Immune Response in Hypersensitivity Pneumonitis

NCT03873649 | Completed

• 1 other identifier: 201805937
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Hypersensitivity pneumonitis (HP) is an inflammatory lung disease that is caused by exposure of susceptible individuals to organic materials in the environment. It is also known by various names depending on the exposure and some of these names include farmer's lung, pigeon breeder's lung, hot tub lung to name a few. HP can cause lung scarring that impairs breathing and oxygenation. Early detection and avoidance of triggers can stop and reverse the disease but a significant number of patients continue to have active disease requiring treatment in spite of avoiding the trigger. The current choice of therapies is based on clinical experience and not on rigorous clinical trials. Not fully understanding the type of inflammation that is seen in HP and the cells involved in this inflammatory response limits health care providers' ability to choose drugs to study in HP that can stop the inflammation and limit scar formation. The goal of the investigators' study is to better understand the type of cells that are involved in the inflammatory response in the lungs of HP patients and what drives these cells to be active. By better understanding the type of cells and what drives them, health care providers can begin to choose and study drugs that can limit the inflammation and subsequent scarring. The investigators' will recruit HP patients and with their consent perform a scope of the lungs (bronchoscopy) with a limited lung wash to get the inflamed cells out of the lungs to further study them in the lab. The investigators' study will provide us with preliminary results to guide us in performing a more detailed study in the future to better understand the disease.

Conditions

Hypersensitivity Pneumonitis

Outcome Measures

Primary Outcomes (1)

• T-cell subtypes

  T-cell subtypes will be determined by flow cytometry.

  outcomes will be assessed after recruitment is complete in 2 years.

Study Arms (2)

Patients with subacute or chronic hypersensitivity pneumonitis

Procedures that each subject will undergo include: 1. Chest CT scan to determine extent of disease. 2. Pulmonary function testing to determine severity of disease. 3. Bronchoscopy with lavage. 4. Venipuncture.

Other: Bronchoscopy with lavage

Healthy Controls

Inclusion: 1. Adult between the ages of 18 and 80 years old. 2. Non-smoker or previous smoker quit \>6months ago. 3. Able to understand the consent process and procedures involved in the study. Exclusion: 1. Unable to understand the consent process or procedures involved in the study. 2. Pregnancy. 3. Suspicion of current infection or within the past 3 months. 4. Bleeding disorder or on anti-coagulants other than aspirin. 5. Any co-morbid condition that increases risk of bronchoscopy including but not limited to cardiac disease, uncontrolled hypertension, uncontrolled diabetes and/or morbid obesity.

Other: Bronchoscopy with lavage

Interventions

Bronchoscopy with lavage OTHER

Bronchoscopy will be performed according to standard clinical procedures. Bronchoscopy will be performed under conscious sedation with continuous cardiopulmonary monitoring and the subject's upper airway will be anesthetized with topical lidocaine. The bronchoscope will be passed through the naris or mouth to the upper airway and then into the lower airway. 360cc of sterile saline will be instilled into 2 sub-segments by instilling and aspirating 3 aliquots of 60cc sequentially into each sub-segment. Venipuncture to obtain peripheral blood mononuclear cells (PBMCs) for the proposed assays. Cells collected will be analyzed for various T-cell subsets and gene expression to help determine the type of immune response.

Also known as: blood draw

Healthy Controls; Patients with subacute or chronic hypersensitivity pneumonitis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hypersensitivity Pneumonitis patients with confirmed subacute and chronic HP based on compatible radiological and pathological findings will be eligible for recruitment

You may qualify if:

• Adult between the ages of 18 and 80 years old.
• Non-smoker or previous smoker quit \>6months ago.
• Radiological findings compatible with sub-acute or chronic HP4.
• Histopathological findings compatible with sub-acute or chronic HP4.
• Able to understand the consent process and procedures involved in the study.

You may not qualify if:

• Unable to understand the consent process or procedures involved in the study.
• End-stage lung disease defined as predominantly honeycombing on chest CT and/or FVC\<60% and/or DLCO \<30%.
• Requiring high oxygen needs \>4L.
• Pregnancy.
• Treated with a biological agent within the past 6 months.
• Suspicion of current infection or within the past 3 months.
• Bleeding disorder or on anti-coagulants other than aspirin.
• Any co-morbid condition that increases risk of bronchoscopy including but not limited to cardiac disease, uncontrolled hypertension, uncontrolled diabetes and/or morbid obesity.

Sponsors & Collaborators

• Nabeel Hamzeh: lead
• National Jewish Health: collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Alveolitis, Extrinsic Allergic

Interventions

Bronchoscopy; Therapeutic Irrigation; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures; Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Punctures

Study Officials

• Nabeel Hamzeh, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 13, 2019
• Study Start: November 29, 2018
• Primary Completion: June 30, 2021
• Study Completion: March 30, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)