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

September 9, 2005
April 4, 2008
September 2003
March 2005   (final data collection date for primary outcome measure)
Exhaled nitric oxide, exhaled breath condensate, nasal lavage, saliva, spirometry
Same as current
Complete list of historical versions of study NCT00159380 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Nitric Oxide (NO) Donors and Inhibitors Study: Study to Evaluate L-Arginine and Aminoguanidine in Asthmatic Subjects
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Asthma
  • Procedure: Inhalation of aminoguanidine and oral intake and inhalation of L-arginine
  • Procedure: Exhaled Breath Condensate
  • Procedure: Nasal Lavage
  • Procedure: Saliva
  • Procedure: Spirometry
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
March 2005
March 2005   (final data collection date for primary outcome measure)

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
Both
21 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00159380
2002AT033B
Not Provided
Not Provided
Imperial College London
Not Provided
Principal Investigator: Sergei A Kharitonov, MD, PhD Imperial College London
Imperial College London
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP