Phase 2a, AMP Challenge, Dose Escalation Study to Assess the Dose Response for Topical Efficacy and Systemic Activity in Asthmatic Subjects
Model scores of the 29,894 trials active now.
Model score 6% 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 in 2015 or later: the model never saw it during training.
How it ended
Completed on 2018-12-20, after 2017-02-09 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 2018-12-20. 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: heartplacebochroniccarcinomatherapy
Phrases that lowered it: asthmascreeningvisitperiodfev1 -
Design: crossover (lowers risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past trials: 2351 (raises risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
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Drug's FAERS reports marked serious: 52.2% (lowers risk) · Drug's FDA history
-
Sponsor's past termination rate: 6.0% (lowers risk) · Sponsor's track record
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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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Drug's FAERS reports with a death: 5.5% (lowers risk) · Drug's FDA history
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Blinding: quadruple (lowers risk) · Design
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Number of arms: 12 (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Maximum age: 65 (raises risk) · Who can join
-
Disease area, neurology: No (lowers risk) · Disease area
-
Minimum age: 18 (raises risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 225 (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
- 12 (typical: 2)
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 65 (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
- 2351 (typical: 32)
- Sponsor's past termination rate
- 6.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 225 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 4 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 153469 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 36225 (typical: 412.5)
- Drug's FAERS reports marked serious
- 52.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 5.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- respiratory, immunology
- Drugs matched to FDA substances
- budesonide, fluticasone, fluticasone furoate, fluticasone propionate
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
- 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 NCT01808339 · started 2013 · scored riskier than 4% of active trials completed
- 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 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
- A Study to Compare the Efficacy and Safety of Fluticasone Furoate (FF) 100 mcg Once Daily With Fluticasone Propionate (FP) 250 mcg Twice Daily (BD) and FP 100 mcg BD in Well-controlled Asthmatic Japanese Subjects NCT02094937 · started 2014 · scored riskier than 8% of active trials completed
- Inhalation of Corticosteroids in Smoking and Non-smoking Asthmatics. NCT01400906 · started 2011 · scored riskier than 4% 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.