drug Interaction Study With Fluticasone Furoate/GW642444 Inhalation Powder and Ketoconazole NCT01165125 · started 2010 · scored riskier than 1% 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.