NCT00180635

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, induced sputum, nasal lavage and mouth wash fluid in healthy non-smokers, current smokers and patients with COPD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Oct 2003

Typical duration for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

July 10, 2019

Status Verified

July 1, 2019

Enrollment Period

2.8 years

First QC Date

September 9, 2005

Last Update Submit

July 9, 2019

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDAminoguanidineNitric oxide

Outcome Measures

Primary Outcomes (1)

  • Bronchial exhale nitric oxide (JNO)

    Bronchial exhale nitric oxide (JNO) as assessed by Chemo luminescence

    24 hours

Study Arms (3)

Healthy volunteers non smoker

EXPERIMENTAL

Control group

Drug: AminoguanidineDrug: Placebos

Healthy volunteers smoker

EXPERIMENTAL

More than 10 pack-years

Drug: AminoguanidineDrug: Placebos

Chronic Obstructive Pulmonary Disease COPD

EXPERIMENTAL

COPD diagnosed according to the Global Initiative for Chronic Obstructive Lung Disease guidelines

Drug: AminoguanidineDrug: Placebos

Interventions

AminoguanidineDRUG

500mg

Also known as: Nebulased Aminoguanidine
Chronic Obstructive Pulmonary Disease COPDHealthy volunteers non smokerHealthy volunteers smoker
PlacebosDRUG

2ml

Also known as: Nebulase saline solution
Chronic Obstructive Pulmonary Disease COPDHealthy volunteers non smokerHealthy volunteers smoker

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy non-smokers
  • Normal spirometry (FEV1 \>90 % predicted; exhaled NO bigger than or equal to 10 ppb; flow 50 ml/s)
  • At risk (current smokers)
  • Normal spirometry, with or without chronic symptoms (cough, sputum production)
  • FEV1 reversibility of \<15% after inhaled beta2-agonists\*
  • Moderate COPD
  • FEV1 greater than or equal to 30% and \< 80%
  • FEV1/FVC \< 70% predicted
  • FEV1 reversibility of \<15% after inhaled beta2-agonists
  • With or without chronic symptoms (cough, sputum production, dyspnea)
  • Able to comprehend and grant a written informed consent

You may not qualify if:

  • Concomitant use or pre-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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital

London, SW3 6LY, United Kingdom

Location

Related Publications (1)

  • Brindicci C, Ito K, Torre O, Barnes PJ, Kharitonov SA. Effects of aminoguanidine, an inhibitor of inducible nitric oxide synthase, on nitric oxide production and its metabolites in healthy control subjects, healthy smokers, and COPD patients. Chest. 2009 Feb;135(2):353-367. doi: 10.1378/chest.08-0964. Epub 2008 Aug 21.

    PMID: 18719059RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

pimagedine

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sergei A Kharitonov, MD PhD

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 16, 2005

Study Start

October 1, 2003

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

July 10, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)