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Lung TransplantNCT00340418

Mechanisms of Lung Allograft Rejection

An observational study of Lung Transplant and Chronic Allograft Rejection, run by National Institute of Environmental Health Sciences (NIEHS) at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will explore the ways in which lung transplants are rejected. A series of experiments will evaluate the differences in airway gene expression. Lung transplantation has become an important option for patients with advanced lung disease. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Lung Transplant, Chronic Allograft Rejection
How many people
120 participants
Where
2 sitesUnited States
Study dates
23 Jun 2005to 13 Apr 2007
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All adult (18 and older) lung transplant recipients who are undergoing bronchoscopy as part of the usual posttransplant care will be eligible.

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Duke University Medical Center

    Durham, North Carolina, 27710

  • NIEHS, Research Triangle Park

    Research Triangle Park, North Carolina, 27709

Other trials in United States

About this study

This study will explore the ways in which lung transplants are rejected. A series of experiments will evaluate the differences in airway gene expression. Lung transplantation has become an important option for patients with advanced lung disease. More than 10,000 patients have received them to date, and about 1,200 transplant operations are performed worldwide each year. Although short-term survival has continued to improve, the 5-year survival rate is less than 50%. Most posttransplant deaths are directly or directly caused by chronic lung rejection, a condition of scarring that worsens lung function. .

Patients ages 18 and older who have received lung transplants, who are undergoing bronchoscopy as part of the usual care after transplant, and who are not pregnant may be eligible for this study.

Read more

Bronchoscopy and other procedures performed during this study are done only by doctors with special training. They will take a total of 30 to 60 minutes. During a bronchoscopy, patients will lie on a flat bed. They will be awake and follow instructions. First they will breathe Xylocaine (lidocaine), an anesthetic mist, for 8 to 10 minutes. That will lessen the discomfort of a small flexible tube called a bronchoscope that will be guided through the back of the patient's mouth or nose and into the breathing tubes. When the flexible tube is placed, patients will not be able to speak. They will receive the medication Versed (midazolam), to make them relaxed and not remember most of the procedure, and fentanyl, to decrease the possibility of feeling pain. These medications will be given through a narrow tube feeding into a small needle placed into a vein in the arm. The risks of the tube placed in the vein include bleeding, swelling, redness, and pain. Side effects from the medications may include stomach upset, heart palpitations (awareness of heartbeat), and changes in blood pressure. Patients will be carefully monitored for heart rate, blood pressure, breathing, and oxygen levels.

During the bronchoscopy, a procedure called bronchoalveolar lavage is done, in which a small amount of germ-free salt water is injected into through the bronchoscope into the lung and immediately suctioned back, thus washing the lining of the airways and checking for infection and rejection of the transplanted lungs. About 1 or 2 tablespoons of fluid will be collected for analysis. Also, an endobronchial brush biopsy may be performed. A small brush removes some of the cells from the surface of the airway. These cells will be sent to a laboratory at Duke University Health system to analyze the signals from the cells that may eventually led to scarring and chronic rejection of the lungs. Then, an endobronchial forceps biopsy is performed, in which one or two small pieces, each about the size of a grain of rice, of the lining of the lung's large airways is removed. A small surgical tool like tweezers is passed into the lung. Risks of biopsies may include bleeding, injury to the lung, or an air leak in the lung.

This study will not have a direct benefit for participants. However, it is hoped that information gathered will enhance researchers' understanding of how lung rejection occurs.

Read the detailed description

Lung transplantation has emerged as a viable therapeutic option in the care of patients with advanced pulmonary parenchymal and pulmonary vascular disease. Currently, over 10,000 patients have received lung transplantation with approximately 1200 transplant operations performed worldwide each year. Short term survival after lung transplantation has continued to improve since the widespread application of this procedure and one-year survival at most centers now approaches 80%. Unfortunately, long-term outcomes after lung transplantation are disappointing with five-year survival below 50%. Most posttransplant deaths are due directly or indirectly to the development of chronic allograft rejection, which affects approximately 50% of all five-year survivors. Acute rejection is the major risk factor for the development of chronic rejection. Chronic lung rejection leads to a condition of irreversible fibrosis and obliteration of the small to medium size bronchioles known as obliterative bronchiolitis (OB). Very little is known about the pathogenic mechanisms that lead to the development of OB. Furthermore, it is unclear why acute rejection leads to the development of chronic rejection in some but not all patients. In order to better understand the mechanisms of OB we propose a series of experiments designed to evaluate differences in airway gene expression in a series of lung transplant recipients with and without acute rejection.

Keywords
Bronchoalveolar Lavage, Acute Rejection, Chronic Rejection, Genetic Polymorphisms, Innate Immunity, Lung Transplantation, Lung Allograft Rejection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2006 (estimated)
  2. Study start23 Jun 2005
  3. Study completion13 Apr 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Enrolment
120 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00340418
Sponsor's protocol ID
999905182
Other IDs
05-E-N182
Status last verified
13 Apr 2007
First submitted
19 Jun 2006
Last updated
2 Jul 2017
Results posted
No

Publications

  • Tazelaar HD, Yousem SA. The pathology of combined heart-lung transplantation: an autopsy study. Hum Pathol. 1988 Dec;19(12):1403-16. doi: 10.1016/s0046-8177(88)80233-8.

    PubMed 3142814

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Transplant and Chronic Allograft Rejection, run by National Institute of Environmental Health Sciences (NIEHS) at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00340418, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.

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