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Pulmonary and Critical Care Clinical Trials

The following searchable list includes all the Division of Pulmonary and Critical Care - Department of Medicine clinical trials currently looking for participants. Please feel free to contact us with inquiries about any of our ongoing research.

Trials

A Registry of Interstitial Lung Disease Patients

The purpose of this registry is to collect clinical information about people with interstitial lung disease (ILD) to help us better understand the causes of ILD and determine if particular types of treatment work better for some causes of ILD than others. The Registry will also be used to determine …
The purpose of this registry is to collect clinical information about people with interstitial lung disease (ILD) to help us better understand the causes of ILD and determine if particular types of treatment work better for some causes of ILD than others. The Registry will also be used to determine who might be eligible for and interested in participating in future studies related to ILD.

Participants agree to allow the collection of information from the medical record for research purposes and agree to allow us to contact them about future studies. Participants may also complete questionnaires during their standard of care visits, participate in an optional frailty study by taking a brief physical ability test at the time of standard of care visits, give optional blood for research, and optionally allow us to contact them about their health on an annual basis.

  • At least 18 years old
  • Diagnosis of interstitial lung disease (ILD)
  • Receives care at Northwestern's Pulmonary Clinic
Dematte DDematte D'Amico, Jane E
  • Map it 675 N. Saint Clair St. Eighteenth Floor, Suite 250
    Chicago, IL
STU00060593
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INtervention Study In OverweiGHT Patients with COPD (INSIGHT COPD)

We are conducting the INSIGHT COPD study because symptoms of chronic obstructive pulmonary disease (COPD) and high body mass index (BMI) overlap. There are many medications for patients with COPD, but there is little mention of weight loss as a possible treatment in current research. We are trying to find …
We are conducting the INSIGHT COPD study because symptoms of chronic obstructive pulmonary disease (COPD) and high body mass index (BMI) overlap. There are many medications for patients with COPD, but there is little mention of weight loss as a possible treatment in current research. We are trying to find out if a lifestyle program that promotes modest weight loss and increased physical activity will improve COPD symptoms for those with a high BMI. We hope that the program will lead to weight loss and better exercise tolerance. We are also looking at the effects on shortness of breath, quality-of-life, and cardiovascular disease risk factors.

1 year, 2 visits.

40 years of age or older with COPD, wants to participate in a healthy lifestyle intervention, body mass index of 25 -44.9
Kalhan, RaviKalhan, Ravi
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02634268 STU00204332
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Pathogenic Wnt-beta catenin target genes in macrophages and fibrosis

The purpose of this study is to better understand the development of scleroderma-related lung fibrosis (ILD). We would like to investigate the role of macrophages and other important cells in the development of ILD. Macrophages are types of white blood cells important in the immune system. In healthy people, …
The purpose of this study is to better understand the development of scleroderma-related lung fibrosis (ILD). We would like to investigate the role of macrophages and other important cells in the development of ILD. Macrophages are types of white blood cells important in the immune system. In healthy people, macrophages produce proteins that activate the immune system to assist in tissue repair. However, there is evidence that in people with scleroderma, the macrophages behave abnormally and contribute to scarring in the lungs.

Patients who participate in this study will:

  • donate fluid collected from their lungs during a bronchoscopy (taken at the time they are already scheduled to have a bronchoscopy or during their scheduled endoscopy)
  • give a blood sample
  • give esophageal biopsies (taken during their scheduled endoscopy)
  • as an option, give skin biopsies

  • At least 18 years old
  • Meet criteria for systemic sclerosis
  • Receive care at Northwestern Medicine in Rheumatology, Pulmonary & Critical Care, and/or Gastroenterology scleroderma clinics
  • Plan to undergo a standard of care bronchoscopy or endoscopy at Northwestern or a research bronchoscopy through a separate Northwestern study
Perlman, Harris RPerlman, Harris R
  • Map it 633 N. St. Clair St.
    Chicago, IL
STU00207083
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MACITEPH

The purpose of this trial is to see if macitentan 75 mg versus placebo is useful and safe for treating patients with chronic thromboembolic pulmonary hypertension (CTEPH). Macitentan 10 mg once-daily is approved in many countries around the world for the treatment of pulmonary arterial hypertension (PAH). Macitentan at …
The purpose of this trial is to see if macitentan 75 mg versus placebo is useful and safe for treating patients with chronic thromboembolic pulmonary hypertension (CTEPH). Macitentan 10 mg once-daily is approved in many countries around the world for the treatment of pulmonary arterial hypertension (PAH). Macitentan at a dose of 75 mg is not approved for use by any Regulatory Authority in any country. This means that macitentan is an investigational drug, since it is not approved for use in patients with CTEPH, and can only be used in a research study such as this one.

Participants will be in this study for up to 3.5 years. Participants who choose to join the open label part of the study will be in the study between 2.5 and 6 years.

Participants will:

  • Randomly assigned to macitentan 75 mg or placebo
  • Return for study visits at least 10 times for the first 7 months and then every 12 weeks until the end of the double-blind period.
  • Receive a phone call at week 5 and week 9.
  • If continuing in the open-label study, return for 7 visits for the first 6 months and then every 6 months until the end of the open-label period.
  • Study visits may include health questionnaires, physical exam, blood draw, EKG, 6 minute walk test, urine pregnancy test.
  • Monitor body weight at least once per week at home until week 12.
  • Wear a device to monitor sleep and activity until week 28.
  • Complete questionnaires at home on a mobile device provide to you during the double-blind period.
  • Optionally undergo a right heart catheterization at week 28.

Participants will be paid a stipend after completion of each study visit.

  • Age 18 to 80 years old
  • Diagnosis of CTEPH with one of the following:
  • Inoperable due to the localization of the obstruction being surgically inaccessible
  • Persistent/recurrent CTEPH after BPA and deemed inoperable
  • Persistent/recurrent CTEPH after PEA (including PEA followed by BPA)
    • 6 minute walk test distance between 100 and 450 meters
    • Receiving riociguat for standard of care, unless it is contraindicated
    • If a female of childbearing potential, must use a highly effective method of contraception until at least 30 days after the last dose of study drug
    • Additional exclusion criteria apply
    Cuttica, Michael JCuttica, Michael J
    • Map it 675 N. Saint Clair St. Eighteenth Floor, Suite 250
      Chicago, IL
    NCT04271475 STU00212942
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    Molecular Biomarkers to Guide Therapy in the Systemic Sclerosis-Associated Interstitial Lung Disease

    The purpose of this study is to better understand the development and progression of scleroderma-related lung fibrosis (SSc-ILD). We would like to find indicators (biomarkers) that can help us predict which patients will develop SSc-ILD and who might benefit from receiving certain treatments. To do this, we …

    The purpose of this study is to better understand the development and progression of scleroderma-related lung fibrosis (SSc-ILD). We would like to find indicators (biomarkers) that can help us predict which patients will develop SSc-ILD and who might benefit from receiving certain treatments. To do this, we will collect and study your clinical and imaging data and samples (blood, lung fluid, and skin) if you agree to participate in this research.

    SSc Patients

    Inclusion Criteria:

    • Age 18 or older
    • Receiving clinical care at Northwestern Medicine
    • Meet 2013 ACR criteria for diagnosis of SSc

    Exclusion Criteria:

    • Unable to provide informed consent
    • Diagnosis of an overlap syndrome (i.e., SLE, RA, etc.) that is considered clinically significant by the investigators
    • Currently pregnant or nursing
    • Contraindication to the bronchoscopy per the pulmonologist

    Healthy Controls

    Inclusion Criteria:

    • Age 18 or older
    • Not diagnosed with a rheumatic autoimmune disease (i.e., lupus (SLE), rheumatoid arthritis (RA), etc.)

    Exclusion Criteria:

    • Unable to provide informed consent
    • Currently pregnant or nursing
    • Current smoker or former smoker (> 10 pack years)
    • Lung disease, uncontrolled congestive heart failure, cancer or history of cancer, HIV, or chronic liver disease
    • Contraindication to the bronchoscopy per the pulmonologist
    Misharin, AlexanderMisharin, Alexander
    • Map it 675 N. Saint Clair St. Eighteenth Floor, Suite 250
      Chicago, IL
    • Map it 675 N. Saint Clair St. Fourteenth Floor, Suite 100
      Chicago, IL
    STU00218939
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