Clinical Equivalence Study of Fluticasone Propionate Nasal Spray, 50 mcg/Actuation vs. Flonase in Allergic Rhinitis Patients

NCT02246920 on ClinicalTrials.gov Phase 3 Teva Pharmaceuticals USA (industry) Started 2014-03-01 Terminated

Riskier than 3% of active trials

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 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

Terminated on 2014-07-14, after 2014-03-01 start.

Reason given by the sponsor: “other”

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 2014-07-14. 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: scorepatienttherapytotaleye
Phrases that lowered it: rhinitisnasalallergenallergicasthma
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Primary purpose: other (lowers risk) · Design
Phase: 3 (lowers risk) · Design
Drug's FAERS reports marked serious: 61.1% (lowers risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Sponsor type: industry (lowers risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Drug's FAERS reports with a death: 7.0% (lowers risk) · Drug's FDA history
Has a data monitoring committee: No (lowers risk) · Design
Blinding: quadruple (lowers risk) · Design
Number of arms: 3 (lowers risk) · Design
Sponsor's past trials: 166 (lowers risk) · Sponsor's track record
Disease area, neurology: No (lowers risk) · Disease area
Maximum age: not given (lowers risk) · Who can join
Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
Drug's FAERS reports in the prior 12 months: 7749 (raises 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: other (typical: treatment)
Blinding: quadruple (typical: none)
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 2 (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: 166 (typical: 32)
Sponsor's past termination rate: 0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 1 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 2 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 32460 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 7749 (typical: 412.5)
Drug's FAERS reports marked serious: 61.1% (typical: 85.6%)
Drug's FAERS reports with a death: 7.0% (typical: 15.9%)

Disease area and drugs

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

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Clinical Equivalence Study of Mometasone Nasal Spray NCT01850823 · started 2013 · scored riskier than 5% of active trials completed
A Study to Assess Efficacy and Safety of Nasacort® Nasal Spray in Comparison With Flixonase® Nasal Spray in Adults Suffering From Perennial Allergic Rhinitis (PAR) NCT03317015 · started 2016 · scored riskier than 4% of active trials completed
A Pilot Study In Adults And Adolescents With Irritant (Non-Allergic) Rhinitis NCT00730756 · started 2008 · scored riskier than 6% of active trials completed
Study to Compare the Therapeutic Equivalence of Mometasone Furoate Nasal Spray, 50 mcg With Nasonex Nasal Spray in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis NCT02125253 · started 2014 · 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.