Download ILD and IPF Clinical Trials

IPF Clinical Trials
Currently Enrolling
STUDY COORDINATOR’S INFORMATION
Candace Flaherty: [email protected], Pager
# 37472, 734-936-8301
Cough Study (HUM 104112)
Needed: Patients with ILD and a persistent cough for at least 8 weeks. AF-219 is a P2X3 receptor being studied as potential tx for cough.
Purpose is looking at potential side effects and efficacy when taken BID compared to placebo. Crossover study design, so patient will be on
placebo for 2 weeks, and study drug for 2 weeks.
Inclusion
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Diagnosis of IPF by HRCT or SLB and stable for 4 weeks
Self-reported history of troublesome daily cough weeks (if asked on scale of 1-100, should be >40 self- reported to determine if VAS
is eligible)
Exclusion
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Current smoker
Beginning of treatment with an ACE-inhibitor (which treats high blood pressure) within 4 weeks prior to the Baseline Visit (Day 0) or
during the study
History of opioid use for treatment of cough within 1 week of the Baseline Visit
Body mass index (BMI) <18 kg/m2 or ≥ 40 kg/m2
Recent history of stroke or TIA (within 6 months prior to Screening)
Blood donation within 56 days or plasma donation within 7 days prior to dosing
Any condition possibly affecting drug absorption (e.g., gastrectomy, gastroplasty, any type of bariatric surgery, vagotomy (surgery
treating ulcer disease), or bowel resection)
History of cutaneous adverse drug reaction to sulfonamides or signs and symptoms suggestive of anaphylaxis to sulfonamides
An Exploratory Multicenter Open-label Single Arm Study of the Safety and Tolerability of Pirfendidone in Combination with
Nintedanib in Patients with IPF (HUM 108398)
Needed: Patients with mild to moderate ILD pirfenidone for at least 16 weeks and on stable dose for at least 28 days prior to screening willing
to add nintedanib to treatment course. The expected study length is up to 21 months
Inclusion
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Ages 40-80 inclusive
Diagnosis of IPF by HRCT or SLB
FVC ≥ 50%
DLCO ≥ 30%
Exclusion
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Evidence of active infection
Lung txp anticipated in 12 months after start of screening
Known hypersensitivity to the active substance or any excipient of either pirfenidone or nintedanib
Any planned significant surgical intervention during time of study
QtcF ≥ 500 ms at Screening
Use of strong CYP1A2 inhibitors
History of unstable cardiac or pulmonary disease in 6 months prior to screening; such as MI, CHF, uncontrolled clinically significant
arrhythmias.
Severe hepatic or renal impairment
History or risk of GI tract perforation
Use of any tobacco product in the 12 weeks before the start of Screening
IPF PRO Registry (HUM 87132)
Needed: Patients recently diagnosed (within 3 months from ILD conference date) returning to UM on a regular basis for follow up. Prospective
registry will collect information regarding natural history, questionnaire data and blood samples for repository during scheduled return clinic
visits.
Inclusion
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Ages 40 or greater
New diagnosis of IPF at ILD conference
Exclusion
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Malignancy other than skin cancer with past 5 years
Previously diagnosed at this site with IPF
Currently listed for lung txp
Currently enrolled in randomized clinical trial
WRAP Study Criteria (HUM 81631)
Needed: Patients diagnosed with IPF and evidence of abnormal acid gastro-esophageal reflux by 24-hour pH testing.
Inclusion
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Confirmed IPF
Abnormal GER on 24-hour pH monitoring and esophageal manometry
Be willing to under laparoscopic anti-reflux surgery
Exclusion
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FVC < 50% predicted
FEV1/FVC ratio < 0.65
Resting room air PaO2 < 60mm Hg
Unable to walk 50 meters on 6 minute walk test
Recent acute respiratory illness in last 12 weeks
Listed for lung transplantation at screening
History of esophageal / bariatric / gastric surgery
BMI > 35
Unlikely to obtain pre-authorized approval from a third party payer for laparoscopic anti-reflux surgery and related costs in the opinion
of the investigators
Known severe pulmonary hypertension
History of cancer (other than non-melanoma skin cancer) in the last 3 years