Markers for Chronic Obstructive Pulmonary Disease (COPD) | NCT00180622

Studies
Markers for Chronic Obstructive Pulmonary Disease (COPD)

NCT00180622

Sponsor

Imperial College London

Status

Withdrawn

Last Update Posted

Jul 5, 2019Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Healthy Non-smokers
Current Smokers
COPD Patients

Interventions

Spirometry
Exhaled Nitric Oxide and Carbon Monoxide
Exhaled Breath Condensate
Induced Sputum
CT Scan
Blood test
St Georges Questionnaire
Bodypletysmography

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

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No resources available

Expanded Access Info

Start Date

Jul 1, 2001Estimated

Primary Completion Date

Jul 1, 2002Estimated

Completion Date

Jul 1, 2002Estimated

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 16, 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 2, 2019

Last Update Posted Date

Jul 5, 2019Actual

Name	Class
AstraZeneca	INDUSTRY

Description Module

Brief Summary

The primary aim of this study is to exploit a difference between COPD patients, chronic smokers without COPD and healthy non-smoking subjects. This will help to assess the utility of inflammatory and oxidative markers in exhaled air and sputum and to compare them with the lung function, clinical parameters and computerised tomography (CT).

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Spirometry	Procedure
Exhaled Nitric Oxide and Carbon Monoxide	Procedure
Exhaled Breath Condensate	Procedure
Induced Sputum	Procedure
CT Scan	Procedure
Blood test	Procedure
St Georges Questionnaire	Procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy non-smokers

FEV1 >80% predicted
FEV1 reversibility of <10% after inhaled (beta2-agonists

Current smokers

FEV1 no less than 80% predicted
FEV1 reversibility of <10% after inhaled (beta2-agonists
Smoking history of > 10 pack-years

Moderate COPD

FEV1 40-59% predicted
FEV1 reversibility of <10% after inhaled (beta2-agonists
Smoking history of > 10 pack-years**

Severe COPD

FEV1 <40% predicted
FEV1 reversibility of <10% after inhaled (beta2-agonists
Smoking history of > 10 pack-years

Exclusion Criteria:

FEV1 increases by 200 ml and 15% of the baseline value after inhaled (beta2-agonists
Asthma
unstable disease (FEV1 <35% predicted) and/or current, or within the last 4 weeks, respiratory tract infection.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

75 Years

Standard Ages

AdultOlder 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
Peter J Barnes, MA DM DSc FRCP	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

Intervention Browse Module

MeSH Terms

ID	Term
D002248	Carbon Monoxide
D006403	Hematologic Tests

Ancestor Terms

ID	Term
D017554	Carbon Compounds, Inorganic
D007287	Inorganic Chemicals
D005740	Gases
D010087	Oxides

Browse Leaves

Not provided

Browse Branches

Not provided