Trial · NCT03460704

Trial in Non-cystic Fibrosis Bronchiectasis Patients With Chronic Lung Infections Treated With Colistimethate Sodium.

NCT03460704, Phase 3, Terminated, Zambon SpA; results first posted 2023-12-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Trial in Non-cystic Fibrosis Bronchiectasis Patients With Chronic Lung Infections Treated With Colistimethate Sodium. Trials, record NCT03460704. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03460704

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Trial in Non-cystic Fibrosis Bronchiectasis Patients With Chronic Lung Infections Treated With Colistimethate Sodium.
NCT number: NCT03460704
Status: Terminated
Phases: Phase 3
Enrollment: 287 participants, actual
Lead sponsor: Zambon SpA
Conditions: Non Cystic Fibrosis Bronchiectasis
Interventions: CMS, Placebo
First posted: 2018-03-09
Last updated: 2026-10-15
Other registries' IDs: eudract:2016-004558-13
Results first posted: 2023-12-29

Source ClinicalTrials.gov

Registered outcomes20

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mean Annual Non-cystic Fibrosis Bronchiectasis (NCFB) Pulmonary Exacerbation Rate	12 months	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 (temperature ≥38°C). AND It was clinically determined that the subject required and was prescribed systemic antibiotic therapy. AND The episode of exacerbation lasted for at least 24 hours. The overall episode of exacerbation needs to last at least 24 hours, but individual symptoms/signs can last less than 24 hours (e.g, a temperature)
Secondary	Time to First NCFB Pulmonary Exacerbation	12 months	Time to First NCFB Pulmonary Exacerbation (PE) (days) = start date of first NCFB PE - date of randomization. Subjects who completed or discontinued the trial with no NCFB PE are censored at the date of treatment completion/discontinuation.
Secondary	Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score	Up to Visit 7 (12 months) / EoT	The Saint George's Respiratory Questionnaire (SGRQ) is a validated 50-item symptom questionnaire developed to measure health status and Quality of Life (QoL) in subjects with obstructive airway diseases. The scores range from 0 (best possible health status) to 100 (worst possible health status). The total score is calculated as: (sum of the weights of the positive items of all domains / sum of the weights of all items of all domains)\*100. Change from Baseline was calculated as the SGRQ total score at the visit minus Baseline. Change from baseline in SGRQ total score at Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7 were analysed using a linear mixed model for repeated measures including treatment, visit, treatment-by-visit interaction, use of stable concomitant therapy with oral macrolides and pooled site, i.e. country, as fixed effects and baseline value as covariate. An unstructured covariance matrix was assumed and the Kenward-Roger adjustment was used for the degrees of freedom.
Secondary	P. Aeruginosa Density: Change From Baseline at Visit 3 and at Visit 7	Visit 3 (28 days) and Visit 7 (12 months) / EoT	The P. aeruginosa density as determined by the change in log10 CFU/mL sputum from baseline (Visit 2) to Day 28 (Visit 3) was compared between the treatment groups by an ANCOVA model including treatment, pooled site, i.e. country and use of stable concomitant therapy with oral macrolides as fixed effects and baseline value as covariate. Least square means in each treatment group, least square mean difference between treatments, their 95% CIs and associated p-value were estimated.
Secondary	P. Aeruginosa Density: Change From Baseline	Up to Visit 7 (12 months) / EoT	Summary statistics of the P. aeruginosa density (i.e. quantification, log10 CFU/mL sputum) and absolute change from baseline were provided by treatment group for each trial visit.
Secondary	Mean Annual Severe Non-cystic Fibrosis Bronchiectasis (NCFB) Pulmonary Exacerbation Rate	12 months	A severe pulmonary exacerbation was defined as requiring intravenous antibiotics and/or hospitalisation.
Secondary	Time to First Severe NCFB Pulmonary Exacerbation	12 months	Time to First severe NCFB Pulmonary Exacerbation (PE) (days) = start date of first severe NCFB PE - date of randomization. Subjects who completed or discontinued the trial with no severe NCFB PE are censored at the date of treatment completion/discontinuation. Severe exacerbations are defined as those requiring IV antibiotics and/or hospitalisation.
Secondary	NCFB Pulmonary Exacerbation Free Days	12 months	Annualised number of exacerbation-free days = (follow-up time \[days\] - sum of durations of NCFB pulmonary exacerbations \[days\]) / follow-up time (years). For NCFB pulmonary exacerbations with a resolution date after the treatment completion/discontinuation, the number of days of duration after the treatment completion/discontinuation will be subtracted from the sum of durations of NCFB pulmonary exacerbations. Non-parametric ANCOVA model with a randomisation-based methodology was used. The model included treatment group, country, and use of stable concomitant therapy with oral macrolides as covariates.
Secondary	Days of Work Absence	12 months	Number of Days Work Absence is computed for each subject by summing all days of work absence.
Secondary	Days of Work Absence Per Employment Month	12 months	Number of Days Work Absence per Employment Month = Number of Days of Work Absence / Overall Employment Time (months). Number of Days Work Absence is computed for each subject by summing all days of work absence.

1 to 10 of 20Source ClinicalTrials.gov

See all 20 registered outcomes

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Annual Non-cystic Fibrosis Bronchiectasis (NCFB) Pulmonary Exacerbation Rate	12 months	The modified Intention-To-Treat (mITT) Population is the Full Analysis Set and comprised all subjects who provided informed consent, were randomised and received at least 1 dose or partial dose of the IMP.	Number of Pulmonary Exacerbations	MEAN

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Mean Annual Non-cystic Fibrosis Bronchiectasis (NCFB) Pulmonary Exacerbation Rate	CMS (Colistimethate Sodium)		0.889	95% Confidence Interval 0.722 to 1.093	Number of Pulmonary Exacerbations
Mean Annual Non-cystic Fibrosis Bronchiectasis (NCFB) Pulmonary Exacerbation Rate	Placebo		0.885	95% Confidence Interval 0.710 to 1.103	Number of Pulmonary Exacerbations

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	CMS (Colistimethate Sodium)	152
Overall Study	STARTED	Placebo	135
Overall Study	Modified Intention to Treat Population - (mITT)	CMS (Colistimethate Sodium)	152
Overall Study	Modified Intention to Treat Population - (mITT)	Placebo	135
Overall Study	Safety Population - (SAF)	CMS (Colistimethate Sodium)	152
Overall Study	Safety Population - (SAF)	Placebo	135
Overall Study	Per-Protocol Population - (PP)	CMS (Colistimethate Sodium)	112
Overall Study	Per-Protocol Population - (PP)	Placebo	98
Overall Study	COMPLETED	CMS (Colistimethate Sodium)	94
Overall Study	COMPLETED	Placebo	89

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events130

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Asthma	Respiratory, thoracic and mediastinal disorders	CMS (Colistimethate Sodium) (SAF)	5	152	5
other	Asthma	Respiratory, thoracic and mediastinal disorders	Placebo (SAF)	0	135	0
other	Sputum increased	Respiratory, thoracic and mediastinal disorders	CMS (Colistimethate Sodium) (SAF)	3	152	3
other	Sputum increased	Respiratory, thoracic and mediastinal disorders	Placebo (SAF)	2	135	3
other	Constipation	Gastrointestinal disorders	CMS (Colistimethate Sodium) (SAF)	4	152	5
other	Constipation	Gastrointestinal disorders	Placebo (SAF)	1	135	1
other	Arthralgia	Musculoskeletal and connective tissue disorders	CMS (Colistimethate Sodium) (SAF)	2	152	4
other	Arthralgia	Musculoskeletal and connective tissue disorders	Placebo (SAF)	3	135	4
other	Muscoskeletal chest pain	Musculoskeletal and connective tissue disorders	CMS (Colistimethate Sodium) (SAF)	3	152	3
other	Muscoskeletal chest pain	Musculoskeletal and connective tissue disorders	Placebo (SAF)	2	135	2

1 to 10 of 130Source ClinicalTrials.gov

See all 130 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	CMS (Colistimethate Sodium) (SAF)	3	152
Total, all-cause mortality	Placebo (SAF)	2	135
Total, other adverse events	CMS (Colistimethate Sodium) (SAF)	123	152
Total, other adverse events	Placebo (SAF)	104	135
Total, serious adverse events	CMS (Colistimethate Sodium) (SAF)	27	152
Total, serious adverse events	Placebo (SAF)	17	135

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
CMS (Colistimethate Sodium) (SAF) vs Placebo (SAF): deaths from any cause	Trial comparisons
CMS (Colistimethate Sodium) (SAF) vs Placebo (SAF): serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03460704

GET https://conductscience.org/api/trials/v1/NCT03460704/events?page=2

API reference For AI assistants