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

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Brief Title

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

Official Title

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

Brief Summary

      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 PET scanning with FDG. We hypothesize
      that the degree of FDG-uptake as a measure of inflammation correlates with the severity of
      asthma as determined by pulmonary function tests and clinical signs and symptoms. In
      addition, information about the spatial distribution of the inflammatory changes will be
      obtained. To compare the characteristics of the inflammation in asthma with non-asthmatic
      inflammation of the lung, the images obtained in asthmatic subjects will be compared with
      images from subjects who have inflammatory changes of the lung caused by Wegener's
      granulomatosis. Subjects with atopic asthma and non-atopic control subjects will be selected
      from the community and, if eligible for the study, undergo skin testing against common
      allergens and pulmonary function testing. Subjects with Wegener's granulomatosis will be
      selected from a large group of subjects followed with this disease at NIAID. PET scanning
      with FDG will be used to measure inflammation in the PET scanning facility at the Clinical
      Center of the NIH and the results of the scanning will be correlated with the severity of the
      disease. We expect that for the first time this methodology will permit an objective measure
      of the basic pathogenic process, the allergic inflammation, in patients with atopic asthma.
      Using this methodology it will be possible to study the efficacy of currently available
      therapies for allergic inflammation. In addition, this methodology will provide an extremely
      useful tool for the development of new therapeutic approaches to the treatment of asthma.
    

Detailed 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 PET scanning with FDG. We hypothesize
      that the degree of FDG-uptake as a measure of inflammation correlates with the severity of
      asthma as determined by pulmonary function tests and clinical signs and symptoms. In
      addition, information about the spatial distribution of the inflammatory changes will be
      obtained. To compare the characteristics of the inflammation in asthma with non-asthmatic
      inflammation of the lung, the images obtained in asthmatic subjects will be compared with
      images from subjects who have inflammatory changes of the lung caused by Wegener's
      granulomatosis. Subjects with atopic asthma and non-atopic control subjects will be selected
      from the community and, if eligible for the study, undergo skin testing against common
      allergens and pulmonary function testing. Subjects with Wegener's granulomatosis will be
      selected from a large group of subjects followed with this disease at NIAID. PET scanning
      with FDG will be used to measure inflammation in the PET scanning facility at the Clinical
      Center of the NIH and the results of the scanning will be correlated with the severity of the
      disease. We expect that for the first time this methodology will permit an objective measure
      of the basic pathogenic process, the allergic inflammation, in patients with atopic asthma.
      Using this methodology it will be possible to study the efficacy of currently available
      therapies for allergic inflammation. In addition, this methodology will provide an extremely
      useful tool for the development of new therapeutic approaches to the treatment of asthma.
    


Study Type

Observational




Condition

Asthma



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

95

Start Date

December 1997

Completion Date

January 2001


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).
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00001759

Organization ID

980044

Secondary IDs

98-I-0044


Study Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)


Study Sponsor

, , 


Verification Date

February 2000