Assessment of epithelial permeability in asthma through nuclear imaging

Not Applicable

Completed

• Conditions: Asthma; Respiratory

• Registration Number: ISRCTN86496888
• Lead Sponsor: Southampton University Hospitals NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-28
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

General:
1. Subject must understand the procedures of the study and agree to participation in the study by providing written informed consent
2. Subject considered fit enough to undergo lung function testing including provocation tests
3. Either gender
4. Age 18 - 55 years at screening

Group specific:
1. Healthy controls:
1.1. Lifelong non-smoker
1.2. No history suggestive of airways disease
1.3. Normal spirometry, normal exhaled nitric oxide (NO), provocative concentration causing a 20% fall in forced expiratory volume in one second (FEV1) (PC20) (metacholine) greater than 8 mg/ml (non-cumulative)
1.4. No signs of concurrent respiratory infection at time of scanning or within previous 8 weeks
1.5. No significant cardiopulmonary/hepatic or renal co-morbidity
2. Smokers:
2.1. Daily smokers of tobacco cigarettes
2.2. Normal spirometry, normal exhaled NO, PC20 (metacholine) greater than 8 mg/ml (non-cumulative)
2.3. No signs of concurrent respiratory infection at time of scanning or within previous 8 weeks
3. Asthmatics - controlled:
3.1. Asthma defined as per BTS guidelines, on treatment with inhaled corticosteroids +/- long-acting beta-agonists
3.2. Lifelong non-smokers (never smoked)
3.3. Clinically stable with FEV1 greater than 70% post-bronchodilator use, with use of rescue bronchodilators less than 3 x week
3.4. No signs of concurrent respiratory infection at time of scanning or within previous 8 weeks
4. Asthmatics - uncontrolled:
4.1. Asthma defined as per BTS guidelines, on treatment with inhaled corticosteroids +/- long-acting beta-agonists
4.2. Lifelong non-smokers (never smoked)
4.3. Use of rescue bronchodilator greater than 3 times a week
4.4. No signs of concurrent respiratory infection at time of scanning or within previous 8 weeks

Exclusion Criteria

1. Pregnancy (where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotrophin [hCG] laboratory test greater than 5 mIU/ml), an intention to become pregnant or breast-feeding (lactating)
2. Subjects with active lung disease other than asthma
3. Significant medical co-morbidity which in the view of the investigator could impact on the interpretation of results or participation in the trial
4. Active cancer or a history of cancer or radiotherapy
5. Current/previous users of recreational inhaled illicit drugs, e.g. cannabis, crack cocaine, etc.
6. Inability to lie flat for scan for 2 hours
7. Those who have participated in a clinical trial involving an investigational or marketed drug within 12 weeks of screening, or participated in any study involving radiation within 12 months of screening
8. Those in any situation which, in the opinion of the investigator, may interfere with optimal participation in the study
9. Those unable to optimally perform the breathing manoeuvres required for lung function testing, or deposition of the radio-labelled aerosol
10. Signs of concurrent respiratory tract infection on examination at the time of scanning or within previous 8 weeks (can be rescreened after 8 weeks if otherwise eligible)

Study & Design

• Study Type: Observational
• Study Design: Not specified