Status:
COMPLETED
ATP/AMP Challenge in Healthy Non-smokers, Smokers, Patients With Asthma, and Patients With Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Duska Scientific Co.
Conditions:
Asthma
COPD
Eligibility:
All Genders
21-85 years
Phase:
NA
Brief Summary
In this randomised, cross-over, controlled study, a total of 84 subjects will be included: 12 healthy non-smoking volunteers; 12 current smokers; 30 patients with mild steroid-naïve asthma; and 30 pat...
Detailed Description
Background: Extracellular adenosine 5'-triphosphate (ATP) stimulates vagal C and Aδ fibers in the lung, resulting in pronounced bronchoconstriction and cough mediated by P2X2/3 receptors located on va...
Eligibility Criteria
Inclusion
- Healthy non-smokers (n=12)
- Normal spirometry
- Forced expiratory volume in 1 second (FEV1) reversibility of \< 15% after inhaled beta2-agonists\*
- At risk (current smokers) (n=12)\*
- Normal spirometry, chronic symptoms (cough, sputum production)
- FEV1 reversibility of \< 15% after inhaled beta2-agonists\* (\* = Global Strategy for the Diagnosis, Management, and Prevention of COPD)
- Mild steroid-naïve asthma (n=30)
- FEV1 more than or equal to 80%
- Mild-moderate COPD (n=30)
- FEV1 50-80%
Exclusion
- Pregnancy, breast-feeding, or planned pregnancy during the study.
- Fertile women not using acceptable contraceptive measures, as judged by the investigator
- Upper respiratory infection within the last 4 weeks
- Subjects who have received research medication within the previous one month
- Subjects unable to give informed consent
- Any psychiatric condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2004
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00159315
Start Date
October 1 2002
End Date
October 1 2004
Last Update
April 4 2024
Active Locations (1)
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1
Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital
London, United Kingdom, SW3 6LY