Assessment of INS1007 in Subjects With Non-Cystic Fibrosis Bronchiectasis



Status:Recruiting
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 85
Updated:3/31/2019
Start Date:December 1, 2017
End Date:June 2020
Contact:Tomoko Shibata
Email:tomoko.shibata@insmed.com
Phone:+1.908.947.2821

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Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety & Tolerability, and PK of INS1007 Administered Once Daily for 24 Weeks in Subjects With Non-CF Bronchiectasis - The Willow Study

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

Phase 2 randomized, double-blind, placebo-controlled, parallel-group, multicenter,
multi-national study to assess the efficacy, safety and tolerability, and pharmacokinetics
(PK) of INS1007 administered once daily for 24 weeks in subjects with non-cystic fibrosis
bronchiectasis (NCFBE).

Inclusion Criteria:

1. Clinical history consistent with NCFBE (cough, chronic sputum production and/or
recurrent respiratory infections)

2. Are current sputum producers with a history of chronic expectoration and able to
provide a sputum sample during Screening

3. Have at least 2 documented pulmonary exacerbations in the past 12 months before
Screening

Exclusion Criteria:

1. Have a primary diagnosis of chronic obstructive pulmonary disease (COPD) or asthma

2. Have bronchiectasis due to cystic fibrosis (CF), hypogammaglobulinemia, common
variable immunodeficiency, or alpha1-antitrypsin deficiency

3. Are current smokers

4. Are currently being treated for a nontuberculous mycobacterial lung infection,
allergic bronchopulmonary aspergillosis, or tuberculosis

5. Have any acute infections, (including respiratory infections)
We found this trial at
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: George Solomon
Phone: 205-638-5599
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Peadar Noone
Phone: 984-974-2972
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Pamela McShane
Phone: 773-834-4053
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Elliott Dasenbrook
Phone: 216-445-6671
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Jorge Lascano
Phone: 352-273-5870
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Douglas Hornick
Phone: 319-356-3241
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1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
Principal Investigator: Maria Gabriela Tupayachi Ortiz
Phone: 305-243-5545
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Kevin Winthrop
Phone: 503-494-1384
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Sacramento, California 95814
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Phone: 916-734-3563
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
Principal Investigator: Shijing Jia
Phone: 734-232-1386
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Atlanta, Georgia 30342
Principal Investigator: Colin Swenson
Phone: 404-251-1650
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Baltimore, Maryland 21205
Principal Investigator: Mark Jennings
Phone: 410-614-1409
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Celebration, Florida 34747
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Charlotte, North Carolina 28215
Principal Investigator: Carl Smart
Phone: 704-264-1400
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Clearwater, Florida 33765
Principal Investigator: Francis Averill
Phone: 727-210-4606
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Cleveland, Ohio 44012
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Phone: 216-844-2371
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Concord, New South Wales
Principal Investigator: Lucy Morgan
Phone: 61 297676334
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Denver, Colorado 80206
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Phone: 303-270-2622
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Farmington, Connecticut 06030
Principal Investigator: Mark Metersky, MD
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Mesquite, Texas 75149
Principal Investigator: Salma Saiger
Phone: 972-216-5152
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Miami Lakes, Florida 33014
Principal Investigator: Idalia Acosta
Phone: 305-424-7420
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New Orleans, Louisiana 70112
Principal Investigator: Juzar Ali
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New York, New York 10016
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New York, New York 10032
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1501 Superior Avenue
Newport Beach, California 92663
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Palm Springs, California 92262
Principal Investigator: Ziad Tannous
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Peoria, Arizona 85381
Principal Investigator: Robert Orr
Phone: 623-523-6430
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Daniel Dorgan
Phone: 215-662-3115
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Principal Investigator: Wissam Chatila
Phone: 215-707-9527
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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Sarasota, Florida 34239
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Phone: 941-917-1669
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300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
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Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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Washington, District of Columbia 20007
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