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Assessment of Ventilation-perfusion Abnormalities in Patients With Stable Smoking-related Airways Disease

NCT ID: NCT00180843

Last Updated: 2013-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2008-02-29

Brief Summary

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Subjects undergo history, examination, lung function assessment after informed consent has been obtained. All subjects will undergo ventilation-perfusion scans. If there first scan is normal they will undergo a second and final scan four weeks later. If abnormal they will undergo two further scans with either nebulized bronchodilator or nebulized saline prior to their second and third scans. Each time they will have repeat lung function tests prior to scanning. We will examine the regional changes in ventilation and perfusion and there relationship to lung function.

Detailed Description

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As in Brief description

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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saline control

nebulized saline

Group Type PLACEBO_COMPARATOR

nebulized saline

Intervention Type DRUG

salbutamol and ipratropium bromide nebules

salbutamol 2.5 mg and ipratropium bromide 0.5 mg

Group Type ACTIVE_COMPARATOR

salbutamol + ipratropium bromide nebules

Intervention Type DRUG

Interventions

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salbutamol + ipratropium bromide nebules

Intervention Type DRUG

nebulized saline

Intervention Type DRUG

Other Intervention Names

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albuterol Ventolin Atrovent

Eligibility Criteria

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Inclusion Criteria

* FEV1 \< 70% predicted at baseline on spirometry
* significant smoking history or alpha 1 antitrypsin deficiency
* no evidence of current infection or restrictive lung disease

Exclusion Criteria

* history of other significant respiratory disease
* significant respiratory infection within 6 weeks
* history of significant physical or mental illness rendering them unfit for the study in the opinion of the investigator
* taken part in any other research within the past 12 months, or received exposure to ionizing radiation
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Philip Ind

Consultant Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Philip W Ind, MB BChir MRCP

Role: PRINCIPAL_INVESTIGATOR

Imperial College Hammersmith

Locations

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Imperial College Hammersmith Campus

London, London, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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04/6741

Identifier Type: -

Identifier Source: org_study_id