Trial · NCT03093974
Efficacy and Safety of Inhaled CMS in Bronchiectasis Subjects With Chronic P. Aeruginosa Infection. (PROMIS-I)
NCT03093974, Phase 3, Completed, Zambon SpA; results first posted 2023-11-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Inhaled CMS in Bronchiectasis Subjects With Chronic P. Aeruginosa Infection. (PROMIS-I). Trials, record NCT03093974. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03093974
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Inhaled CMS in Bronchiectasis Subjects With Chronic P. Aeruginosa Infection. (PROMIS-I)
- NCT number
- NCT03093974
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 377 participants, actual
- Lead sponsor
- Zambon SpA
- Conditions
- Non Cystic Fibrosis Bronchiectasis
- Interventions
- CMS, Placebo
- First posted
- 2017-03-28
- Last updated
- 2023-11-15
- Other registries' IDs
- eudract:2015-002743-33
- Results first posted
- 2023-11-15
Source ClinicalTrials.gov
Registered outcomes1
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; * 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). AND in the opinion of the Investigator, the subject required and started treatment with systemic antibiotics. |
Source ClinicalTrials.gov
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 ITT (mITT) Population will comprise all subjects who provided informed consent, were randomised and received at least 1 dose or partial dose of the IMP. | number of Pulmonary Exacerbations | LEAST_SQUARES_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) | 0.580 | 95% Confidence Interval NA to NA | number of Pulmonary Exacerbations | |
| Mean Annual Non-cystic Fibrosis Bronchiectasis (NCFB) Pulmonary Exacerbation Rate | Placebo | 0.948 | 95% Confidence Interval NA to NA | number of Pulmonary Exacerbations |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CMS (Colistimethate Sodium) | 177 | |
| Overall Study | STARTED | Placebo | 200 | |
| Overall Study | Modified Intention to Treat Population - (mITT) | CMS (Colistimethate Sodium) | 176 | |
| Overall Study | Modified Intention to Treat Population - (mITT) | Placebo | 197 | |
| Overall Study | Safety Population (SAF) | CMS (Colistimethate Sodium) | 176 | |
| Overall Study | Safety Population (SAF) | Placebo | 197 | |
| Overall Study | Per -Protocol Population (PP) | CMS (Colistimethate Sodium) | 117 | |
| Overall Study | Per -Protocol Population (PP) | Placebo | 122 | |
| Overall Study | COMPLETED | CMS (Colistimethate Sodium) | 123 | |
| Overall Study | COMPLETED | Placebo | 129 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events112
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 | Infective exacerbation of bronchiectasis | Infections and infestations | CMS (Colistimethate Sodium) (SAF) | 67 | 176 | 110 |
| other | Infective exacerbation of bronchiectasis | Infections and infestations | Placebo (SAF) | 110 | 197 | 196 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | CMS (Colistimethate Sodium) (SAF) | 21 | 176 | 24 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Placebo (SAF) | 19 | 197 | 19 |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | CMS (Colistimethate Sodium) (SAF) | 22 | 176 | 34 |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Placebo (SAF) | 16 | 197 | 19 |
| other | Haemoptysis | Respiratory, thoracic and mediastinal disorders | CMS (Colistimethate Sodium) (SAF) | 9 | 176 | 19 |
| other | Haemoptysis | Respiratory, thoracic and mediastinal disorders | Placebo (SAF) | 19 | 197 | 33 |
| other | Sputum increased | Respiratory, thoracic and mediastinal disorders | CMS (Colistimethate Sodium) (SAF) | 13 | 176 | 13 |
| other | Sputum increased | Respiratory, thoracic and mediastinal disorders | Placebo (SAF) | 7 | 197 | 9 |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CMS (Colistimethate Sodium) (SAF) | 1 | 176 |
| Total, all-cause mortality | Placebo (SAF) | 1 | 197 |
| Total, other adverse events | CMS (Colistimethate Sodium) (SAF) | 142 | 176 |
| Total, other adverse events | Placebo (SAF) | 159 | 197 |
| Total, serious adverse events | CMS (Colistimethate Sodium) (SAF) | 31 | 176 |
| Total, serious adverse events | Placebo (SAF) | 46 | 197 |
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.
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/NCT03093974
GET https://conductscience.org/api/trials/v1/NCT03093974/events?page=2