Clinical Trials

Clinical Trials

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Interstitial Lung Disease

Study Coordinators:
Joan Hamlyn: 502-852-8739 /

 

  • A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Sponsor
Promedior

Purpose
This study is a Phase 2, randomized, double-blind, placebo controlled, pilot study designed to evaluate the efficacy and safety of PRM-151 administered through Week 24 to subjects with IPF.

Study Drug
PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks

Status
Active, NOT recruiting

More information at clinicaltrials.gov (NCT02550873)

 

  • Prospective Outcomes Registry of Subjects With Idiopathic Pulmonary Fibrosis

Purpose
This registry will collect data on the strategies used to achieve a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) and the treatment and management efforts applied throughout study follow-up, clinical outcome events and patient reported outcome data. Blood samples will be collected periodically throughout the study for use in future research efforts.

Study Drug
None

Status
Active, recruiting

More information at clinicaltrials.gov (NCT01915511)

 

  • Pulmonary Fibrosis Foundation Patient Registry (PFFR)

Purpose
The Pulmonary Fibrosis Foundation Patient Registry will collect data on at least 2,000 patients with interstitial lung disease (ILD) at approximately 40 clinical sites in the US. The Registry is targeting enrollment of approximately 60% of the 2,000 ILD participants to have idiopathic pulmonary fibrosis (IPF). The aim of the Registry is to create a cohort of well-characterized patients with interstitial lung disease (ILD) for participation in retrospective and prospective research.

Study Drug
None

Status
Active, recruiting

More information at clinicaltrials.gov (NCT02758808)

 

  • A Phase 2, 24-Week, Randomized, Double-blind, Placebo-controlled, Multicenter Study, Followed by a 28-Week Treatment Extension, to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis

Sponsor
Celgene

Purpose
This is a Phase 2, multicenter, multinational, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, pharmacokinetics (PK), quality of life and exploratory pharmacodynamics (PD) of two treatment doses of CC-90001, 200 mg and 400 mg, compared with placebo, when delivered once daily per os (PO) in subjects with idiopathic pulmonary fibrosis (IPF). This study is designed to assess response to treatment by using measures of lung function, disease progression, fibrosis on radiography, and patient-reported outcomes. It will also assess dose response.

Study Drug
CC-90001

Status
Active, recruiting

More information at clinicaltrials.gov (NCT02550873)


Pulmonary Hypertension

Study Coordinators:
Caitlin Cox: 502-852-1377 /

 

  • A Multicenter, Double-blind, Randomized, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of Oral BPS-314d-MR added-on to Treprostinil, Inhaled (Tyvaso®) in Subjects With Pulmonary Arterial Hypertension

Purpose
This is a multicenter, double-blind, randomized, placebo-controlled Phase 3 study, to assess the efficacy and safety of BPS-314d-MR when added-on to inhaled treprostinil (Tyvaso®)in patients with pulmonary arterial hypertension. Patients new to Tyvaso, will enter a run-in period on inhaled treprostinil until 90 days of experience is achieved to ensure drug tolerability before enrolling in the study. Treatment groups consist of one active and one placebo group. Subjects will be randomly allocated in a 1:1 ratio to one of the two treatment groups.

Study Drug
Beraprost Sodium 314d Modified Release Tablets Available as 15 μg tablets for oral, 1 or 2 tablets four times daily (QID) administration

Status
Active, NOT recruiting

More information at clinicaltrials.gov (NCT01908699)

 

  • A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Subjects With Pulmonary Hypertension Due to Parenchymal Lung Disease

Purpose
This is a multicenter, randomized (1:1 inhaled treprostinil: placebo), double-blinded, placebo-controlled trial to evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE). The study will include about 314 patients at approximately 120 clinical trial centers. The treatment phase of the study will last approximately 16 weeks. Patients who complete all required assessments will also be eligible to enter an open-label, extension study (RIN-PH-202).

Study Drug
Active Inhaled Treprostinil for inhalation solution (0.6 mg/mL) delivered via an ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath. Inhaled four times daily and titrated up to a maximum of 12 breaths four times daily

Status
Active, recruiting

More information at clinicaltrials.gov (NCT02630316)

 

  • An Open-Label Extension Study of Inhaled Treprostinil in Subjects With Pulmonary Hypertension Due to Parenchymal Lung Disease

Purpose
This is a multicenter, open-label trial to evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE). The study will include about 266 patients who completed all required assessments in the RIN-PH-201 study at approximately 100 clinical trial centers. The study will continue Your participation in this study is voluntary and will last until you discontinue from the study or the study ends. The study will continue until each subject reaches the Week 108 visit or until inhaled treprostinil become commercially available for patients with PH associated with ILD including CPFE (whichever is sooner).

Study Drug
Inhaled Treprostinil (6 mcg/breath) administered four times daily. Other name: Tyvaso

Status
Active, enrolling by invitation

More information at clinicaltrials.gov (NCT02633293)

 

  • Uptravi® (SelexiPag): tHe usErs dRug rEgistry

Purpose
This is a US multi-center, prospective, real world, observational drug registry enrolling patients actively treated with Uptravi. Participating patients will be followed prospectively for a maximum of 18 months from the date of enrollment into the registry.

Study Drug
None

Status
Active, recruiting

More information at clinicaltrials.gov (NCT03278002)

 

  • A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) in Heart Failure With Preserved Ejection Fraction (HFpEF)

Purpose
This is a multicenter, randomized (1:1; oral treprostinil to placebo), double-blind, placebo-controlled study in subjects with World Health Organization (WHO) Group 2 pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF). Once randomized, subjects will take the initial dose of study drug at the study site on the day of randomization. Subjects will return to the study site for visits scheduled at Weeks 6, 12, 18, and 24. The treatment phase of the study will last approximately 24 weeks.

Study Drug
Oral Treprostinil sustained-release oral tablets for TID administration. Other Name: Treprostinil diethanolamine

Status
Active, recruiting

More information at clinicaltrials.gov (NCT03037580)

 

  • An Open-label Extension Study of Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) Associated With Heart Failure With Preserved Ejection Fraction (HFpEF) - A Long-term Follow-up to Study TDE-HF-301

Purpose
This is an open-label study to evaluate the safety of continued therapy with oral treprostinil in subjects who have completed Study TDE-HF-301. This study will provide long-term, open-label data regarding the effect of continued long-term oral treprostinil therapy for the treatment of pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF). Subject visits will occur at Baseline, Weeks 6, 12, 18, 24, and every 12 weeks thereafter until either oral treprostinil becomes commercially available to treat PH associated with HFpEF or the study is discontinued by the Sponsor.

Study Drug
Oral Treprostinil sustained-release oral tablets for TID administration. Other Name: Treprostinil diethanolamine

Status
Active, recruiting

More information at clinicaltrials.gov (NCT03043651)

 

  • ADAPT - A Patient Registry of the Real-world Use of Orenitram®

Purpose
This is a prospective, observational, multicenter, patient registry to observe and assess the real-world use and tolerability of Orenitram (treprostinil). Patients who are newly initiated on Orenitram for the treatment of pulmonary arterial hypertension (PAH) or who transition from another prostacyclin therapy will be evaluated for 52 weeks to observe dosing regimens, titration schedules, prostacyclin-related adverse events (AEs), and clinical outcomes of interest.

Study Drug
Oral Treprostinil sustained-release oral tablets for TID administration

Status
Active, recruiting

More information at clinicaltrials.gov (NCT03045029)


Interventional Pulmonology

Study Coordinators:
Caitlin Cox: 502-852-1377 /

 

  • BRAVE 3: Bronchial Sample Collection for a Novel Genomic Test – 3

Purpose
This is a specimen and data collection study that is being done to see if researchers can develop a better test by using genes found in the body to more accurately diagnose the different types of pulmonary fibrosis.

 

Status
Active, recruiting

 

  • The Percepta® Registry: A Prospective Registry to Evaluate Percepta® Bronchial Genomic Classifier Patient Data

Purpose
A bronchial genomic classifier was developed and validated to improve the sensitivity and NPV of bronchoscopy for lung cancer detection. The Percepta® classifier identifies patients at low risk of malignancy who may be considered for radiographic monitoring instead of invasive procedure following inconclusive bronchoscopy. This registry is designed to observe physician adoption, evaluate the impact of Percepta on management decisions, and monitor test safety.

 

Status
Active, recruiting


Chronic Obstructive Pulmonary Disease (COPD)

Study Coordinators:
Caitlin Cox: 502-852-1377 /

 

  • Lung Function Improvement After Bronchoscopic Lung Volume Reduction With Pulmonx Endobronchial Valves Used in Treatment of Emphysema

Sponsor
Pulmonx

Purpose
The purpose of this research is to study an investigational medical device that is designed to produce lung volume reduction in diseased areas of the lungs in patients with severe emphysema.

Study Drug
None

Status
Active, NOT recruiting

More information at clinicaltrials.gov (NCT01796392)

 

  • A Prospective, Multi-Center, Randomized, Controlled, Pivotal Trial to Validate the Safety and Efficacy of the Hemolung® Respiratory Assist System for COPD Patients Experiencing an Acute Exacerbation Requiring Ventilatory Support

Purpose
This study evaluates the safety and efficacy of using the Hemolung RAS to provide low-flow extracorporeal carbon dioxide removal (ECCO2R) as an alternative or adjunct to invasive mechanical ventilation for patients who require respiratory support due to an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). It is hypothesized that the Hemolung RAS can be safely used to avoid or reduce time on invasive mechanical ventilation compared to COPD patients treated with standard-of-care mechanical ventilation alone. Eligible patients will be randomized to receive lung support with either the Hemolung RAS plus standard-of-care mechanical ventilation, or standard-of-care mechanical ventilation alone.

Study Drug
None

Status
Active, recruiting

More information at clinicaltrials.gov (NCT03255057)


Critical Care

Study Coordinators:
Caitlin Cox: 502-852-1377 /

 

  • A Phase IV Open-Label Pharmacokinetic Study of Minocycline for Injection Following a Single Infusion in Critically-Ill Adults (ACUMIN)

Purpose
This is a Phase IV, multi-center open-label pharmacokinetic trial studying the pharmacokinetics and pharmacodynamics of a single dose of Minocin IV. Up to 67 subjects will be enrolled to obtain 50 evaluable, ICU patients who are already receiving antimicrobial therapy for a known or suspected Gram-negative infection. The entire study duration will be approximately 12 months and each subject participation duration will be approximately 2 days depending on whether any follow-up is needed. The study will be conducted at approximately 10 clinical sites. Each subject will receive a single 200 mg dose of Minocin IV infused over approximately 60 minutes. Each subject will have 7 PK samples collected (1 pre-dose, 6 post-dose) at designated time points over a ~48 hour period following the start of the Minocin IV infusion. The primary objectives are: 1) To characterize minocycline PK at the population level in critically-ill adults, with illness known or suspected to be caused by infection with Gram-negative bacteria and 2) To assess patient-level and clinical covariates associated with minocycline pharmacokinetic properties in critically-ill adults, with illness known or suspected to be caused by infection with Gram-negative bacteria.

Study Drug
Minocycline

Status
Active, recruiting

More information at clinicaltrials.gov (NCT03369951)

 

  • A Multicenter, Randomized, Double-blind, Parallel-group, Clinical Study of S-649266 Compared With Meropenem for the Treatment of Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia, or Healthcare-associated Bacterial Pneumonia Caused by Gram-negative Pathogens

Purpose
To compare all-cause mortality at Day 14 in participants receiving S-649266 with participants receiving the comparator, meropenem, in adults with hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), or healthcare-associated bacterial pneumonia (HCABP) caused by Gram-negative pathogens.

Study Drug(s)

  • S-649266 2000 mg intravenously every 8 hours for a period of 7 to14 days (dosage adjustment is necessary based on renal function) Other Name: Cefiderocol
  • Meropenem 2000 mg intravenously every 8 hours for a period of 7 to 14 days (dosage adjustment is necessary based on renal function)
    Other Name: Merrem®
  • Linezolid 600 mg administered intravenously over 30 minutes to 2 hours, every 12 hours.
    Other Name: Zyvox®

Status
Active, recruiting

More information at clinicaltrials.gov (NCT03032380)