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ATP/AMP Challenge in Healthy, Smokers, Asthma, COPD - Article


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Asthma & Allergies

 




Clinical Trial: ATP/AMP Challenge in Healthy, Smokers, Asthma, COPD

This study is currently recruiting patients.
Verified by Imperial College London September 2005

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 effect of ATP or AMP challenge given in a random order will be tested.

Condition Intervention
Healthy Volunteers (smokers)
Healthy Volunteers (Non-smokers)
Asthma Patients
COPD patients
 Procedure: Inhalation Challenge with ATP and AMP

MedlinePlus consumer health information 

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: 
Primary Outcomes: PC20 of ATP and AMP, Lung Function, Borg Score, Impulse Oscillometry (IOS)
Expected Total Enrollment:  84

Study start: October 2002

Eligibility

Ages Eligible for Study:  21 Years   -   85 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

  1. Healthy non-smokers (n=12)

    • Normal spirometry
    • FEV1 reversibility of <15% after inhaled beta2-agonists*
  2. 0: 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 % FEV1

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.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00159315

Sergei A Kharitonov, MD PhD      020 7351 8006  Ext. 8006    s.kharitonov@imperial.ac.uk
Pilar Ausin, MD      020 7351 8051  Ext. 8051    p.ausin@imperial.ac.uk

United Kingdom
      Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital, London,  SW3 6LY,  United Kingdom; Recruiting
Sergei A Kharitonov, MD PhD  020 7351 8006  Ext. 8006    s.kharitonov@imperial.ac.uk 
Pilar Ausin, MD  020 7351 8051  Ext. 8051    p.ausin@imperial.ac.uk 
Sergei A Kharitonov, MD PhD,  Principal Investigator
Pilar Ausin, MD,  Sub-Investigator
Peter J Barnes, MA DM DSc FRCP,  Principal Investigator

Study chairs or principal investigators

Sergei A Kharitonov, MD PhD,  Principal Investigator,  Imperial College London   

More Information

Study ID Numbers:  DHTABPT0336
Last Updated:  September 11, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00159315
Health Authority: United Kingdom: Research Ethics Committee
ClinicalTrials.gov processed this record on 2005-09-13

Resources



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