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Search Results Within Category "Lung Disease & Asthma"

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13 Study Matches

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects with Idiopathic Pulmonary Fibrosis

A phase 3 clinical trial to investigate the effectiveness and safety of a study drug in subjects in Idiopathic Pulmonary Fibrosis

You will be required to attend 8 in-person visits at the Hershey Medical Center over the span of approximately one year. During the study you will have physical examinations, complete questionnaires, review your medical history and current medications, have vital signs and ECGs taken, have blood tests performed, complete pulmonary function testing, and potentially have a high resolution CT scan done. You will take the inhaled treprostinil or placebo daily at home throughout the study.

Yes
 

Rebecca Bascom
Timothy Sheehan - at tsheehan@pennstatehealth.psu.edu or 717-531-2925
Medicine: Pulmonary, Allergy and Critical Care (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04708782
STUDY00020859
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Inclusion Criteria:
At least 40 years of age
Diagnosed with Idiopathic Pulmonary Fibrosis

Exclusion Criteria:
Taking both Esbriet (pirfenidone) and Ofev (nintedanib)
Female participants who are pregnant or lactating
Receiving more than 10 L/min of oxygen supplementation at rest
Lung Disease & Asthma
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety andEfficacy of DWN12088 in Patients With Idiopathic Pulmonary Fibrosis

A Phase 2 Clinical Trial to assess whether study drug DWN12088 is safe and effective in Patients With Idiopathic Pulmonary Fibrosis

During this study, you will be asked to come to in-person visits at the Hershey Medical Center over a period of 6 months During that time you will visit the study center 8 times and have various tests done including: signing informed consent, providing demographics, having a chest CT scan, reviewing medical history, having a physical exam done, having vital signs and an ECG taken, having bloodwork done, receiving study drug, receiving patient diaries, having study drug administered, performing lung function tests (spirometry, DLCO and 6-minute walk test), and completing questionnaires.

Yes
 

Rebecca Bascom
Maris Pedlow - at mpedlow@pennstatehealth.psu.edu or 717-531-2925
Medicine: Pulmonary, Allergy and Critical Care (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05389215
STUDY00020774
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Inclusion Criteria:
At least 40 years of age
Diagnosed with idiopathic pulmonary fibrosis in the past 5 years
Able to walk 150 meters (492 feet) in 6 minutes

Exclusion Criteria:
Unwilling to refrain from smoking
Lower respiratory tract infections requiring antibiotics in the last 4 weeks
Female participants who are pregnant or nursing
Use of investigational drugs for idiopathic pulmonary fibrosis in the last 4 weeks
Lung Disease & Asthma
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

A 52-week, randomised, double-blind, placebo-controlled, parallel group, multi-centre study of the efficacy and safety of GSK3511294 adjunctive therapy in adult and adolescent participants with severe uncontrolled asthma with an eosinophilicphenotype

Placebo-controlled efficacy and safety study of GSK3511294 in participants with severe asthma with an eosinophilic phenotype

There will be 19 in person visits over the course of 15 months where blood, EKGs, and other assessments will occur. You will receive the study drug every 26 weeks.

Yes
 

Timothy Craig
Hunter Smith - at hsmith16@pennstatehealth.psu.edu or 717-531-4513
Medicine: Pulmonary, Allergy and Critical Care (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04718103
STUDY00017203
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Inclusion Criteria:
18 years of age or older
Have, or a high likelihood of having eosinophilic asthma
Have at least 2 asthma attacks requiring steroids in the past 12 months
Take daily inhaled corticosteroids

Exclusion Criteria:
Women of childbearing potential must be on contraception
Participants who have received mepolizumab (Nucala), reslizumab (Cinqair/Cinqaero), or benralizumab (Fasenra) within the last 12 months
Participants who have received omalizumab (Xolair) or dupilumab (Dupixent) within last 130 days prior
Current smoker or history of smoking
Lung Disease & Asthma
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Translational Studies on Electronic Cigarette-derived Oxidants and their Long-term Cardiopulmonary Effects

This is a pilot study on the impact of switching from cigarettes to Electronic Cigarettes on disease-related clinical symptoms and biomarkers of harm in smokers with preexisting COPD

You will be asked to reduce your cigarette smoking and use study-provided e-cigarettes for 3 months. You will be asked to attend 2 in-person visits at the Hershey Medical Center and participate in 4 telephone visits. Throughout the study you will be asked to complete questionnaires, have heart rate, blood pressure and pulse oximetry taken, electrocardiograms (ECGs), height and weight measured, provide medical history, perform pulmonary function tests, complete a 6-minute walk, have your exhaled carbon monoxide measured, provide urine specimen and have blood drawn.

Yes
 

Rebecca Bascom
Timothy Sheehan - at tsheehan@pennstatehealth.psu.edu or 717-531-2925
Medicine: Pulmonary, Allergy and Critical Care (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05239793
STUDY00015514
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Inclusion Criteria:
Ages 21-74
mild-moderate COPD
current smoker

Exclusion Criteria:
actively changing smoking behavior
current use of other tobacco products
allergic to vegetable glycerin and/or propylene glycol
chronic drug and/or alcohol abuse
Smoking, Vaping, Nicotine and Tobacco, Addiction & Substance Abuse, Lung Disease & Asthma
Approved device(s)
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Hershey, PA ,

A PHASE 2, DOUBLE-BLIND, RANDOMIZED, ACTIVE-CONTROL, PARALLEL GROUP STUDY TO ASSESS THE PHARMACOKINETICS, PHARMACODYNAMICS, IMMUNOGENICITY, AND SAFETY OF INBRX-101 COMPARED TO PLASMA DERIVED ALPHA1-PROTEINASE INHIBITOR (A1PI) AUGMENTATION THERAPY IN ADULTS WITH ALPHA-1 ANTITRYPSIN DEFICIENCY (AATD) EMPHYSEMA

Voluntary research study is to test INBRX-101 as an experimental drug to treat patients with alpha-1 antitrypsin deficiency. The goal of this study is to evaluate the safety and study the therapeutic effects of INBRX-101 in AATD emphysema patients when compared with current approved AATD therapy with A1PI.

You will visit the study site up to a total of 37 times for blood sampling, computed tomography (CT) scan, lung function tests, electrocardiograms (ECGs), study drug administration and questionnaire completion.

Unknown at this time

Yes
 

Timothy Craig
Kara Grim - at kgrim@pennstatehealth.psu.edu or 717-531-4513
Medicine: Pulmonary, Allergy and Critical Care (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05856331
STUDY00022890
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Inclusion Criteria:
Males or females 18-80 years of age and Ability to understand and the willingness to sign a written informed consent document
Confirmed diagnosis of alpha-1 antitrypsin deficiency
Evidence of emphysema related to alpha-1 antitrypsin deficiency
Current non-smoking status
Available to participate for duration of study and willingness to commit to all requirements of the study, including study visits

Exclusion Criteria:
Known selective or severe Immunoglobulin A (IgA) deficiency
On waiting list for lung or liver transplant
Known or suspected diagnosis of type 1 diabetes or diagnosed uncontrolled type 2 diabetes
Active cancers or has a history of cancer within 5 years prior to screening
Females who are pregnant or breastfeeding or females of childbearing potential unwilling to practice highly effective contraception during the study
Infectious Diseases & Immune System, Lung Disease & Asthma, Digestive Systems & Liver Disease
Experimental drug compared to an approved drug
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Hershey, PA ,

A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TTI-101 in Participants with Idiopathic Pulmonary Fibrosis

This is a phase 2 pharmaceutical sponsored clinical trial looking to evaluate the safety, tolerability, and efficacy of experimental drug TTI-101 in patients with Idiopathic Pulmonary Fibrosis (IPF).

Participants will attend 7 visits over 18-20 weeks at the Penn State Hershey Medical Center. Participants will receive study treatment for 12 weeks and the study doctor will continue to monitor you for 4 weeks. The study visits will involve completing some procedures and tests such as taking some blood and urine samples, taking vitals signs, physical exams, electrocardiograms (ECGs), questionnaires, breathing and walking tests, and a high-resolution computed tomography (HRCT) scan.

1050

Yes
 

Rebecca Bascom
Tim Sheehan - at tsheehan@pennstatehealth.psu.edu or 717-531-2925
Medicine: Pulmonary, Allergy and Critical Care (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05671835
STUDY00023129
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Inclusion Criteria:
>/= 40 years of age
Diagnosis of Idiopathic Pulmonary Fibrosis
Able to perform breathing tests

Exclusion Criteria:
Received pirfenidone in last 3 months
Receiving steroids >10mg/day
Other types of respiratory disease
Other uncontrolled, clinically relevant disease
No active cancer
Lung Disease & Asthma
Experimental drug compared to a placebo/”sugar pill”
I'm interested
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Hershey, PA ,

Effects of antibiotic use on fecal microbiome and resistome

This study will investigate the changes in the human fecal microbiomes and resistomes in response to antibiotic treatment.

No
 

Jasna Kovac
Jasna Kovac - at jzk303@psu.edu or 814-699-1680
Food Science (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00011756
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Inclusion Criteria:
over age 18
English speaking/reading
Books a medical appointment for upper respiratory tract infection

Exclusion Criteria:
Patient took antibiotics in the past week
Patient participated in STUDY00012891 previously
Reason for medical visit is not upper respiratory tract infection
Patient is pregnant
Patient has a medical history that includes diagnosis of any intestinal related disease
Infectious Diseases & Immune System, Lung Disease & Asthma
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A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Fazirsiran in the Treatment of Alpha-1 Antitrypsin Deficiency–Associated Liver Disease With METAVIR Stage F2 to F4 Fibrosis

This research study of fazirsiran (FAZ-i-sir-an; also called TAK-999 or the “study drug”) because you have alpha-1 antitrypsin deficiency-associated liver disease (AATD LD) with METAVIR stage F2 to F4 fibrosis (METAVIR is a system used to score the amount of inflammation and fibrosis seen in a liver biopsy).In AATD, abnormal (Z-AAT) proteins build up in liver cells, leading to varying amounts of liver problems. The goal of treatment with fazirsiran is to prevent and improve the build up of these abnormal proteins that cause liver injury and fibrosis

-The total amount of time you may be involved in the study is about 4 ½ years (230 weeks).-Screening Period of up to 70 days.-Treatment Period of 196 weeks or about 4 years. During the study, you will get the study drug or placebo at the study site.-Follow-up Period of 6 months. You will have visits 6, 12, and 24 weeks after your last injection of the study drug or placebo.-You will have lung function tests (PFT and DLCO) to check how your lungs are workingAt every visit during the treatment period you will have:-Your vital signs will be measured, this includes your heart rate, blood pressure, breathing rate, temperature, and amount of oxygen in your blood.-You will have a brief physical exam.-Your weight will be measured.-You will have an ECG.-Collect lab samplesDuring specific study visits during the treatment period the following tests will be performed:-An abdominal ultrasound-FibroScan-CT scansYou will complete questionnaires.

Yes
 

Timothy Craig
Kristina Richwine - at krichwine@pennstatehealth.psu.edu or 717-531-4506
Medicine: Pulmonary, Allergy and Critical Care (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05677971
STUDY00021539
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Inclusion Criteria:
The participant, of any sex, is aged 18 to 75 years, inclusive
The participant must use highly effective contraception
The participant must have suitable vein access for blood sampling
Participant agrees not to smoke at any time during the study.
The participant must have a diagnosis of the PiZZ genotype AATD

Exclusion Criteria:
The participant is receiving long-term around-the-clock oxygen (O2) supplementation or supplemental O2 with continuous positive airway pressure (CPAP), or bi-level positive airway pressure (BiPAP) for acute respiratory failure.
The participant has a recent lower respiratory tract infection, such as pneumonia, within the last 6 months before screening.
The participant is expected to have severe and unavoidable high-level exposure to inhaled pulmonary toxins during the study such as may occur with occupational exposure to mineral dusts or metals.
The participant has a history of malignancy within the last 5 years
The participant has evidence of other forms of chronic liver diseases
Allergies, Lung Disease & Asthma, Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

A Survey to Estimate the Socio-Economic Impact of the Novel Corona Virus (COVID-19) Pandemic

We are experiencing global outbreak of coronavirus (COVID-19) recently. Millions of people are suffering and dying every day, in spite of putting our best efforts. We are doing this survey to understand people’s reaction to this situation. The survey will ask about your knowledge, practices and worries. Your response will help us to understand how to better control these situations. Your feedback is highly important to us, as we need to find out the best way to stop the disease from spreading and killing thousands of lives, and to reduce the stress among the population.

No
 

Pritish Mondal
Pritish Mondal - at pmondal@pennstatehealth.psu.edu or 717-897-0652
Pediatrics: Allergy and Immunology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00015136
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Inclusion Criteria:
General population
Adult

Exclusion Criteria:
Age below 18 years
Mentally impaired
Participants from Europe or European Union (EU)
Infectious Diseases & Immune System, Prevention, Lung Disease & Asthma
I'm interested
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A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of PLN-74809 (bexotegrast) for the treatment of idiopathic pulmonary fibrosis (BEACON)

This is a phase 2b clinical trial looking to see if the drug PLN-74809 (bexotegrast) is effective and safe in patients diagnosed with idiopathic pulmonary fibrosis (IPF).

If you choose to participate in this study and meet all the study entry requirements, you will be randomly assigned (by chance; like the flip of a coin) to receive either bexotegrast or placebo for the whole study. Neither your study doctor nor you will know whether you are receiving bexotegrast or placebo. You will be required to visit the Hershey Medical Center on at least 8 separate occasions over an approximate 58-week period. Procedures that will be performed during your visits include, but are not limited to, physical exams, blood tests, ECGs, completing questionnaires, lung functions tests, and CT scans.

1200

Yes
 

Rebecca Bascom
Timothy Sheehan - at tsheehan@pennstatehealth.psu.edu or 717-531-2925
Medicine: Pulmonary, Allergy and Critical Care (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06097260
STUDY00023219
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Inclusion Criteria:
>/= 40 years of age
IPF diagnosis ≤ 7 years prior to screening
If on Ofev or Esbriet, must be on stable dose for >/= 12 weeks
FVC >/=45% predicted
DLCO >/= 30% predicted and </= 90% predicted

Exclusion Criteria:
Taking medication for pulmonary hypertension
Obstructive lung disease
Current smokers
Active infection
IPF exacerbation within the last 6 months
Lung Disease & Asthma
Experimental drug compared to a placebo/”sugar pill”
I'm interested
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Hershey, PA ,

Recruitment for Nicotine and Tobacco Related Research at Penn State Hershey

The purpose of this project is to screen potential participants for multiple research studies being conducted by tobacco researchers at Penn State Hershey. Since there are multiple IRB approved studies enrolling at Penn State Hershey with similar but not identical inclusion/exclusion criteria, it is more efficient for the researchers and participants to have one phone number to call initially for basic screening. After completing this, the participant can be redirected for more specific screening if they are found to be potentially eligible for one of the studies.

Participants will fill out a 5-minute survey on tobacco use in order to find out which study they may be eligible for.

Depends on study

Yes
 

Jonathan Foulds
Nicolle Krebs - at smokingresearch@pennstatehealth.psu.edu or 844-207-6392
Public Health Sciences (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00002213
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Inclusion Criteria:
Age 21 or older
Current tobacco user

Exclusion Criteria:
Age less than 21
Smoking, Vaping, Nicotine and Tobacco, Addiction & Substance Abuse, Lung Disease & Asthma
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Harrisburg, PA ,
Hershey, PA ,
York, PA ,

A 52-week, randomised, double-blind, double-dummy, parallel group, multi-centre, non-inferiority study assessing exacerbation rate, additional measures of asthma control and safety in adult and adolescent severe asthmatic participants with an eosinophilic phenotype treated with GSK3511294 compared with mepolizumab or benralizumab.

Non-inferiority study of GSK3511294 compared with mepolizumab or benralizumab in participants with severe asthma with an eosinophilic phenotype.

You will receive either study drug or placebo, undergo research-related tests and procedures, and questionnaires. You will need to visit the study center up to 18 times over a period of 15 months. You will have different tests and procedures throughout the study. The aim is to check on your health andsymptoms, check on your response to treatment and any side effects, and assess the study drug.This study will compare the study drug with either mepolizumab or benralizumab, known as the comparator medications. The effects of the drugs, both good and bad, will be compared. Study participants will be divided into 2 groups to receive:Study drug (once every 26 weeks) + placebo (once every 4 or 8 weeks) OR,Mepolizumab (once every 4 weeks) or benralizumab (once every 8 weeks) + placebo (once every 26 weeks).All participants will receive an active treatment. You will be assigned to receive either the study drug or comparator (mepolizumab or benralizumab) you were taking before the study. No participant previouslytaking mepolizumab will be assigned to benralizumab, and no participant previously taking benralizumab will be assigned to mepolizumab.

$183.00

Yes
 

Timothy Craig
Kristina Richwine - at krichwine@pennstatehealth.psu.edu or 717-531-4506
Medicine: Pulmonary, Allergy and Critical Care (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04718389
STUDY00017202
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Inclusion Criteria:
Adults 18 years or older at the time of signing the informed consent.
Have a documented diagnosis of asthma for 2 or more years.
Receiving either mepolizumab or benralizumab for 12 or more months prior to screening.
A well-documented requirement for regular treatment with medium to high dose inhaled corticosteroid in the 12 months prior to Visit 1 with or without maintenance oral corticosteroid.
Current treatment with at least one additional controller medication, besides an inhaled corticosteroids.

Exclusion Criteria:
Concurrent respiratory disease
Eosinophilic diseases
Pregnancy
Current or former smokers with a smoking history of 10 or more years.
Active COVID-19 infection
Lung Disease & Asthma
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Hershey, PA ,

A Randomized, Double-blind, Placebo-controlled, Multinational, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects with Progressive Pulmonary Fibrosis (TETON-PPF)

This is a drug study that will examine if inhaled treprostinil is save and effective in people diagnosed with Progressive Pulmonary Fibrosis.

You will be required to attend 8 in-person visits at the Hershey Medical Center over the span of approximately one year. During the study you will have physical examinations, complete questionnaires, review your medical history and current medications, have vital signs and ECGs taken, have blood tests performed, complete pulmonary function testing, and potentially have a high resolution CT scan done. You will take the inhaled treprostinil or placebo daily at home throughout the study.

600

Yes
 

Rebecca Bascom
Tim Sheehan - at tsheehan@pennstatehealth.psu.edu or 717-531-2925
Medicine: Pulmonary, Allergy and Critical Care (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05943535
STUDY00023883
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Inclusion Criteria:
Diagnosis of Pulmonary Fibrosis
Evidence of progression of pulmonary fibrosis in the last 24 months

Exclusion Criteria:
Diagnosis of Idiopathic Pulmonary Fibrosis (IPF)
Evidence of obstructive pulmonary disease
Concomitant use of both nintedanib and pirfenidone is not permitted
Received any PAH-approved therapy in last 60 days
Receiving >10 L/min of oxygen supplementation
Lung Disease & Asthma
Experimental drug compared to a placebo/”sugar pill”
I'm interested
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Hershey, PA ,