At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older, either gender
- ✓Diagnosed with non-cystic fibrosis bronchiectasis (NCFB) by CT or HRCT as predominant condition being treated
- ✓At least 2 pulmonary exacerbations requiring oral/inhaled antibiotics OR 1 exacerbation requiring IV antibiotics in preceding 12 months; no exacerbation between screening visits
- ✓Documented history of P. aeruginosa infection
- ✕Bronchiectasis due to cystic fibrosis (CF)
- ✕History of hypogammaglobulinemia requiring immunoglobulin replacement (unless fully replaced and deemed immuno-competent)
- ✕Myasthenia gravis or porphyria
- ✕Severe cardiovascular disease including uncontrolled hypertension, ischemic heart disease, or cardiac arrhythmia
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Double-blind, Placebo-controlled, Clinical Trial on Efficacy and Safety of 12-months Therapy With Inhaled Colistimethate Sodium in the Treatment of Subjects With Non-cystic Fibrosis Bronchiectasis Chronically Infected With P. Aeruginosa
In Brief
A Phase 3 clinical trial evaluating CMS and Placebo for Non Cystic Fibrosis Bronchiectasis. Completed, enrolled 377 participants across 85 sites in 12 countries.
Detailed Summary
The objective of the trial was to investigate the effect of the use of inhaled CMS, administered b.i.d. via a specific nebuliser for 12 months, compared to placebo in subjects with NCFB chronically infected with P. aeruginosa on the annualised frequency of pulmonary exacerbations.
Study Details
Timeline
Interventions
1 MIU equivalent to 80 mg colistimethate sodium diluted in 1 mL saline solution 0.45%. Investigational Medicinal Product (IMP) glass vials were shrink wrapped in opaque white plastic and provided in boxes of 30 vials (two weeks of b.i.d dosing). The 1 MIU/mL CMS/0.45% saline solution was transferred from the glass vial into a specific nebuliser system fitted with a 0.3 mL medication chamber, for administration by inhalation. This delivered a nominal dose of 0.3 MIU/24 mg CMS (\~10 mg CBA) from the device. The first dose of the IMP was administered at the site under the supervision of the site staff and subjects were instructed how to prepare and self-administer the IMP at home via a specific nebuliser system, b.i.d (morning and evening) over a period of 12 months. At least 10 minutes (min) before each administration, an inhaled short-acting bronchodilator (e.g., salbutamol /albuterol), supplied by the Sponsor, could be taken to improve tolerability.
1 ml saline solution 0.45%. the placebo was made up of identical empty glass vials to which the same saline diluent was added in exactly the same way as the reconstitution of the active treatment by injecting the diluent through the rubber stopper. The glass vials were shrink wrapped with opaque white plastic to maintain the blind.