A Study to Identify and Characterise Bacteria Causing Chronic Cough Among Children in United Kingdom

This study has been terminated.
(• Long delay due to challenges with sample analysis at local labs; • Low recruitment of case and control subjects; • Constant staff turn-over in the sites.)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01292213
First received: February 3, 2011
Last updated: September 4, 2014
Last verified: September 2014
  Purpose

The purpose of this study is to investigate the role of Haemophilus influenzae and other bacteria in causing chronic cough, through a direct comparison of chronic cough cases and healthy controls recruited from paediatric respiratory clinics in the United Kingdom.


Condition Intervention
Infections, Respiratory Tract
Procedure: Cough swab
Procedure: Oropharyngeal swab
Procedure: Nasopharyngeal swabs
Procedure: Blood sample
Procedure: Bronchoscopy/ bronchoalveolar lavage samples
Other: Data collection

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Identification and Characterisation of Bacteria Causing Chronic Cough Among Children in the United Kingdom

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of Haemophilus influenzae, in the absence of co-infection with other bacteria, in the lower airways of cases and controls [ Time Frame: 12-15 months from study initiation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of Haemophilus influenzae, regardless of co-infection with other bacteria, in the lower airways of cases and controls [ Time Frame: 12-15 months from study initiation ] [ Designated as safety issue: No ]
  • Occurrence of Streptococcus pneumoniae in the lower airways of cases and controls [ Time Frame: 12-15 months from study initiation ] [ Designated as safety issue: No ]
  • Occurrence of Haemophilus influenzae in cough swabs and nasopharynx/ oropharynx of cases and controls [ Time Frame: 12-15 months from study initiation ] [ Designated as safety issue: No ]
  • Occurrence of Haemophilus influenzae in the lower airways and/or nasopharynx/ oropharynx of cases and controls [ Time Frame: 12-15 months from study initiation ] [ Designated as safety issue: No ]
  • Bacterial load of Haemophilus influenzae in the lower airways and nasopharynx/ oropharynx of cases and controls [ Time Frame: 12-15 months from study initiation ] [ Designated as safety issue: No ]
  • Occurrence of Haemophilus haemolyticus in the lower airways and nasopharynx/ oropharynx of cases and controls [ Time Frame: 12-15 months from study initiation ] [ Designated as safety issue: No ]
  • Antimicrobial resistance of Haemophilus influenzae in lower airways [ Time Frame: 12-15 months from study initiation ] [ Designated as safety issue: No ]
  • Occurrence of viral pathogens in the lower airways and nasopharynx of cases and controls [ Time Frame: 12-15 months from study initiation ] [ Designated as safety issue: No ]
  • Occurrence of Moraxella catarrhalis in the lower airways of cases and controls [ Time Frame: 12-15 months from study initiation ] [ Designated as safety issue: No ]
  • Occurrence of other bacterial pathogens in the lower airways of cases and controls [ Time Frame: 12-15 months from study initiation ] [ Designated as safety issue: No ]
  • Occurrence of Streptococcus pneumoniae in cough swabs and nasopharynx/ oropharynx of cases and controls [ Time Frame: 12-15 months from study initiation ] [ Designated as safety issue: No ]
  • Occurrence of Moraxella catarrhalis in cough swabs and nasopharynx/ oropharynx of cases and controls [ Time Frame: 12-15 months from study initiation ] [ Designated as safety issue: No ]
  • Occurrence of Streptococcus pneumoniae in the lower airways and/or nasopharynx/ oropharynx of cases and controls [ Time Frame: 12-15 months from study initiation ] [ Designated as safety issue: No ]
  • Occurrence of other bacterial pathogens in the lower airways and/or nasopharynx/ oropharynx of cases and controls [ Time Frame: 12-15 months from study initiation ] [ Designated as safety issue: No ]
  • Bacterial load of Streptococcus pneumoniae in the lower airways and nasopharynx/ oropharynx of cases and controls [ Time Frame: 12-15 months from study initiation ] [ Designated as safety issue: No ]
  • Bacterial load of Moraxella catarrhalis in the lower airways and nasopharynx/ oropharynx of cases and controls [ Time Frame: 12-15 months from study initiation ] [ Designated as safety issue: No ]
  • Occurrence of serotypes of Haemophilus influenzae in the lower airways and nasopharynx/ oropharynx of cases and controls [ Time Frame: 12-15 months from study initiation ] [ Designated as safety issue: No ]
  • Occurrence of serotypes of Streptococcus pneumoniae in the lower airways and nasopharynx/ oropharynx of cases and controls [ Time Frame: 12-15 months from study initiation ] [ Designated as safety issue: No ]
  • Antimicrobial resistance of Streptococcus pneumoniae in lower airways [ Time Frame: 12-15 months from study initiation ] [ Designated as safety issue: No ]
  • Antimicrobial resistance of Moraxella catarrhalis in lower airways [ Time Frame: 12-15 months from study initiation ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Cough swab, oropharyngeal swab, nasopharyngeal swabs, blood and bronchoscopy/ bronchoalveolar lavage samples.


Enrollment: 19
Study Start Date: May 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cases
Subjects diagnosed with chronic cough who are undergoing general anaesthesia and bronchoscopy/BAL as part of the diagnostic process for chronic cough.
Procedure: Cough swab
Samples will be tested to determine and characterise the bacteria that may be associated with chronic cough.
Procedure: Oropharyngeal swab
Samples will be tested to determine and characterise the bacteria that may be associated with chronic cough.
Procedure: Nasopharyngeal swabs
Samples will be tested to determine and characterise the bacteria and viruses that may be associated with chronic cough.
Procedure: Blood sample
Samples will be tested to determine and characterise the immunological markers that may be associated with chronic cough.
Procedure: 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.
Other: Data collection
Questionnaire completion.
Controls
Subjects without respiratory symptoms who are undergoing general anaesthesia for elective surgery or endoscopy of non-respiratory-related conditions.
Procedure: Cough swab
Samples will be tested to determine and characterise the bacteria that may be associated with chronic cough.
Procedure: Oropharyngeal swab
Samples will be tested to determine and characterise the bacteria that may be associated with chronic cough.
Procedure: Nasopharyngeal swabs
Samples will be tested to determine and characterise the bacteria and viruses that may be associated with chronic cough.
Procedure: Blood sample
Samples will be tested to determine and characterise the immunological markers that may be associated with chronic cough.
Procedure: 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.
Other: Data collection
Questionnaire completion.

  Eligibility

Ages Eligible for Study:   6 Months to 72 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children aged six to 72 months, residing in the United Kingdom. These children will be classified as cases and controls.

Cases will be children who have had persistent cough for greater than eight weeks and are undergoing general anaesthesia for clinically indicated bronchoscopy/ bronchoalveolar lavage as part of the diagnostic process for chronic cough.

Controls will be children who are undergoing general anaesthesia with endotracheal intubation for elective surgery or endoscopy for non-respiratory-related conditions and had no acute or chronic respiratory symptoms during the four weeks prior to the visit.

Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that parent(s)/ legally acceptable representative can and will comply with the requirements of the protocol.
  • 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:

  • Concurrently participating in another study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01292213

Locations
United Kingdom
GSK Investigational Site
Belfast, United Kingdom, BT12 6BE
GSK Investigational Site
Bristol, United Kingdom, BS2 8AE
GSK Investigational Site
Sheffield, United Kingdom, S10 2TH
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01292213     History of Changes
Other Study ID Numbers: 112956
Study First Received: February 3, 2011
Last Updated: September 4, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
Chronic cough
Haemophilus influenzae

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014