An Efficacy and Safety Study of Fluticasone Furoate/Vilanterol 100/25 Microgram (mcg) Inhalation Powder, Fluticasone Propionate/Salmeterol 250/50 mcg Inhalation Powder, and Fluticasone Propionate 250 mcg Inhalation Powder in Adults and Adolescents With Persistent Asthma
Model scores of the 29,894 trials active now.
Model score 5% 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 in 2015 or later: the model never saw it during training.
How it ended
Completed on 2016-11-25, after 2015-03-01 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
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 2016-11-25. 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
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: diseasedeterminecombinationsubject mustprior
Phrases that lowered it: asthmainhalerfluticasonevisitinhalation -
Accepts healthy volunteers: No (raises risk) · Who can join
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Drug's FAERS reports marked serious: 55.7% (lowers risk) · Drug's FDA history
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Phase: 3 (lowers risk) · Design
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Drug's FAERS reports with a death: 6.4% (lowers risk) · Drug's FDA history
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Sponsor's past trials: 2066 (raises risk) · Sponsor's track record
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Sponsor's past termination rate: 5.7% (lowers risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Maximum age: not given (lowers risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Number of arms: 3 (lowers risk) · Design
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Blinding: double (raises risk) · Design
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Responsible party: sponsor (lowers risk) · Design
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Drug's FAERS reports before start: 84567 (lowers risk) · Drug's FDA history
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
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 10 (typical: 1)
Who can join
- Minimum age
- 12 (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
- 2066 (typical: 32)
- Sponsor's past termination rate
- 5.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 283 (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
- 84567 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 30658 (typical: 412.5)
- Drug's FAERS reports marked serious
- 55.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 6.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- respiratory, immunology
- Drugs matched to FDA substances
- fluticasone, fluticasone furoate, fluticasone propionate, salmeterol, salmeterol xinafoate, 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
- An Efficacy and Safety Study of Fluticasone Furoate/Vilanterol (FF/VI) 200/25 Microgram (mcg) , FF/VI 100/25 mcg, and FF 100 mcg in Adults and Adolescents With Persistent Asthma. NCT01686633 · started 2012 · scored riskier than 6% of active trials completed
- Safety and Efficacy Study of Fluticasone Furoate/Vilanterol (FF/VI) Fixed Dose Combination (FDC) Compared to FF Alone in Subjects With Asthma NCT03248128 · started 2017 · scored riskier than 7% of active trials completed
- Evaluating the Efficacy and Safety of Fluticasone Furoate/Vilanterol Trifenatate in the Treatment of Asthma in Adolescent and Adult Subjects of Asian Ancestry. NCT01498679 · started 2012 · scored riskier than 7% of active trials completed
- Evaluating the Efficacy and Safety of Fluticasone Furoate/Vilanterol Trifenatate in the Treatment of Asthma in Adolescent and Adult Subjects of Asian Ancestry NCT01498653 · started 2012 · scored riskier than 6% of active trials completed
- A Study of the Effectiveness and Safety of Different Doses of Fluticasone Propionate Taken From a Dry Powder Inhaler (Puffer) in Adolescents and Adults Who Have Asthma That is Not Controlled by High Dose Inhaled Corticosteroid Asthma Medications NCT01576718 · started 2012 · 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.