Phase
Condition
Idiopathic Pulmonary Fibrosis
Cystic Fibrosis
Pulmonary Fibrosis
Treatment
LTI-03
Placebo
Clinical Study ID
Ages > 40 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female subject of age 40 years or older.
Willing and able to provide written informed consent.
Diagnosis of IPF within 3 years of Screening as confirmed by HRCT of chest or lungbiopsy as defined by ATS/ERS/JRS/ALAT guideline.
Forced vital capacity (FVC) percent predicted ≥ 40%.
Diffusion capacity of the lungs for carbon monoxide (DLCO) percent predicted ≥ 30and ≤ 80.
Forced expiratory volume 1 (FEV1)/FVC ≥ 0.7.
Exclusion
Exclusion Criteria:
Interstitial lung disease other than IPF.
Evidence of significant obstructive lung disease.
Current diagnosis of asthma.
Treatment with an approved or investigational antifibrotic therapy for IPF within 2months of the Baseline bronchoscopy.
Use of N-acetyl cysteine or other supplements within 7 days prior to dosing andthroughout the Treatment Period.
Inability to use study inhaler device appropriately.
Pulmonary exacerbation within 6 months prior to Screening.
Febrile illness within 7 days prior to dosing.
Participation in a clinical study or treatment with an investigational drug ordevice within 30 days of the Screening Visit (or 5 half-lives of the investigationalagent, whichever is longer).
History or evidence at screening of significant renal impairment with eGFR < 30mL/min (region specific).
History or evidence at screening of significant hepatic impairment with bilirubin > 3 mg/dL (> 51.3 µmol/L) and albumin < 2.8 g/dL (<28 g/L) and PT prolongation > 6 secor INR > 2.3 (region specific).
Serious or active medical or psychiatric condition which, in the opinion of theInvestigator, may interfere with treatment, assessment, or compliance with theprotocol.
Vaccination within 2 weeks of start of dosing (Day 1) and throughout the TreatmentPeriod.
Subject has severe progressive or uncontrolled, clinically significant disease thatin the judgment of the investigator or designee renders the subject unsuitable forthe study.
Positive urine pregnancy test in female subjects of childbearing potential asdefined below.
Female subjects who are lactating.
Females of childbearing potential (FOCBP) and men with partners of childbearingpotential who do not agree to use an acceptable form of contraception for theduration of study treatment and for at least 90 days after the last dose of studydrug. Male subjects who do not agree to refrain from donating sperm during this sameperiod.
Study Design
Study Description
Connect with a study center
Agaplesion Evangelisches Krankenhaus Mittelhessen
Gießen,
GermanySite Not Available
University of Edinburgh
Edinburgh,
United KingdomSite Not Available
Royal Brompton Hospital
London, SW3 6HP
United KingdomSite Not Available
Study Site
London, SW3 6HP
United KingdomActive - Recruiting
Royal Victoria Infirmary
Newcastle,
United KingdomSite Not Available
University of Alabama
Birmingham, Alabama 35294
United StatesSite Not Available
Cedars Sinai Medical Center
Los Angeles, California 90048
United StatesSite Not Available
University of Southern California
Los Angeles, California 90033
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.