A Study to Identify and Characterise Bacteria Causing Chronic Cough Among Children in United Kingdom
NCT ID: NCT01292213
Last Updated: 2014-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
19 participants
OBSERVATIONAL
2012-05-31
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Cases
Subjects diagnosed with chronic cough who are undergoing general anaesthesia and bronchoscopy/BAL as part of the diagnostic process for chronic cough.
Cough swab
Samples will be tested to determine and characterise the bacteria that may be associated with chronic cough.
Oropharyngeal swab
Samples will be tested to determine and characterise the bacteria that may be associated with chronic cough.
Nasopharyngeal swabs
Samples will be tested to determine and characterise the bacteria and viruses that may be associated with chronic cough.
Blood sample
Samples will be tested to determine and characterise the immunological markers that may be associated with chronic cough.
Bronchoscopy/ bronchoalveolar lavage samples
Samples will be tested to determine and characterise the bacteria, viruses and immunological markers that may be associated with chronic cough.
Data collection
Questionnaire completion.
Controls
Subjects without respiratory symptoms who are undergoing general anaesthesia for elective surgery or endoscopy of non-respiratory-related conditions.
Cough swab
Samples will be tested to determine and characterise the bacteria that may be associated with chronic cough.
Oropharyngeal swab
Samples will be tested to determine and characterise the bacteria that may be associated with chronic cough.
Nasopharyngeal swabs
Samples will be tested to determine and characterise the bacteria and viruses that may be associated with chronic cough.
Blood sample
Samples will be tested to determine and characterise the immunological markers that may be associated with chronic cough.
Bronchoscopy/ bronchoalveolar lavage samples
Samples will be tested to determine and characterise the bacteria, viruses and immunological markers that may be associated with chronic cough.
Data collection
Questionnaire completion.
Interventions
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Cough swab
Samples will be tested to determine and characterise the bacteria that may be associated with chronic cough.
Oropharyngeal swab
Samples will be tested to determine and characterise the bacteria that may be associated with chronic cough.
Nasopharyngeal swabs
Samples will be tested to determine and characterise the bacteria and viruses that may be associated with chronic cough.
Blood sample
Samples will be tested to determine and characterise the immunological markers that may be associated with chronic cough.
Bronchoscopy/ bronchoalveolar lavage samples
Samples will be tested to determine and characterise the bacteria, viruses and immunological markers that may be associated with chronic cough.
Data collection
Questionnaire completion.
Eligibility Criteria
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Inclusion Criteria
* A male or female child between, and including, six to 72 months of age at the time of enrolment.
* Written informed consent obtained from the parent(s)/ legally acceptable representative of the subject.
* No antibiotic therapy within four weeks prior to the visit.
* No cystic fibrosis or known major immunodeficiency such as agammaglobulinaemia, T cell deficiency or Human Immunodeficiency Virus / Acquired Immune Deficiency Syndrome.
* No documented evidence or suspicion of gastroesophageal reflux disease.
* No evidence of an upper viral respiratory infection four weeks prior to the visit.
In addition, all subjects regarded as 'cases' must satisfy all the following criteria at study entry:
* Persistent cough greater than eight weeks.
* No response to five-day prednisolone treatment.
* Chest X-ray showing no evidence of a lobar pneumonia or gross structural abnormality.
In addition, all subjects regarded as 'controls' must satisfy the following criteria at study entry:
* No respiratory symptoms four weeks prior to the visit.
* No documented evidence or suspicion of lung disease upon physical examination.
Exclusion Criteria
* Use of any investigational or non-registered product within 30 days prior to study procedures, or planned use during the study period.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Child in care.
6 Months
72 Months
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Belfast, , United Kingdom
GSK Investigational Site
Bristol, , United Kingdom
GSK Investigational Site
Sheffield, , United Kingdom
Countries
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Other Identifiers
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112956
Identifier Type: -
Identifier Source: org_study_id
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