Nitric Oxide (NO) Donors and Inhibitors Study: Study to E... | NCT00159380

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

NCT00159380

Sponsor

Imperial College London

Status

Completed

Last Update Posted

Jul 10, 2019Actual

Enrollment

16Actual

Phase

Not Applicable

Conditions

Asthma

Interventions

Aminoguanidine
Placebos

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2003Actual

Primary Completion Date

Mar 2005Actual

Completion Date

Mar 2005Actual

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2019

Last Update Posted Date

Jul 10, 2019Actual

Description Module

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.

Detailed Description

Nitric oxide (NO) is produced by a variety of cells within the respiratory tract, particularly airway epithelial cells, and its increased concentration in asthma is likely to derive from inducible NO synthase (iNOS) expressed in inflamed airways. To evaluate whether an increased bronchial flux of NO (ie, airway wall NO flux [Jno] in picoliters per second) produced in the large airways is due to an enzyme overexpression, we administered a relatively selective iNOS inhibitor, aminoguanidine, by nebulization in a double-blind, placebo-controlled manner in asthmatic and healthy subjects and also investigated whether the same concentration of inhibitor has any effect on NO produced in the peripheral lungs (ie, alveolar NO concentration [Calv] in parts per billion [ppb]) or on the diffusing capacity of NO (Dno) [in picoliters per second-1 per ppb-1) in the airways. Aminoguanidine administration resulted in a significant reduction in Jno compared with administration of the saline solution control in eight healthy subjects and in eight patients with asthma but caused no significant changes in Calv or in Dno in either group.](streamdown:incomplete-link)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy volunteers	Experimental	8 non smokers non asthmatic	Drug: Placebos
Asthma volunteers	Experimental	8 asthmatic mild	Drug: Aminoguanidine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aminoguanidine	Drug	500mg	Asthma volunteers	Inhalation of aminoguanidine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bronchial exhale nitric oxide	Bronchial exhale nitric oxide (JNo) assessed by chemo luminescence	6 hours
Peripheral exhaled nitric oxide	Peripheral exhaled nitric oxide(CALV) assessed by chemo luminescence	6 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sergei A Kharitonov, MD, PhD	Imperial College London	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital		London		SW3 6LY	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17550932	Result	Brindicci C, Ito K, Barnes PJ, Kharitonov SA. Effect of an inducible nitric oxide synthase inhibitor on differential flow-exhaled nitric oxide in asthmatic patients and healthy volunteers. Chest. 2007 Aug;132(2):581-8. doi: 10.1378/chest.06-3046. Epub 2007 Jun 5.

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases