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Nitric Oxide (NO) Donors and Inhibitors Study: Study to Evaluate L-Arginine and Aminoguanidine in Asthmatic Subjects

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ClinicalTrials.gov Identifier: NCT00159380
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : June 4, 2015
Sponsor:
Information provided by:
Imperial College London

Brief Summary:
The primary aim of this study is to investigate the effects of oral and inhaled administration of L-arginine and of inhaled aminoguanidine on bronchial and alveolar exhaled NO and NO metabolites in exhaled breath condensate, saliva and nasal lavage fluid in normal and asthmatic subjects.

Condition or disease Intervention/treatment
Asthma Procedure: Inhalation of aminoguanidine and oral intake and inhalation of L-arginine Procedure: Exhaled Breath Condensate Procedure: Nasal Lavage Procedure: Saliva Procedure: Spirometry

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Official Title: A Double Blind, Crossover Placebo-controlled Study to Evaluate the Effect of L-arginine and Aminoguanidine on Bronchial, Alveolar and Nasal NO and NO Metabolites in Exhaled Air, Breath Condensate, Saliva, Nasal Lavage Fluid and Induced Sputum in 10 Normal and 15 Asthmatic Subjects
Study Start Date : September 2003
Primary Completion Date : March 2005
Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Arginine
U.S. FDA Resources




Primary Outcome Measures :
  1. Exhaled nitric oxide, exhaled breath condensate, nasal lavage, saliva, spirometry


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy non-smokers (n=10):

  • Nonatopic subjects (exhaled NO greater than or equal to 10 ppb; flow 50 ml/s)
  • Normal spirometry
  • Able to comprehend and grant a written informed consent

Asthmatic subjects (n=15):

  • Forced expiratory volume in one second (FEV1) of no less than 70% of predicted (exhaled NO greater than or equal to 15 ppb; flow 50 ml/s)
  • Clinically stable (steroid-naïve or taking no > 600 mcg/day of inhaled steroids)
  • Able to comprehend and grant a written informed consent

Exclusion Criteria:

  • Currently smoking
  • Any lung disease other than asthma which may interfere with the study
  • Treatment within the last 4 weeks with oral steroids
  • Respiratory infection within 4 weeks prior to entry into the trial
  • Females who are pregnant or lactating
  • History of current or past drug or alcohol abuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00159380


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

ClinicalTrials.gov Identifier: NCT00159380     History of Changes
Other Study ID Numbers: 2002AT033B
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: April 2008

Keywords provided by Imperial College London:
Healthy Volunteers

Additional relevant MeSH terms:
Pimagedine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action