Search / Trial NCT00001759

Assessment of Lung Inflammation in Patients With Atopic Asthma Using Positron Emission Tomography

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Dec 9, 2002

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Trial Information

Current as of February 21, 2024

Completed

Keywords

Allergy Fluorodeoxyglucose Imaging Pet Wegener's Granulomatosis Asthma

Description

Asthma is a chronic inflammatory disease. We propose to study inflammatory changes in the lungs of subjects with atopic asthma of different severity in vivo using positron emission tomography (PET) with 2-deoxy-2-[18F]fluoro-D-glucose (FDG). It has been shown that the uptake of FDG as detected by PET scanning correlates with inflammation in animal models as well as in human disease processes such as sarcoidosis, tuberculosis and abscess formation. In addition, it has been shown that the inflammation associated with allergen challenge in patients with atopic asthma can be visualized using PE...

Gender

All

Eligibility criteria

  • Subjects must be between 18 and 55 years of age.
  • Negative pregnancy test within two days of the scan and willingness to adhere to reliable birth control until the completion of the protocol.
  • Subjects must be able to give informed consent.
  • Subjects in the negative control group must have no history of asthma or other lung disease.
  • Control subjects must have negative prick skin tests to the allergens used.
  • Asthmatic subjects must have asthma as defined in this study.
  • Asthmatic subjects must have positive prick skin tests to one or more allergens used.
  • Subjects must have access to a primary medical care provider outside of the NIH.
  • Subjects must weigh less than 136 kg.
  • No breast feeding.
  • No smoking in the last 3 years, or greater than 6 months of smoking in the past ten years.
  • No antihistamines one week prior to the skin test on the first visit.
  • No history of coronary artery disease.
  • No evidence of lung disease other than asthma; no evidence of autoimmune or inflammatory disease which could affect lung function such as lupus erythematosus (except for the control subjects with Wegener's granulomatosis).
  • No evidence of either acute (e.g., bacterial or viral pneumonia) or chronic (e.g., bronchiectasis) lung infection.
  • No diabetes, or history of glucose intolerance (e.g., gestational diabetes).
  • No allergy to methacholine.
  • No beta-adrenergic blocking medication.
  • Control subjects must not have a history of asthma, atopic rhinitis or atopic dermatitis.
  • Control subjects must not have any response to inhaled methacholine with a fall in FEV1 in excess of 20% to less than or equal to 25 mg/ml.
  • Asthmatic subjects must not have chronic bronchitis or a diagnosis of chronic obstructive lung disease (COPD).

Attachments

readout_NCT00001759_2024-02-21.pdf

4.5 MB

NCT00001759_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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