QVA vs. Salmeterol/Fluticasone, 52-week Exacerbation Study, FLAME (EFfect of Indacaterol Glycopyronium Vs Fluticasone Salmeterol on COPD Exacerbations)

NCT01782326 on ClinicalTrials.gov Phase 3 Novartis Pharmaceuticals (industry) Started 2013-07-31 Completed

Riskier than 22% of active trials

Model scores of the 29,894 trials active now.

Model score 12% for any early termination, 2% 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 2015-09-30, after 2013-07-31 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 2015-09-30. 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

Sponsor's past termination rate: 13.1% (raises risk) · Sponsor's track record
Minimum age: 40 (lowers risk) · Who can join
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 3 (lowers risk) · Design
Blinding: triple (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Design: parallel (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Has a data monitoring committee: No (lowers risk) · Design
Sponsor's past trials: 535 (raises risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports marked serious: 92.4% (raises risk) · Drug's FDA history
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: doublehistoryclinically significantcontrolledlong
Phrases that lowered it: patientscopdlungweekstherapy
Drug's FAERS reports with a death: 19.3% (lowers risk) · Drug's FDA history
Number of arms: 2 (raises risk) · Design

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: 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: 40 (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: 535 (typical: 32)
Sponsor's past termination rate: 13.1% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 306 (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: 145 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 70 (typical: 412.5)
Drug's FAERS reports marked serious: 92.4% (typical: 85.6%)
Drug's FAERS reports with a death: 19.3% (typical: 15.9%)

Disease area and drugs

Disease areas: respiratory
Drugs matched to FDA substances: glycopyrronium, indacaterol

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

Effect of QVA149 Versus NVA237 and Tiotropium on Chronic Obstructive Pulmonary Disorder (COPD) Exacerbations NCT01120691 · started 2010 · scored riskier than 4% of active trials completed
Non Inferiority of Fixed Combination of Beclomethasone Dipropionate (BDP) + Formoterol Fumarate (FF) + Glycopyrronium Bromide (GB) Versus Combination of Fluticasone Furoate (FlF)/Vilanterol (VI) + Tiotropium Bromide in Chronic Obstructive Pulmonary Disease (COPD) NCT02467452 · started 2015 · scored riskier than 7% of active trials completed
Foster® pMDI (CHF 1535) Versus Symbicort® Turbohaler in COPD Patient (FORSYYN) NCT03888131 · started 2018 · scored riskier than 8% of active trials completed
A Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination CHF 5993 With the Fixed Dose Dual Combination CHF 1535 in Subjects With COPD NCT04320342 · started 2022 · scored riskier than 7% of active trials completed
Active Controlled Trial of CHF5993 Pressurized Metered-dose Inhaler ( pMDI) vs Symbicort®Turbuhaler® in Patients With Chronic Obstructive Pulmonary Disease ( COPD) (TRIVERSYTI) NCT03197818 · started 2016 · 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.