Assessment of INS1007 in Participants With Non-Cystic Fibrosis Bronchiectasis

Completed · Phase 2 · Has a placebo group

Conditions studied: Non-Cystic Fibrosis Bronchiectasis

In brief

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.

Key facts

Study ID

NCT03218917

Run by

Insmed Incorporated

People needed

256

Starts

2017-10-31

Expected to finish

2019-12-12

Last updated by the study team

2023-03-27

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Phoenix Medical Group — Peoria, Arizona, United States
• NewportNativeMD — Newport Beach, California, United States
• Palmtree Clinical Research — Palm Springs, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• Stanford University Medical Center — Stanford, California, United States
• National Jewish Heath — Denver, Colorado, United States
• UConn Health Center — Farmington, Connecticut, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Clinical Research Specialists, LLC — Celebration, Florida, United States
• St. Francis Medical Institute — Clearwater, Florida, United States
• University of Florida — Gainesville, Florida, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• San Marcus Research Clinic, Inc. — Miami Lakes, Florida, United States
• Sarasota Memorial Hospital Clinical Research Center — Sarasota, Florida, United States
• The Emory Clinic, Pulmonology — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• University of Iowa — Iowa City, Iowa, United States
• LSU Health Sciences Center — New Orleans, Louisiana, United States
• Johns Hopkins University, Division of Pulmonary and Critical Care Medicine — Baltimore, Maryland, United States
• Pulmonary and Critical Care Associates of Baltimore — Towson, Maryland, United States
• Mid Atlantic Pulmonary & Research Center — Westminster, Maryland, United States
• Michigan Medicine — Ann Arbor, Michigan, United States
• NYU Pulmonary & Critical Care Associates — New York, New York, United States
• Columbia University Medical Center/ New York Presbyterian Hospital — New York, New York, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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