TerminatedPhase 3

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

Stopped: The study was brought to an early close in March 2022 due to major ongoing recruitment issues primarily related to the COVID-19 pandemic and concerns regarding the continued randomization and exposure of subjects to placebo in the study.

United States287 participantsStarted 2018-01-29

Plain-language 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.

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 partecipation 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 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

What they're measuring

Mean Annual Non-cystic Fibrosis Bronchiectasis (NCFB) Pulmonary Exacerbation Rate

Timeframe: 12 months

Trial details

NCT IDNCT03460704

SponsorZambon SpA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-03-15

Results submitted2023-12-11

View on ClinicalTrials.gov More Non Cystic Fibrosis Bronchiectasis trials