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Trial record 67 of 201 for:    aspergillosis

Cytokine Profile of Allergic Bronchopulmonary Aspergillosis

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ClinicalTrials.gov Identifier: NCT03643185
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Jin-Fu Xu, Shanghai Pulmonary Hospital, Shanghai, China

Brief Summary:
The main aim of this study is to determine whether the levels of different inflammatory cytokines in the serum and BALF (bronchoalveolar lavage fluid) are relative to the severity and exacerbations of ABPA (allergic bronchopulmonary aspergillosis).

Condition or disease
ABPA

Detailed Description:
The study would record patients' medical data at baseline and follow them up for different period of time. Updated data would be recorded and blood( or BALF) of the patients would be drawn for tests or stored as whole blood or serum at -80℃ when patients visit the hospital. Then the cytokine (A panel set by the manufacturer) of the serum and BALF would be tested . The investigators would then analyze the data and see if any cytokine is relative to the exacerbation or other indicators of the severity of ABPA.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cytokine Profile of Allergic Bronchopulmonary Aspergillosis and Its Relevance to Severity and Exacerbation.
Actual Study Start Date : December 2014
Estimated Primary Completion Date : October 8, 2020
Estimated Study Completion Date : October 8, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis




Primary Outcome Measures :
  1. Cytokines levels [ Time Frame: up to 4 years ]
    The levels of different cytokines in the serum or BALF at the enrollment and during follow up. The relation of different cytokines levels and characteristics of ABPA patients would be analyzed.


Secondary Outcome Measures :
  1. Exacerbation [ Time Frame: 1-4 years ]
    The worsening of the symptoms of patients, or the new infiltrate of lung under CT scan that is relevant to ABPA, or the elevated serum IgE level.

  2. High attenuation mucus (HAM) [ Time Frame: Once ]
    It is defined objectively on a CT scan as having an attenuation value > 70 Hounsfield units, visually denser than the paraspinal skeletal muscle

  3. Eosinophilia [ Time Frame: 1-4 years ]
    Equal to or more than 500/μl

  4. FeNO [ Time Frame: 1-4 years ]
    The fraction of exhaled nitric oxide

  5. Phenotypes of ABPA [ Time Frame: 1 day ]
    Patients would be categorized into three phenotypes: ABPA-S (seropositive), ABPA-CB (central bronchiectasis) and ABPA-ORF (other radiologic findings)


Biospecimen Retention:   Samples With DNA
Bronchoalveolar lavage fluid and serum


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
ABPA patients who were or would be hospitalized in Shanghai Pulmonary Hospital would be recruited. They would receive standard treatment of ABPA and be asked to visit the clinic again one month later after they start taking glucocorticoids. they are also asked to visit the clinic every three month to monitor the change of serum IgE and their condition.
Criteria

Inclusion Criteria:

  • Patients diagnosed as allergic bronchopulmonary aspergillosis (ABPA). The diagnosis criteria of ABPA is as following: clinical diagnosis of asthma, elevated total IgE levels (> 1,000 IU/mL), presence of specific IgE against A fumigatus detected (> 0.35 kUA/L) or type 1 skin reaction to Aspergillus antigen. Other criteria(at least two of three): Presence of serum IgG antibodies (precipitins) against A. fumigatus; Radiographic pulmonary opacities consistent with ABPA(It might be transient consolidation, nodules, finger-in-glove opacities. Or it could be permanent bronchiectasis and pleuropulmonary fibrosis) Patients who sighed consent forms.

Exclusion Criteria:

  • Patients who are unwilling to sign the consent form.
  • Patients under 18 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03643185


Contacts
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Contact: Jin-fu Xu, MD +86 13321922898 jfxucn@163.com

Locations
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China, Shanghai
Shanghai Pulmonary Hospital Recruiting
Shanghai, Shanghai, China, 200433
Contact: Kai-xing Ai, MD    +86-021-65115006      
Contact: , MD         
Sponsors and Collaborators
Shanghai Pulmonary Hospital, Shanghai, China
Investigators
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Principal Investigator: Jin-fu Xu, MD Shanghai Pulmonary Hospital, Shanghai, China

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Responsible Party: Jin-Fu Xu, Director of Respiratory Medicine, Shanghai Pulmonary Hospital, Shanghai, China
ClinicalTrials.gov Identifier: NCT03643185     History of Changes
Other Study ID Numbers: 20180627
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jin-Fu Xu, Shanghai Pulmonary Hospital, Shanghai, China:
cytokine
ABPA

Additional relevant MeSH terms:
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Aspergillosis
Pulmonary Aspergillosis
Aspergillosis, Allergic Bronchopulmonary
Mycoses
Lung Diseases, Fungal
Lung Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Respiratory Tract Infections
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases