To Investigate the Effects of Altering the Time of Day of Dosing (Morning or Evening) With Fluticasone Furoate 100 Micrograms Once Daily Administered Via a Dry Powder Inhaler in Subjects With Asthma
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 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.
How it ended
Completed on 2014-03-31, after 2013-03-31 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
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2014-03-31. 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: heartplacebouncontrolledstatussubject has
Phrases that lowered it: crossovercomparesinglefev1male -
Design: crossover (lowers risk) · Design
-
Sponsor's past termination rate: 4.9% (lowers risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Blinding: triple (raises risk) · Design
-
Number of arms: 3 (lowers risk) · Design
-
Sponsor's past trials: 1742 (raises risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 7.2% (lowers risk) · Drug's FDA history
-
Has a data monitoring committee: No (lowers risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Minimum age: 18 (raises risk) · Who can join
-
Disease area, neurology: No (lowers risk) · Disease area
-
Primary purpose: treatment (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 339 (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.
The trial
Design
- Phase
- 2
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 1
Who can join
- Minimum age
- 18
- Maximum age
- 70 (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
- 1742 (typical: 32)
- Sponsor's past termination rate
- 4.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 339 (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
- 376 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 260 (typical: 412.5)
- Drug's FAERS reports marked serious
- 80.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 7.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- respiratory, immunology
- Drugs matched to FDA substances
- fluticasone furoate
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
- A Study to Assess the Bronchodilator Effect of a Single Dose of Fluticasone Furoate (FF)/ Vilanterol (VI) 100/25 Micrograms (mcg) Combination When Administered in Adult Patients With Asthma NCT01837316 · started 2013 · scored riskier than 4% of active trials completed
- A Study in Asthmatic Patients to Determine if There is Any Difference in Dosing With Fluticasone Furoate/Vilanterol Inhalation Powder in the Morning or Evening on Lung Function NCT01287065 · started 2010 · scored riskier than 3% of active trials completed
- A Non-inferiority Study to Evaluate the Efficacy, Safety, and Tolerability of Combination Dry Powder of Fluticasone Propionate and Salmeterol (FSC) 250/50 Microgram (mcg) Twice Daily (BID) in Adults and Adolescents With Asthma NCT01978119 · started 2013 · scored riskier than 4% of active trials completed
- Phase 2a, AMP Challenge, Dose Escalation Study to Assess the Dose Response for Topical Efficacy and Systemic Activity in Asthmatic Subjects NCT02991859 · started 2017 · 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.