Clinical Trials

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Clinical Trials

Welcome to our Clinical Trial Resources page connecting the ATS community to current, ongoing clinical trials in pulmonary, critical care, and sleep medicine being conducted by participating pharmaceutical and device companies.  The ATS does not endorse any trial listed, however we hope the below trial opportunities will be a valuable resource to clinicians, patients, and researchers in the combined goal of improving and advancing patient care. A complete US Clinical Trial listing can be found at http://clinicaltrials.gov/.

If you would like to receive information about new clinical trials listed on this page, please email us to join the Clinical Trial Listserve.


Companies that are ATS Corporate Members at the Supporter Level or higher can list clinical trials at no charge as part of member benefits. If your company is not a current ATS Corporate Member and you would like to see your company’s trials listed, please contact Vlada Kagan O'Hara.

Trials in Allergic Bronchopulmonary Aspergillosis (ABPA)

Trials in Asthma

Trials in Bronchiectasis

Trials in COPD

Trials in COVID-19

Trials in Eosinophilic Granulomatosis with Polyangiitis (EGPA)

Trials in Hypereosinophilic Syndrome (HES)

Trials in Idiopathic Pulmonary Fibrosis (IPF)

Trials in Influenza

Trials in Interstitial Lung Disease (ILD)

Trials in Lung Infection

Trials in PAH

Trials in Pulmonary Hypertension (PH)

Trials in Pulmonary Fibrosis (PF)

Trials in Sarcoidosis


AERIFY1

AERIFY1

Company:

Sanofi

Clinical Trial Title:

Randomized, double-blind, placebo-controlled, parallel-group Phase 3 study to evaluate the efficacy, safety, and tolerability of SAR440340/REGN3500/itepekimab (anti-IL-33 mAb) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) Study # EFC16750

Clinical Trial Description:

EFC16750 is a clinical research study for former smoker patients with moderate to very severe chronic obstructive pulmonary disease (COPD), to evaluate an injectable investigational study drug. The study will enroll approximately 186 patients with COPD in at approximately 47 study centers throughout the United States.

Eligible Patients:

This clinical research study is for adults aged 40-85 years old who have experienced moderate to severe exacerbations of COPD in the last year.

Contact:

A Clinical Trials Contact What is COPD | AERIFY COPD Clinical Study | Sanofi Studies

Date Posted:

April 11, 2022

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AERIFY2

AERIFY2

Company:

Sanofi

Clinical Trial Title:

Randomized, double-blind, placebo-controlled, parallelgroup Phase 3 study to evaluate the efficacy, safety, and tolerability of SAR440340/REGN3500/itepekimab (anti-IL-33 mAb) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) Study # EFC16819

Clinical Trial Description:

EFC16819 is a clinical research study for former smoker patients with moderate to very severe chronic obstructive pulmonary disease (COPD), to evaluate an injectable investigational study drug. The study will enroll approximately 279 patients with COPD in at approximately 86 study centers throughout the United States and Canada.

Eligible Patients:

This clinical research study is for adults aged 40-85 years old who have experienced moderate to severe exacerbations of COPD in the last year.

Contact:

A Clinical Trials Contact What is COPD | AERIFY COPD Clinical Study | Sanofi Studies

Date Posted:

April 11, 2022

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Elevate

Altavant Sciences

Company:

Altavant Sciences

Clinical Trial Title:

A Study of Rodatristat Ethyl in Patients with Pulmonary Arterial Hypertension (ELEVATE 2)

Clinical Trial Description:

ELEVATE 2 is a Phase 2b clinical research study to evaluate the safety and efficacy of Rodatristat Ethyl for the treatment of adult patients with pulmonary arterial hypertension (PAH). The study is expected to enroll 90 patients at expert centers in the US, Canada and Europe.

Eligible Patients:

This clinical research study is for adults age 18 years and older diagnosed with symptomatic PAH belonging to WHO Group 1 on a stable treatment regimen with one or more approved PAH treatments.

Contacts:

Watiri Kamau-Kelley
watiri@altavant.com

Howard Lazarus, MD
howard.lazarus@altavant.com

Date Posted:

March 2, 2021

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Additional Information


ARISE and ENCORE

ARISE and ENCORE

Company:

Insmed Incorporated

Clinical Trial Titles:

ARISE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Validate Patient-Reported Outcome Instruments in Adult Subjects With Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium Avium Complex (MAC)

ENCORE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of an Amikacin Liposome Inhalation Suspension (ALIS)-Based Regimen in Adult Subjects With Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium Avium Complex (MAC)

Clinical Trial Description:

ARISE and ENCORE are parallel clinical research studies for adults with a recent diagnosis of Mycobacterial avium complex (MAC) lung infection to evaluate an inhaled investigational study drug (amikacin liposome inhalation suspension). Eligible patients will be assigned to one of these two studies that together will enroll approximately 350 individuals with MAC lung infection in at approximately 150 study centers globally.

Eligible Patients:

These clinical research studies are for adults age 18 and older with a current diagnosis of Mycobacterium avium Complex (MAC) lung infection.

Contacts:

Insmed Medical Information
844-4-INSMED
medicalinformation@insmed.com

Date Posted:

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Additional Information #1

Additional Information #2

Date Posted:

June 7, 2021


Aspen

ASPEN

Company:

Insmed Incorporated

Clinical Trial Title:

A Phase 3, Randomized, Double blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects With Non-Cystic Fibrosis Bronchiectasis - The ASPEN Study

Clinical Trial Description:

ASPEN is a clinical research study for adults with a clinical diagnosis of non-cystic fibrosis bronchiectasis (NCFBE) to evaluate an investigational study drug (brensocatib). The study will enroll approximately 1620 individuals with NCFBE in at approximately 480 study centers globally.

Eligible Patients:

This clinical research study is for adults age 18 to 85 with a clinical history consistent with NCFBE that is confirmed by chest computerized tomography scan, and a history of at least 2 pulmonary exacerbations in the prior 12 months.

Contacts:

Insmed Medical Information
844-4-INSMED
medicalinformation@insmed.com

Date Posted:

February 17, 2021

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Additional Information


Atlas

ATLAS

Company:

Sanofi

Clinical Trial Title:

Assessing long- Term Lung function decline with dupilum Ab in a Sthma ( ATLAS)

Clinical Trial Description:

Asthma is a chronic inflammatory disease, characterized by variable and reversible airflow obstruction that may involve lung function decline (LFD) over time. LFD results from structural airway changes that accompany underlying airway inflammation in asthma; patients with severe asthma may experience accelerated LFD.  ATLAS (NCT05097287) is a double-blind, placebo-controlled, parallel group, multicenter, study designed to evaluate the role of dupilumab in preventing or slowing LFD over a period of 3 years versus standard of care therapy.

Eligible Patients:

Adult patients with uncontrolled moderate-to-severe asthma on medium-to-high dose inhaled corticosteroids plus controller(s), pre-BD FEV1 ≤80% of predicted normal, and ≥1 exacerbation(s) in the previous year will be included. Approximately 1828 patients (baseline FeNO ≥35 ppb [FeNO population, N=1278] and baseline FeNO <35 ppb [N=550]) will be randomized (2:1) across 25 countries to receive dupilumab 300 mg or matched placebo in combination with maintenance therapy every 2 weeks for 156 weeks.

Contacts:

Contact-US@sanofi.com

Date Posted:

March 25, 2022

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CARE PAH LOGO

CARE PAH

Company:

Janssen Research & Development, LLC

Clinical Trial Title:

67896062PAH4005 (Care PAH)

Clinical Trial Description:

The purpose of this study is to collect data to describe PAH patients in terms of their clinical characteristics, therapies used, disease progression, and outcomes (eg, death, hospitalization, risk category for predicted mortality risk, and patient-reported outcomes [PROs]) in routine clinical practice.

Eligible Patients:

This clinical research study is for adults age 18 and older with pulmonary arterial hypertension (PAH) who have initiated a new PAH-specific therapy or have been on stable therapy of the investigational medication for at least 3 months.

Contacts:

Email: Participate-In-This-Study@its.jnj.com

Date Posted:

September 19, 2022

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Centerstone

CENTERSTONE

Company:

Genentech, a Member of the Roche Group

Clinical Trial Title:

CENTERSTONE

Clinical Trial Description:

CENTERSTONE is a study to assess the efficacy of a single oral dose of baloxavir marboxil versus placebo to reduce the direct transmission of influenza A or B in households and is taking place at multiple sites around the United States and other countries.

Eligible Patients:

CENTERSTONE is open to otherwise-healthy participants between the ages of 5 and 64 with confirmed influenza infection, who have had influenza symptoms for no more than 48 hours. Participants must also have at least 2 household members who are confirmed influenza-negative and are willing to participate.

Contacts:

For more information or to locate a site near you, please visit  https://www.centerstoneflutrial.com/en-us/

Date Posted:

February 17, 2021

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Verona

ENHANCE 1 Trial

Company:

Verona Pharma

Clinical Trial Title:

ENHANCE 1 clinical trial

Clinical Trial Description:

The ENHANCE 1 ( Ensifentrine as a Novel In HAled Nebulized COPD th Erapy) clinical trial is a clinical research study for adults with moderate to severe chronic obstructive pulmonary disease (COPD), including patients on no maintenance/background therapy or patients on stable maintenance LAMA or LABA therapy. The study will enroll approximately 800 individuals with COPD at approximately 100 study centers throughout the United States, Europe, Russia, and South Korea and will last up to 48 weeks.

Eligible Patients:

This clinical research study is for adults age 40 and older.

Contacts:

A Clinical Trials Contact
Robin Morris | Sr. Director | Verona Pharma
8045 Arco Corporate Drive, Suite 130
Raleigh, NC 27617 
M: (646)565-8944
Email: Robin.Morris@Veronapharma.com

Date Posted:

February 17, 2021

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Verona

ENHANCE 2 Trial

Company:

Verona Pharma

Clinical Trial Title:

ENHANCE 2 clinical trial

Clinical Trial Description:

The ENHANCE 2 ( Ensifentrine as a Novel In HAled Nebulized COPD th Erapy) clinical trial is a clinical research study for adults with moderate to severe chronic obstructive pulmonary disease (COPD), including patients on no maintenance/background therapy or patients on stable maintenance LAMA or LABA therapy. The study will enroll approximately 800 individuals with COPD in at approximately 100 study centers throughout the United States and Europe and will last 24 weeks.

Eligible Patients:

This clinical research study is for adults age 40 and older.

Contacts:

Robin Morris | Sr. Director | Verona Pharma
8045 Arco Corporate Drive, Suite 130
Raleigh, NC 27617 
M: (646)565-8944
Email: Robin.Morris@Veronapharma.com

Date Posted:

February 17, 2021

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Freesia

FREESIA

Company:

Janssen Sciences Ireland Unlimited Company  

Clinical Trial Title:

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Clinical Outcomes, Antiviral Activity, Safety, Tolerability, Pharmacokinetics, and Pharmacokinetics/Pharmacodynamics of JNJ-53718678 in Adult and Adolescent Hematopoietic Stem Cell Transplant Recipients with Respiratory Syncytial Virus Infection of the Upper Respiratory Tract

Clinical Trial Description:

The FREESIA study is a clinical research study to evaluate a study medicine in people who have had a stem cell transplant and have since been diagnosed with respiratory syncytial virus (RSV) of the upper airways. The safety and efficacy of using the study drug in RSV treatment for people with stem cell transplants has not yet been established.

The study will enroll approximately 300 individuals at approximately 100 study centers globally.

Eligible Patients:

Adult and adolescent stem cell transplant recipients aged 13 to 75 years of age, with respiratory syncytial virus infection of the upper respiratory tract and having started experiencing RSV symptoms within 4 days of beginning this study (like runny or stuffy nose, sneezing, cough, sore throat, and/or fever).

Date Posted:

01/17/2020

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ino-pf

iNO-PF

Company:

Bellerophon Therapeutics

Clinical Trial Title:

PULSE-PHPF-001:  A Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study To Assess the Safety and Efficacy of Pulsed, Inhaled Nitric Oxide In Subjects with Pulmonary Hypertension Associated with Pulmonary Fibrosis On Oxygen Therapy

Clinical Trial Description:

iNO-PF is a clinical research study evaluating the efficacy, safety and optimal dose of pulse, inhaled nitric oxide (iNO) in adults with low or intermediate/high probability of pulmonary hypertension associated with pulmonary fibrosis (PH-PF).  The study will enroll approximately 80 individuals currently using oxygen therapy at approximately 40 study centers throughout the United States.  The use of additional approved therapies to treat pulmonary fibrosis is not exclusionary.

Eligible Patients:  

This study will enroll subjects age 18 to 85 diagnosed with pulmonary fibrosis by high resolution CT scan.

Contacts:

Contact: Deena Peace deena.peace@bellerophon.com

Date Posted:

January 16, 2019

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liberty

LIBERTY ABPA AIRED STUDY

Company:

Regeneron Pharmaceuticals, Inc.

Clinical Trial Title:

LIBERTY-ABPA AIRED study

Clinical Trial Description:

The LIBERTY-ABPA AIRED study is a clinical research study to test whether an investigational medication helps to decrease episodes of severe breathing difficulties. The study will also evaluate the safety and tolerability of the investigational medication. The study will enroll approximately 170 patients with ABPA.

Eligible Patients:  

This clinical research study is for adults and adolescents age 12 years and older.

Contacts:

Clinical Trials Administrator
844- 734-6643
clinicaltrials@regeneron.com

Date Posted:

January 19, 2022

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Additional Information


liberty

LIBERTY COPD NOTUS

Company:

Sanofi

Clinical Trial Title:

Liberty Notus: Safety & Efficacy of dupilumab in moderate to severe COPD patients

Clinical Trial Description:

Study EFC15805, also called NOTUS, is a Phase 3 clinical research studies for people aged 40-85 who have moderate to severe chronic obstructive pulmonary disease (COPD) and are currently being treated with standard of care therapy.  The study will evaluate whether the study medication can reduce the rate of moderate to severe acute exacerbations of COPD; improve the way patients feel; improve their level of activity; improve their breathing, which may potentially reduce the need for rescue or reliever medications.

During the study, participants will receive either dupilumab or placebo as an injection once every 2 weeks for a year.  All study-related medical care for their COPD as well as their standard of care COPD medication will be covered by the sponsor, Sanofi, at no cost to the study participant.  Compensation for time and travel may also be available for study participants.

The study is currently enrolling patients at ~150 centers throughout the US and Canada.

Eligible Patients:  

This clinical research study is for adults aged 40-85 with a diagnosis of COPD for at least 1 year prior to enrollment.

Contacts:

Contact-US@sanofi.com

Date Posted:

April 22, 2022

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mahale

MAHALE

Company:

AstraZeneca

Clinical Trial Title:

A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 52-Week, Phase III Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients With Non-Cystic Fibrosis Bronchiectasis (MAHALE).

Clinical Trial Description:

MAHALE is a clinical research study to test the hypothesis that benralizumab, an eosinophil depleting antibody, will reduce exacerbation rates compared with placebo on top of standard-of-care therapy in adult patients with non-cystic fibrosis bronchiectasis with eosinophilic inflammation. The study will enroll approximately 420 patients at approximately 105 study centers in 17 countries. All patients who complete the 52-week double-blind treatment period on investigational product may be eligible to continue into an open-label extension, during which all patients will receive benralizumab.

Eligible Patients:  

This clinical research study is for adults age 18 and older with a diagnosis of non-cystic fibrosis bronchiectasis (NCFB) confirmed by computed tomography and a documented history of ≥ 2 exacerbations within a year of the screening visit. Patients will be excluded if they have pulmonary disease other than bronchiectasis (eg, asthma, chronic obstructive pulmonary disease, cystic fibrosis).

Contacts:

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com

Date Posted:

Febraury 17, 2022

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mandara

MANDARA

Company:

AstraZeneca

Clinical Trial Title:

A Randomized, Double-blind, Active-controlled 52-week Study with an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab compared to Mepolizumab in the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA) in patients receiving Standard of Care Therapy (MANDARA).

Clinical Trial Description:

MANDARA is a Phase III study in patients with relapsing or refractory EGPA on corticosteroid therapy with or without stable immunosuppressive therapy. The study will enroll approximately 120 patients globally. All patients who complete the 52-week double-blind treatment period on investigational product may be eligible to continue into an open-label extension, during which all patients will receive benralizumab.

Eligible Patients:  

The clinical research study is for patients age 18 and above who have documented EGPA diagnosis, based on the history or presence of asthma and eosinophilia, plus documentation of at least 2 additional features of EGPA and a history of relapsing or refractory disease.

Contacts:

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com

Date Posted:

February 17, 2022

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natron

NATRON

Company:

AstraZeneca

Clinical Trial Title:

A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 24-week Phase 3 Study with an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients with Hypereosinophilic Syndrome (HES) (NATRON).

Clinical Trial Description:

Hypereosinophilic Syndrome (HES) is a devastating and potentially fatal disease that can cause damage to multiple organs and systems. Benralizumab is an afucosylated monoclonal IgG1 antibody that selectively targets IL-5Rα. Treatment with Benralizumab have demonstrated reductions in exacerbations, improvements in lung function and symptoms in severe eosinophilic asthmatics. NATRON clinical research study will evaluate the potential benefit of if Benralizumab in the treatment of HES. The study will enroll approximately 120 eligible patients in 12 countries.

Eligible Patients:  

The target patient population is male and female patients 12 years of age and older with symptomatic active HES.

Contacts:

AstraZeneca Clinical Study Information Center
1-877-240-9479               
information.center@astrazeneca.com

Date Posted:

February 17, 2022

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Oberon

OBERON

Company:

AstraZeneca

Clinical Trial Title:

Efficacy and Safety of Tozorakimab (MEDI3506) in Symptomatic Chronic Obstructive Pulmonary Disease with a History of Exacerbations.

Clinical Trial Description:

OBERON is one out of two identical global phase 3 trials to evaluate the efficacy and safety of Tozorakimab (MEDI3506) administered subcutaneously in adult participants with symptomatic COPD with a history of exacerbations of COPD in the previous 12 months. Participants should be receiving optimized treatment with maintenance inhaled triple or dual therapy if triple is not indicated or contraindicated, at a stable dose for at least the last 3 months.

Recruitment is currently ongoing and is planned to continue until June 2024. Approximately 1272 participants will be randomized to receive treatment with Tozorakimab (MEDI3506) or matching placebo for 52 weeks on top of standard of care.

The OBERON study will be conducted at about 275 sites in 20 countries: Argentina, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Finland, Hungary, India, Japan, Mexico, Netherlands, Norway, Portugal, South Korea, Spain, Sweden, Turkey, US and Vietnam.

Eligible Patients:  

This clinical research study is for adults age 40 and older with a diagnosis of COPD for at least one year prior to enrollment.

Contacts:

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com

Date Posted:

March 1, 2022

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Bellerophon

PULSE-PHPF-002

Company:

Bellerophon Therapeutics

Clinical Trial Title:

PULSE-PHPF-002:  An Acute Dose Escalation Clinical Study to Assess the Safety and Efficacy of Pulsed, Inhaled, Nitric Oxide (iNO) in Subjects with Pulmonary Hypertension Associated with Pulmonary Fibrosis or Sarcoidosis on Long Term Oxygen Therapy Followed by an Optional Open-Label Long Term Extension Safety Study

Clinical Trial Description:

PULSE-PHPF-002 is a clinical research study evaluating the efficacy, safety and optimal dose of pulse, inhaled nitric oxide (iNO) in adults with pulmonary hypertension associated with pulmonary fibrosis or sarcoidosis.  The study will enroll approximately 16 individuals currently using oxygen therapy at approximately 8 study centers throughout the United States.  The use of additional approved therapies to treat pulmonary fibrosis/sarcoidosis is not exclusionary.

Eligible Patients:  

This study will enroll subjects age 18 to 85 diagnosed with pulmonary fibrosis or sarcoidosis.

Contacts:

Contact: Valerie Parker valerie.parker@bellerophon.com

Date Posted:

January 16, 2019

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Resolute

RESOLUTE

Company:

AstraZeneca

Clinical Trial Title:

A Multicenter, Randomized, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab 100 mg in Patients with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) with a History of Frequent COPD Exacerbations and Elevated Peripheral Blood Eosinophils (RESOLUTE)

Clinical Trial Description:

RESOLUTE is a study to evaluate the efficacy and safety of a benralizumab in patients with moderate to very severe COPD with a history of frequent COPD exacerbations and elevated peripheral blood eosinophils. Eosinophils are a type of blood cell that helps the body to fight infections and is involved in inflammation, immune and allergic reactions.

Eligible Patients:  

Eligible patients must have a history of ≥2 COPD exacerbations that needed the use of oral or intravenous corticosteroids for at least 3 days and/or hospitalizations in the previous year despite receiving stable triple optimized treatment (ICS/LABA/LAMA) for at least 3 months and dual inhaled treatment, where one of the medications must be an inhaled corticosteroid, for the remainder of the year.

Patients who fulfill those criteria will undergo a run-in period with additional tests to confirm eligibility for the study.

Contacts:

AstraZeneca Clinical Study Information Center

Date Posted:

March 1, 2022

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janssen

SALTO STUDY

Company:

Janssen Research & Development, LLC

Clinical Trial Title:

AC-065A310 (SALTO)

Clinical Trial Description:

The purpose of this study is to evaluate whether the addition of an investigational medication to standard of care treatment delays disease progression in children with Pulmonary Arterial Hypertension (PAH) in comparison to placebo.

Eligible Patients:

This clinical research study is for children ages 2 to <18 years old who have pulmonary arterial hypertension (PAH).

Contacts:

Email: Participate-In-This-Study@its.jnj.com

Date Posted:

September 19, 2022

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Starscape

SPRINTER

Company:

Synairgen Research Ltd.

Clinical Trial Title:

A randomised, double-blind, placebo-controlled, Phase 3 trial to determine the efficacy and safety of inhaled Interferon-β therapy (SNG001) for COVID-19 (SPRINTER)

Clinical Trials.gov Identifier:

NCT04732949

Clinical Trial Description:

SPRINTER is a phase 3 trial to confirm that SNG001 can accelerate the recovery of patients with confirmed Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) who are hospitalized and receiving oxygen.  Safety and other efficacy endpoints will also be assessed.

Patients will be randomized in a 1:1 ratio to receive SNG001 two syringes or placebo two syringes, administered via the Ultra nebulizer, once a day for 14 days. Patients will be followed up for up to 90 days after the first dose of study medication. Study data will be collected from patients daily, as per the study schedule.

Eligible Patients:

This clinical research study is for adult patients with SARS-CoV-2 infection confirmed by a positive virus test and who are hospitalized due to COVID-19 and require oxygen therapy.

Contacts:

Jody Brookes
44 (0) 23 8051 2800
Jody.Brookes@synairgen.com

Sophie Hemmings
44 (0) 23 8051 2800
Sophie.Hemmings@synairgen.com

Date Posted:

November 5, 2021

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Starscape

STARSCAPE

Company:

Genentech

Clinical Trial Title:

STARSCAPE

Clinical Trial Description:

For patients with IPF who may or may not already be taking either pirfenidone or nintedanib, Genentech is running a global multicenter phase 3 clinical trial to evaluate the safety and efficacy of recombinant human pentraxin-2 (rhPTX-2; also known as PRM-151). This phase 3 trial is being initiated based upon the results from the phase 2 trial of rhPTX-2 which demonstrated statistically significant and clinically meaningful outcomes in patients with IPF (Raghu et al, JAMA. 2018;319(22):2299-2307)

Eligible Patients:

This clinical research study is for adults aged 40 to 85, who have a diagnosis of IPF. Participants will be expected to demonstrate an FVC of at least 45% predicted and a minimum 6-minute walk distance of 150m.

Contacts:

please contact Genentech at: 888-662-6728, or visit this link

Date Posted:

February 17, 2021

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Titania

TITANIA

Company:

AstraZeneca

Clinical Trial Title:

TITANIA

Efficacy and Safety of Tozorakimab (MEDI3506) in Symptomatic Chronic Obstructive Pulmonary Disease with a History of Exacerbations.

Clinical Trial Description:

TITANIA is one out of two identical global phase 3 trials conducted to evaluate the efficacy and safety of Tozorakimab (MEDI3506) administered subcutaneously in adult participants with symptomatic COPD with a history of exacerbations of COPD in the previous 12 months. Participants should be receiving optimized treatment with maintenance inhaled triple or dual therapy if triple is not indicated or contraindicated, at a stable dose for at least the last 3 months.

Recruitment is currently ongoing and is planned to continue until June 2024. Approximately 1272 participants will be randomized to receive treatment with Tozorakimab (MEDI3506) or matching placebo for 52 weeks on top of standard of care.

The TITANIA study will be conducted at about 250 sites in 19 countries: Australia, Brazil, Chile, China, Colombia, France, Germany, Greece, Israel, Italy, Peru, Philippines, Poland, Romania, Russia, Taiwan, Thailand, UK and US.

Eligible Patients:  

This clinical research study is for adults age 40 and older with a diagnosis of COPD for at least one year prior to enrolment.

Contacts:

AstraZeneca Clinical Study Information Center

Date Posted:

March 1, 2022

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unisus

UNISUS

Company:

Janssen Research & Development, LLC

Clinical Trial Title:

AC-055-315 (UNISUS)

Clinical Trial Description:

The purpose of this study is to compare the safety and effectiveness of a higher dose of an investigational medication against a lower dose for adults with pulmonary arterial hypertension (PAH).

Eligible Patients:

This clinical research study is for adults age 18 and older.

Contacts:

Email: Participate-In-This-Study@its.jnj.com

Date Posted:

September 19, 2022

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Vestige

VESTIGE

Company:

Sanofi

Clinical Trial Title:

VESTIGE

Clinical Trial Description:

The goal of the phase 4, randomized, double-blind, placebo-controlled VESTIGE study (NCT04400318) is to assess dupilumab's effect on lung function and structural airway changes using functional respiratory
imaging (FRI), a novel technology using high-resolution CT (HRCT) scans to produce 3D visualizations and quantify airway structure and function. This study also assesses key biomarkers of airway inflammation, clinical and patient-reported outcomes (PROs), providing data towards a preliminary understanding of the potential relationships between these parameters.

Eligible Patients:  

VESTIGE will enroll patients aged 18–70 years with uncontrolled, moderate-to-severe asthma, ≥300 blood eosinophils/mL, and FeNO≥ 25 ppb at screening. Study sites will be initiated following approval from institutional review boards per local guidelines; all patients will provide written informed consent. Approximately 153 patients will be randomized (2:1) to receive dupilumab 300 mg or matched placebo every 2 weeks for 24 weeks. All patients will receive standard of care

Contacts:

Contact-US@sanofi.com

Date Posted:

March 25, 2022

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