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 |
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.
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).
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
37
sites
9500 Euclid Avenue
Cleveland, Ohio 44106
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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1720 2nd Ave S
Birmingham, Alabama 35233
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
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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5801 South Ellis Avenue
Chicago, Illinois 60637
Chicago, Illinois 60637
773.702.1234
Principal Investigator: Pamela McShane
Phone: 773-834-4053
University of Chicago One of the world's premier academic and research institutions, the University of...
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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
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Douglas Hornick
Phone: 319-356-3241
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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1601 Northwest 12th Avenue
Miami, Florida 33136
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
Portland, Oregon 97239
503 494-8311
Principal Investigator: Kevin Winthrop
Phone: 503-494-1384
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Sacramento, California 95814
Principal Investigator: Brian Morrissey
Phone: 916-734-3563
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
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
Principal Investigator: Fred Umeh
Phone: 407-507-2615
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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
Principal Investigator: Rodney Folz
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
Principal Investigator: Charles Daley
Phone: 303-270-2622
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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
Phone: 504-568-3450
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New York, New York 10016
Principal Investigator: Doreen Addrizzo-Harris
Phone: 212-263-7951
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New York, New York 10032
Principal Investigator: Angela DiMango
Phone: 212-342-4167
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1501 Superior Avenue
Newport Beach, California 92663
Newport Beach, California 92663
Principal Investigator: Ryan Klein, MD
Phone: 949-791-8599
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Palm Springs, California 92262
Principal Investigator: Ziad Tannous
Phone: 760-778-7799
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3451 Walnut St
Philadelphia, Pennsylvania 19104
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
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
Principal Investigator: Rabin Loutfi
Phone: 941-917-1669
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300 Pasteur Dr
Stanford, California 94305
Stanford, California 94305
(650) 723-4000
Principal Investigator: Stephen Rouss
Phone: 650-723-7409
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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Tacoma, Washington 98405
Principal Investigator: Stephen Ryan
Phone: 253-403-0389
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Towson, Maryland 21204
Principal Investigator: Linda Barr
Phone: 410-494-1662
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Tyler, Texas 75708
Principal Investigator: David Griffith
Phone: 903-877-8246
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Washington, District of Columbia 20007
Principal Investigator: Anne O'Donnell
Phone: 202-444-0895
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Westminster, Maryland 21157
Principal Investigator: Amit Narula
Phone: 410-848-3858
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Winston-Salem, North Carolina 27103
Principal Investigator: Barry Sigal
Phone: 336-659-8414
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