CompletedPhase 2

Assessment of INS1007 in Participants With Non-Cystic Fibrosis Bronchiectasis

United States256 participantsStarted 2017-10-31

Plain-language summary

The purpose of the study is to evaluate if INS1007 can reduce pulmonary exacerbations over a 24-week treatment period in participants with non-cystic fibrosis bronchiectasis.

Who can participate

Age range18 Years – 85 Years

SexALL

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Inclusion criteria

✓. Clinical history consistent with NCFBE (cough, chronic sputum production and/or recurrent respiratory infections)
✓. Are current sputum producers with a history of chronic expectoration and able to provide a sputum sample during Screening
✓. Have at least 2 documented pulmonary exacerbations in the past 12 months before Screening

Exclusion criteria

✕. Have a primary diagnosis of chronic obstructive pulmonary disease (COPD) or asthma
✕. Have bronchiectasis due to cystic fibrosis (CF), hypogammaglobulinemia, common variable immunodeficiency, or alpha1-antitrypsin deficiency
✕. Are current smokers
✕. Are currently being treated for a nontuberculous mycobacterial lung infection, allergic bronchopulmonary aspergillosis, or tuberculosis
✕. Have any acute infections, (including respiratory infections)

What they're measuring

Time to the First Pulmonary Exacerbation Over 24-Week Treatment Period

Timeframe: Baseline (Day 1) to Week 24

Trial details

NCT IDNCT03218917

SponsorInsmed Incorporated

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-12-12

Results submitted2022-12-09

View on ClinicalTrials.gov More Non-Cystic Fibrosis Bronchiectasis trials