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

GlaxoSmithKline (GSK)

Status

Terminated

Conditions

Infections, Respiratory Tract

Treatments

Procedure: Oropharyngeal swab

Procedure: Bronchoscopy/ bronchoalveolar lavage samples

Procedure: Blood sample

Procedure: Nasopharyngeal swabs

Procedure: Cough swab

Other: Data collection

Study type

Observational

Funder types

Industry

Identifiers

NCT01292213

112956

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

6 to 72 months old

Volunteers

No Healthy Volunteers

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.

Trial design

19 participants in 2 patient groups

Cases

Description:

Subjects diagnosed with chronic cough who are undergoing general anaesthesia and bronchoscopy/BAL as part of the diagnostic process for chronic cough.

Treatment:

Procedure: Bronchoscopy/ bronchoalveolar lavage samples

Procedure: Oropharyngeal swab

Procedure: Blood sample

Other: Data collection

Procedure: Nasopharyngeal swabs

Procedure: Cough swab

Controls

Description:

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

Treatment:

Procedure: Bronchoscopy/ bronchoalveolar lavage samples