Phase
Condition
Lung Disease
Cystic Fibrosis
Lung Injury
Treatment
Placebo
INS018_055
Clinical Study ID
Ages > 40 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female patients aged ≥40 years based on the date of the written informedconsent form
Diagnosis of IPF as defined by American Thoracic Society/European RespiratorySociety/Japanese Respiratory Society/Latin American Thoracic Association guidelines
In a stable condition and suitable for study participation based on the results ofmedical history, physical examination, vital signs, 12-lead ECG, and laboratoryevaluation
Meeting all of the following criteria during the screening period:
FVC ≥40% predicted normal
DLCO corrected for Hgb ≥25% and <80% predicted normal
Forced Expiratory Volume in the first second/FVC (FEV1/FVC) ratio >0.7 based onpre-bronchodilator value
Exclusion
Exclusion Criteria:
Acute IPF exacerbation within 4 months prior to Visit 1 and/or Day 1, as determinedby the investigator
Patients who are unwilling to refrain from smoking within 3 months prior toscreening and until the end of the study
Female patients who are pregnant or nursing
Abnormal ECG findings
Study Design
Study Description
Connect with a study center
University of Alabama at Birmingham
Birmingham, Alabama 35294
United StatesSite Not Available
University of Alabama at Birmingham
Birmingham 4049979, Alabama 4829764 35294
United StatesActive - Recruiting
HonorHealth Research Institute
Scottsdale, Arizona 85258
United StatesSite Not Available
HonorHealth Research Institute
Scottsdale 5313457, Arizona 5551752 85258
United StatesActive - Recruiting
Keck School of Medicine of USC
Los Angeles, California 90033
United StatesSite Not Available
Keck School of Medicine of USC
Los Angeles 5368361, California 5332921 90033
United StatesActive - Recruiting
Florida Lung Asthma and Sleep Specialist
Celebration, Florida 34747-1818
United StatesSite Not Available
Central Florida Pulmonary Group, P.A. (CFPG) - Downtown Orlando
Orlando, Florida 32803-5727
United StatesSite Not Available
Florida Lung Asthma and Sleep Specialist
Celebration 4150394, Florida 4155751 34747-1818
United StatesActive - Recruiting
Central Florida Pulmonary Group, P.A. (CFPG) - Downtown Orlando
Orlando 4167147, Florida 4155751 32803-5727
United StatesActive - Recruiting
Southeastern Research Center
Winston-Salem, North Carolina 27103-4007
United StatesSite Not Available
Southeastern Research Center
Winston-Salem 4499612, North Carolina 4482348 27103-4007
United StatesActive - Recruiting
University of Oklahoma Health Sciences Center (OUHSC)
Oklahoma City, Oklahoma 73104-5417
United StatesSite Not Available
University of Oklahoma Health Sciences Center (OUHSC)
Oklahoma City 4544349, Oklahoma 4544379 73104-5417
United StatesActive - Recruiting
Temple University Hospital-Temple Lung Center
Philadelphia, Pennsylvania 19140
United StatesSite Not Available
Temple University Hospital-Temple Lung Center
Philadelphia 4560349, Pennsylvania 6254927 19140
United StatesActive - Recruiting
Bogan Sleep Consultants, LLC
Columbia, South Carolina 29201-2953
United StatesSite Not Available
Bogan Sleep Consultants, LLC
Columbia 4575352, South Carolina 4597040 29201-2953
United StatesActive - Recruiting
Univerity of Texas Southwestern Medical Center
Dallas, Texas 75235-6243
United StatesSite Not Available
University of Texas Southwestern Medical Center
Dallas, Texas 75235-6243
United StatesSite Not Available
Metroplex Pulmonary and Sleep Center
McKinney, Texas 75069-1898
United StatesSite Not Available
Research Centers of America
McKinney, Texas 75071
United StatesActive - Recruiting
University of Texas Southwestern Medical Center
Dallas 4684888, Texas 4736286 75235-6243
United StatesActive - Recruiting
Metroplex Pulmonary and Sleep Center
McKinney 4710178, Texas 4736286 75069-1898
United StatesActive - Recruiting
Research Centers of America
McKinney 4710178, Texas 4736286 75071
United StatesActive - Recruiting
University of Utah, University Hospital
Salt Lake City, Utah 84132
United StatesSite Not Available

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