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

This study has been completed.
Sponsor:
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00159380
First received: September 9, 2005
Last updated: April 4, 2008
Last verified: April 2008
  Purpose

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 Intervention
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
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Imperial College London:

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

Estimated Enrollment: 25
Study Start Date: September 2003
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00159380     History of Changes
Other Study ID Numbers: 2002AT033B
Study First Received: September 9, 2005
Last Updated: April 4, 2008
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
Healthy Volunteers

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

ClinicalTrials.gov processed this record on September 18, 2014