Safety Study of Albuterol Spiromax® in Subjects With Asthma

NCT01698320 on ClinicalTrials.gov Phase 3 Teva Branded Pharmaceutical Products R&D, Inc. (industry) Started 2012-10-31 Completed

Riskier than 12% of active trials

Model scores of the 29,894 trials active now.

Model score 9% 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 2013-12-31, after 2012-10-31 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

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2013-12-31. 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: subjectacutedefineddiagnosiscell
Phrases that lowered it: asthmatrialperiodvisitsmoking
Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 13.2% (raises risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Phase: 3 (lowers risk) · Design
Drug's FAERS reports with a death: 9.5% (lowers risk) · Drug's FDA history
Blinding: quadruple (lowers risk) · Design
Drug's FAERS reports marked serious: 70.1% (lowers risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Has a data monitoring committee: No (lowers risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 18 (lowers risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Sponsor's past trials: 68 (lowers risk) · Sponsor's track record
Disease area, neurology: No (lowers risk) · Disease area

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: 2
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: quadruple (typical: 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: 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: 68 (typical: 32)
Sponsor's past termination rate: 13.2% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 18 (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: 38698 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 8111 (typical: 412.5)
Drug's FAERS reports marked serious: 70.1% (typical: 85.6%)
Drug's FAERS reports with a death: 9.5% (typical: 15.9%)

Disease area and drugs

Disease areas: respiratory, immunology
Drugs matched to FDA substances: albuterol

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

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A Study of the Effectiveness and Safety of Different Doses of Fluticasone Propionate Taken From a Dry Powder Inhaler in Adolescents and Adults Who Have Asthma That is Not Controlled by Asthma Medications Not Containing Steroids NCT01479621 · started 2012 · scored riskier than 9% of active trials completed
A 12-week Study to Compare the Efficacy and Safety of Albuterol Spiromax® Versus a Placebo in People 12 Years and Older With Persistent Asthma NCT01424813 · started 2012 · scored riskier than 9% 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.