Experimental human pneumococcal challenge in chronic obstructive pulmonary disease and cigarette smoking

Not Applicable

Suspended

• Conditions: Streptococcus pneumoniae infection in smokers and people with chronic obstructive pulmonary disease (COPD); Infections and Infestations

• Registration Number: ISRCTN75415747
• Lead Sponsor: iverpool School of Tropical Medicine (LSTM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-27
• Last Update Posted: 25 April 2022
• Study Completion: 2023-09-02

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Inclusion criteria for healthy cigarette smokers:
1. Adults aged 18 - 50 years
2. Current regular cigarette smoker - smoking a mean average =5 cigarettes per day for the preceding 3 months
3. Fluent spoken English - to ensure a comprehensive understanding of the research project and their proposed involvement
4. Access to telephone (safety and timely communication)
5. Capacity to give informed consent

Inclusion criteria for COPD patients:
1. Adults aged 50 - 84 years
2. Either a current regular cigarette smoker - smoking a mean average =5 cigarettes per day for the preceding 3 months (SMOKER) or an ex-smoker - no regular e-cigarette, vaping or cigarette smoking in the preceding 3 months
3. Fluent spoken English - to ensure a comprehensive understanding of the research project and their proposed involvement
4. Access to telephone (safety and timely communication)
5. Diagnosis of COPD defined by Spirometry as FEV1/FVC ratio < 0.7 (post bronchodilator)
6. Capacity to give informed consent

Exclusion Criteria

Exclusion criteria for Group 1 and 2:
1. In a caring role or with intimate physical contact with at-risk individuals (children under 5yrs, immunosuppressed adults) during the period of pneumococcal colonisation
2. History of or current regular drug or alcohol abuse (frequently drinking alcohol: men and women should not regularly drink > 3-4 units/day and > 2-3 units/day respectively)
3. Taking daily medications that may affect the immune system e.g. systemic steroids, systemic corticosteroids, antibiotics, or disease-modifying anti-rheumatoid drugs
4. Any acute illness (new symptoms within preceding 14 days which are unexplained by the known past medical history)
5. Having received any antibiotics in the preceding 28 days
6. History of culture-proven pneumococcal disease
7. Involved in another clinical trial unless observational or in follow-up (non-interventional) phase
8. Have been involved in a clinical trial involving EHPC and bacterial inoculation in the past three years
9. Disease associated with altered immunity, including diabetes, alcohol abuse, malignancy, rheumatological conditions
10. At the clinician’s discretion any unstable or poorly controlled co-morbidity
11. Taking medication that affects blood clotting (except aspirin and clopidogrel) e.g. warfarin or other oral or injectable anticoagulants
12. Have any uncontrolled medical/ surgical conditions such as but not restricted to: hypertension, mental health conditions, epilepsy, narcolepsy, chronic conditions requiring pain medication such as osteoarthritis, skin conditions, allergies, hay fever, and any other condition at the discretion of the PI
13. Allergy to penicillin/amoxicillin AND clarithromycin
14. Concern of the study doctor about the participant’s health

Exclusion criteria for healthy cigarette smokers:
1. > = 20 pack year smoking history

Exclusion criteria for COPD patients:
1. < 20 pack year smoking history
2. Severe COPD (post bronchodilator FEV1/FVC < 0.7 AND FEV1 < 50% predicted post bronchodilator)
3. Reversibility of > 15% of the baseline FEV1 suggests a diagnosis of asthma and would lead to exclusion from the study
4. Acute exacerbation of COPD in the last 3 months or more than 3 exacerbations in the last 12 months requiring oral steroids and/or hospitalisation
5. On ambulatory or long-term oxygen therapy
6. Significant cardiorespiratory disease, other than COPD (excluding stable hypertension)
7. Definite diagnosis of pre-existing asthma (excluding childhood asthma)

Study & Design

• Study Type: Observational
• Study Design: Not specified