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

September 21, 2013 updated by: Philip Ind, Imperial College London

Assessment of Ventilation-perfusion Abnormalities in Patients With Smoking-related Airways Disease in Stable Condition and the Effect of Bronchodilator Therapy

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

As in Brief description

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, W12 0HS
        • Imperial College Hammersmith campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: saline control
nebulized saline
Drug: nebulized saline
Active Comparator: salbutamol and ipratropium bromide nebules
salbutamol 2.5 mg and ipratropium bromide 0.5 mg
Drug: salbutamol + ipratropium bromide nebules
Other Names:
  • albuterol
  • Ventolin
  • Atrovent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
scan grade
Time Frame: post scan
previously validated grading score
post scan

Secondary Outcome Measures

Outcome Measure
Time Frame
lung function
Time Frame: pre scan
pre scan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Philip W Ind, MB BChir MRCP, Imperial College Hammersmith

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

September 24, 2013

Last Update Submitted That Met QC Criteria

September 21, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04/6741

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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