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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This study has been withdrawn prior to enrollment.
(no resources available)
Sponsor:
Collaborator:
Duska Scientific Co.
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00159315
First received: September 8, 2005
Last updated: August 12, 2008
Last verified: August 2008
History of Changes
  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

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

Resource links provided by NLM:

U.S. FDA Resources

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:

  1. Healthy non-smokers (n=12)

    • Normal spirometry
    • Forced expiratory volume in 1 second (FEV1) reversibility of < 15% after inhaled beta2-agonists*

  2. 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)

  3. Mild steroid-naïve asthma (n=30)

    • FEV1 more than or equal to 80%

  4. Mild-moderate COPD (n=30)

    • FEV1 50-80%

Exclusion Criteria:

  1. Pregnancy, breast-feeding, or planned pregnancy during the study.
  2. Fertile women not using acceptable contraceptive measures, as judged by the investigator
  3. Upper respiratory infection within the last 4 weeks
  4. Subjects who have received research medication within the previous one month
  5. Subjects unable to give informed consent
  6. 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

No publications provided

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

Keywords provided by Imperial College London:
Healthy Volunteers (smokers)
Healthy Volunteers (Non-smokers)
Asthma Patients
COPD Patients

Additional relevant MeSH terms:
Asthma
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Smoking
Lung Diseases, Obstructive
Bronchial Diseases
 Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Habits

ClinicalTrials.gov processed this record on May 22, 2013