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Fluticasone Powder for Oral Inhalation |
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Clinical Trial: NO Donors and Inhibitors Study
This study is currently recruiting patients.
Verified by Imperial College London September 2005
|
Purpose
| 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
Expected Total Enrollment: 25
Study start: September 2003
Eligibility
Accepts Healthy Volunteers
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
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
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
Sergei A Kharitonov, MD PhD, Principal Investigator, Imperial College London
More Information
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
Resources
- Flovent Rotadisk (Drug Digest)
- Fluticasone Powder for Oral Inhalation (Drug Digest)
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