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NCT03460704 · ClinicalTrials.gov registry record · Phase 3
Trial in Non-cystic Fibrosis Bronchiectasis Patients With Chronic Lung Infections Treated With Colistimethate Sodium.
A Phase 3 study, sponsored by Zambon SpA.
- Terminated
- Registry status
- Phase 3
- Development phase
- 287
- Enrollment target
NCT03460704: Clinical Trial Phase 3 study, sponsored by Zambon SpA.
NCT03460704 is a Phase 3 study that was terminated before completion, run by Zambon SpA. The registered enrollment target is 287 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03460704, a Phase 3 study, was terminated before completion, sponsored by Zambon SpA.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 287 participants
- Enrollment target
Study Summary
The primary objective of the trial was to investigate the effect of the use of inhaled colistimethate sodium (CMS), administered twice a day (b.i.d.) via a specific nebulizer for 12 months, compared to placebo in subjects with non-cystic fibrosis bronchiectasis (NCFB) chronically infected with P. aeruginosa on the annualised frequency of pulmonary exacerbations.
Primary Outcome
The primary efficacy assessment for an individual subject was the frequency of pulmonary exacerbations (exacerbation rate). A pulmonary exacerbation was defined as the presence concurrently of at least three of the following eight symptoms/signs for at least 24 hours: * increased cough; * increased sputum volume and/or consistency; * increased sputum purulence; * new or increased haemoptysis; * increased wheezing; * increased dyspnoea; * increased fatigue/malaise and * episodes of fever (temper
Interventions
- OTHER Placebo
- DRUG CMS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 287 participants |
| Start Date | 2018-01-29 |
| Est. Completion | 2022-03-15 |
| Phase | Phase 3 |
Why NCT03460704 stopped before completion
NCT03460704 is an interventional study that assigns participants to a tested intervention. The registered 287 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03460704 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03460704 about?
NCT03460704 is a clinical study titled "Trial in Non-cystic Fibrosis Bronchiectasis Patients With Chronic Lung Infections Treated With Colistimethate Sodium.". The primary objective of the trial was to investigate the effect of the use of inhaled colistimethate sodium (CMS), administered twice a day (b.i.d.) via a specific nebulizer for 12 months, compared to placebo in subjects with non-cystic fibrosis bronchiectasis (NCFB) chronically infected with P. ae...
What is the current status of trial NCT03460704?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 287 participants. The study started on 2018-01-29. Estimated completion is 2022-03-15.
What interventions are being tested in trial NCT03460704?
The interventions under investigation include: Placebo (OTHER), CMS (DRUG).
Who is sponsoring clinical trial NCT03460704?
This trial is sponsored by Zambon SpA, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03460704's enrollment target sits among peer trials
287 1182nd of 2000 higher than 819 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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