Efficacy and Safety of Inhaled CMS in Bronchiectasis Subjects With Chronic P. Aeruginosa Infectio… (NCT03093974) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Inhaled CMS in Bronchiectasis Subjects With Chronic P. Aeruginosa Infection. (PROMIS-I)
Australia377 participantsStarted 2017-06-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. are able and willing to give informed consent, following a detailed explanation of participation in the protocol and signed consent obtained;
✓. aged 18 years or older of either gender;
✓. diagnosed with NCFB by computerised tomography (CT) or high resolution CT (HRCT) as recorded in the subject's notes and this is their predominant condition being treated;
✓. had at least 2 NCFB pulmonary exacerbations requiring oral or inhaled antibiotics or 1 NCFB pulmonary exacerbation requiring intravenous antibiotics in the 12 months preceding the Screening Visit (Visit 1) and had no NCFB pulmonary exacerbation with or without treatment during the period between Visit 1 and Visit 2;
✓. have a documented history of P. aeruginosa infection ;
✓. are clinically stable and have not required a change in pulmonary treatment for at least 30 days before the Screening Visit (Visit 1);
✓. have pre-bronchodilator FEV1 ≥25% of predicted;
✓. had a positive sputum culture for P. aeruginosa from an adequate sample taken at the Screening Visit (Visit 1) or during the screening period.
Exclusion criteria
✕. known bronchiectasis as a consequence of cystic fibrosis (CF);
✕. known history of hypogammaglobulinaemia requiring treatment with immunoglobulin, unless fully replaced and considered immuno-competent by the Investigator;
What they're measuring
1
Mean Annual Non-cystic Fibrosis Bronchiectasis (NCFB) Pulmonary Exacerbation Rate
✕. severe cardiovascular disease such as severe uncontrolled hypertension, ischaemic heart disease or cardiac arrhythmia and any other conditions that would confound the evaluation of safety, in the opinion of the Investigator;
✕. had major surgery in the 3 months prior to Screening Visit (Visit 1) or planned inpatient major surgery during the study period;
✕. receiving treatment for allergic bronchopulmonary aspergillosis (ABPA);
✕. had massive haemoptysis (greater than or equal to 300 mL or requiring blood transfusion) in the preceding 4 weeks before Screening Visit (Visit 1) or between Visit 1 and Visit 2;
✕. respiratory failure that would compromise patient safety or confound the evaluation of safety or efficacy of the study in the opinion of the Investigator;