ATP/AMP Challenge in Healthy Non-Smokers, Smokers, Patients With Asthma, and Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study has been withdrawn prior to recruitment.

Sponsors and Collaborators:	Imperial College London Duska Scientific Co.
Information provided by:	Imperial College London
ClinicalTrials.gov Identifier:	NCT00159315

Purpose

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 patients with mild-moderate COPD.

Each subject will have 1 screening visit (if necessary) and 2 study visits. At visits 2 and 3 the effects of adenosine 5`-triphosphate (ATP) or adenosine 5`-monophosphate (AMP) challenge, given in a random order, will be tested.

Condition	Intervention
Asthma COPD Smoking	Procedure: Inhalation Challenge with ATP Procedure: Inhalation Challenge with AMP

MedlinePlus related topics: Asthma COPD (Chronic Obstructive Pulmonary Disease) Smoking

Drug Information available for: Adenosine Adenosine triphosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Crossover Assignment
Official Title:	Adenosine 5`-Triphosphate (ATP) Challenge in Healthy Non-Smokers, Current Smokers and Patients With Mild Asthma and Chronic Obstructive Pulmonary Disease (COPD)

Further study details as provided by Imperial College London:

Primary Outcome Measures:

PC20 of ATP and AMP
Lung function
Borg score
Impulse oscillometry (IOS)

Estimated Enrollment:	84
Study Start Date:	October 2002

Eligibility

Ages Eligible for Study:	21 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00159315

Locations

United Kingdom
Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital
London, United Kingdom, SW3 6LY

Sponsors and Collaborators

Imperial College London

Duska Scientific Co.

Investigators

Principal Investigator:

Sergei A Kharitonov, MD, PhD

Imperial College London

More Information

Study ID Numbers:	DHTABPT0336
Study First Received:	September 8, 2005
Last Updated:	August 12, 2008
ClinicalTrials.gov Identifier:	NCT00159315
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:

Healthy Volunteers (smokers)
Healthy Volunteers (Non-smokers)
Asthma Patients
COPD Patients

Study placed in the following topic categories:

Smoking
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate

Asthma
Healthy
Adenosine
Respiratory Hypersensitivity
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on January 14, 2009