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
	
									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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									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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									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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								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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									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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