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

NCT01292213 | Terminated

• 1 other identifier: 112956
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Infections, Respiratory Tract

Keywords

Chronic cough; Haemophilus influenzae

Outcome Measures

Primary Outcomes (1)

• Occurrence of Haemophilus influenzae, in the absence of co-infection with other bacteria, in the lower airways of cases and controls

  12-15 months from study initiation

Secondary Outcomes (20)

• Occurrence of Haemophilus influenzae, regardless of co-infection with other bacteria, in the lower airways of cases and controls

  12-15 months from study initiation

• Occurrence of Streptococcus pneumoniae in the lower airways of cases and controls

  12-15 months from study initiation

• Occurrence of Haemophilus influenzae in cough swabs and nasopharynx/ oropharynx of cases and controls

  12-15 months from study initiation

• Occurrence of Haemophilus influenzae in the lower airways and/or nasopharynx/ oropharynx of cases and controls

  12-15 months from study initiation

• Bacterial load of Haemophilus influenzae in the lower airways and nasopharynx/ oropharynx of cases and controls

  12-15 months from study initiation

Study Arms (2)

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; Procedure: Oropharyngeal swab; Procedure: Nasopharyngeal swabs; Procedure: Blood sample; Procedure: Bronchoscopy/ bronchoalveolar lavage samples; Other: Data collection

Controls

Subjects without respiratory symptoms who are undergoing general anaesthesia for elective surgery or endoscopy of non-respiratory-related conditions.

Procedure: Cough swab; Procedure: Oropharyngeal swab; Procedure: Nasopharyngeal swabs; Procedure: Blood sample; Procedure: Bronchoscopy/ bronchoalveolar lavage samples; Other: Data collection

Interventions

Cough swab PROCEDURE

Samples will be tested to determine and characterise the bacteria that may be associated with chronic cough.

Cases; Controls

Oropharyngeal swab PROCEDURE

Samples will be tested to determine and characterise the bacteria that may be associated with chronic cough.

Cases; Controls

Nasopharyngeal swabs PROCEDURE

Samples will be tested to determine and characterise the bacteria and viruses that may be associated with chronic cough.

Cases; Controls

Blood sample PROCEDURE

Samples will be tested to determine and characterise the immunological markers that may be associated with chronic cough.

Cases; Controls

Bronchoscopy/ bronchoalveolar lavage samples PROCEDURE

Samples will be tested to determine and characterise the bacteria, viruses and immunological markers that may be associated with chronic cough.

Cases; Controls

Data collection OTHER

Questionnaire completion.

Cases; Controls

Eligibility Criteria

• Age: 6 Months - 72 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Belfast, BT12 6BE, United Kingdom

Location

GSK Investigational Site

Bristol, BS2 8AE, United Kingdom

Location

GSK Investigational Site

Sheffield, S10 2TH, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Respiratory Tract Infections; Chronic Cough; Haemophilus Infections

Interventions

Blood Specimen Collection; Bronchoscopy; Data Collection

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Cough; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pasteurellaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Diagnostic Techniques, Respiratory System; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Pulmonary Surgical Procedures; Thoracic Surgical Procedures; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2011
• First Posted: February 9, 2011
• Study Start: May 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: September 8, 2014

Record last verified: 2014-09

Locations

GB (3)