A Randomized-Controlled Trial of Inhaled Hypertonic Saline (7%) to Evaluate the Lung Clearance Index
Model scores of the 29,894 trials active now.
Model score 10% for any early termination, 8% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 21% of the time (143 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 2014-09-30, after 2011-11-30 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 2014-09-30. 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
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Design: crossover (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: days ofuseweekschildreninvestigational drug
Phrases that lowered it: lungfev1evaluate theto evaluatescreening -
Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 39.7% (raises risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor's past termination rate: 7.8% (lowers risk) · Sponsor's track record
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Blinding: double (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 44 (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 96.3% (raises risk) · Drug's FDA history
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Disease area, neurology: No (lowers risk) · Disease area
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Number of arms: 2 (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Sponsor's past trials: 77 (lowers risk) · Sponsor's track record
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Collaborators: 0 (raises risk) · Design
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Responsible party: principal investigator (lowers 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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 6 (typical: 18)
- Maximum age
- 18 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 77 (typical: 32)
- Sponsor's past termination rate
- 7.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 44 (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
- 136 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 27 (typical: 412.5)
- Drug's FAERS reports marked serious
- 96.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 39.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- respiratory, digestive
- Drugs matched to FDA substances
- isotonic
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
- Durability of Hypertonic Saline for Enhancing Mucociliary Clearance in Cystic Fibrosis NCT01094704 · started 2009 · scored riskier than 59% of active trials completed
- The Effect of Hypertonic Saline on the Lung Clearance Index in Patients With Cystic Fibrosis NCT00635141 · started 2008 · scored riskier than 6% of active trials completed
- A Study of Lung Clearance After Hypertonic Saline Delivery Using the tPAD Device NCT02141191 · started 2014 · scored riskier than 7% of active trials completed
- Effect of Lucinactant on Mucus Clearance in Cystic Fibrosis Lung Disease NCT00934362 · started 2008 · scored riskier than 16% of active trials completed
- Repeatability and Response Study of Absorptive Clearance Scans NCT01887197 · started 2013 · scored riskier than 35% 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.