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NO Donors and Inhibitors Study - Article


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Triamcinolone Nasal Inhalation

Nasacort; Nasacort AQ; Tri Nasal


Clinical Trial: NO Donors and Inhibitors Study

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

Sponsored by: Imperial College London
Information provided by: Imperial College London
ClinicalTrials.gov Identifier: NCT00159380

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
Healthy volunteers
 Procedure: Inhalation of aminoguanidine and oral intake and inhalation of L-arginine
 Procedure: Exhaled Breath Condensate
 Procedure: Nasal Lavage
 Procedure: Saliva
 Procedure: Spirometry

MedlinePlus related topics:  Asthma

Study Type: Interventional
Study Design: Randomized, Double-Blind, Placebo Control, Crossover Assignment

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

Further Study Details: 
Primary Outcomes: Exhaled Nitric Oxide, Exhaled Breath Condensate, Nasal Lavage, Saliva, Spirometry
Expected Total Enrollment:  25

Study start: September 2003

Eligibility

Ages Eligible for Study:  21 Years   -   60 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

Healthy non-smokers (n=10) • Non atopic subjects (exhaled NO bigger 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) • FEV1 of no less 70% of predicted (exhaled NO bigger 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:

• Current 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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00159380

Sergei A Kharitonov, MD PhD      020 7351 8006  Ext. 8006    s.kharitonov@imperial.ac.uk
Caterina Brindicci, MD      020 7351 8051  Ext. 8051    c.brindicci@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 
Caterina Brindicci, MD  020 7351 8051  Ext. 8051    c.brindicci@imperial.ac.uk 
Sergei A Kharitonov, MD PhD,  Principal Investigator
Caterina Brindicci, MD,  Sub-Investigator
Kazuhiro A Ito, PhD,  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:  2002AT033B
Last Updated:  September 11, 2005
Record first received:  September 9, 2005
ClinicalTrials.gov Identifier:  NCT00159380
Health Authority: United Kingdom: Research Ethics Committee
ClinicalTrials.gov processed this record on 2005-09-13


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September 5, 2008



Page Updated: June 1, 2005
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