Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
• 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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cases | Subjects diagnosed with chronic cough who are undergoing general anaesthesia and bronchoscopy/BAL as part of the diagnostic process for chronic cough. |
| |
| Controls | Subjects without respiratory symptoms who are undergoing general anaesthesia for elective surgery or endoscopy of non-respiratory-related conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cough swab | Procedure | Samples will be tested to determine and characterise the bacteria that may be associated with chronic cough. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
In addition, all subjects regarded as 'cases' must satisfy all the following criteria at study entry:
In addition, all subjects regarded as 'controls' must satisfy the following criteria at study entry:
Exclusion Criteria:
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Belfast | BT12 6BE | United Kingdom | |||
| GSK Investigational Site |
Not provided
Not provided
Not provided
Not provided
Cough swab, oropharyngeal swab, nasopharyngeal swabs, blood and bronchoscopy/ bronchoalveolar lavage samples.
| Oropharyngeal swab | Procedure | Samples will be tested to determine and characterise the bacteria that may be associated with chronic cough. |
|
| Nasopharyngeal swabs | Procedure | Samples will be tested to determine and characterise the bacteria and viruses that may be associated with chronic cough. |
|
| Blood sample | Procedure | Samples will be tested to determine and characterise the immunological markers that may be associated with chronic cough. |
|
| 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. |
|
| Data collection | Other | Questionnaire completion. |
|
| 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 |
| Occurrence of Haemophilus haemolyticus in the lower airways and nasopharynx/ oropharynx of cases and controls | 12-15 months from study initiation |
| Antimicrobial resistance of Haemophilus influenzae in lower airways | 12-15 months from study initiation |
| Occurrence of viral pathogens in the lower airways and nasopharynx of cases and controls | 12-15 months from study initiation |
| Occurrence of Moraxella catarrhalis in the lower airways of cases and controls | 12-15 months from study initiation |
| Occurrence of other bacterial pathogens in the lower airways of cases and controls | 12-15 months from study initiation |
| Occurrence of Streptococcus pneumoniae in cough swabs and nasopharynx/ oropharynx of cases and controls | 12-15 months from study initiation |
| Occurrence of Moraxella catarrhalis in cough swabs and nasopharynx/ oropharynx of cases and controls | 12-15 months from study initiation |
| Occurrence of Streptococcus pneumoniae in the lower airways and/or nasopharynx/ oropharynx of cases and controls | 12-15 months from study initiation |
| Occurrence of other bacterial pathogens in the lower airways and/or nasopharynx/ oropharynx of cases and controls | 12-15 months from study initiation |
| Bacterial load of Streptococcus pneumoniae in the lower airways and nasopharynx/ oropharynx of cases and controls | 12-15 months from study initiation |
| Bacterial load of Moraxella catarrhalis in the lower airways and nasopharynx/ oropharynx of cases and controls | 12-15 months from study initiation |
| Occurrence of serotypes of Haemophilus influenzae in the lower airways and nasopharynx/ oropharynx of cases and controls | 12-15 months from study initiation |
| Occurrence of serotypes of Streptococcus pneumoniae in the lower airways and nasopharynx/ oropharynx of cases and controls | 12-15 months from study initiation |
| Antimicrobial resistance of Streptococcus pneumoniae in lower airways | 12-15 months from study initiation |
| Antimicrobial resistance of Moraxella catarrhalis in lower airways | 12-15 months from study initiation |
| Bristol |
| BS2 8AE |
| United Kingdom |
| GSK Investigational Site | Sheffield | S10 2TH | United Kingdom |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D000096822 | Chronic Cough |
| D006192 | Haemophilus Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D003371 | Cough |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016871 | Pasteurellaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
Not provided
Not provided
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D001999 | Bronchoscopy |
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D003948 | Diagnostic Techniques, Respiratory System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013510 | Pulmonary Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
Not provided
Not provided