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

NCT00180843 | Terminated

• 1 other identifier: 04/6741
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• scan grade

  previously validated grading score

  post scan

Secondary Outcomes (1)

• lung function

  pre scan

Study Arms (2)

saline control

PLACEBO COMPARATOR

nebulized saline

Drug: nebulized saline

salbutamol and ipratropium bromide nebules

ACTIVE COMPARATOR

salbutamol 2.5 mg and ipratropium bromide 0.5 mg

Drug: salbutamol + ipratropium bromide nebules

Interventions

salbutamol + ipratropium bromide nebules DRUG

Also known as: albuterol, Ventolin, Atrovent

salbutamol and ipratropium bromide nebules

nebulized saline DRUG

saline control

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Imperial College Hammersmith Campus

London, London, W12 0HS, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Albuterol; Ipratropium

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Philip W Ind, MB BChir MRCP

  Imperial College Hammersmith

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Physician

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: September 1, 2005
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: September 24, 2013

Record last verified: 2013-09

Locations

GB (1)