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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00180843
• Other study ID #: 04/6741
• Status: Terminated
• Phase: N/A
• First received: September 13, 2005
• Last updated: September 21, 2013
• Start date: September 2005
• Est. completion date: February 2008

Study information

• Verified date: September 2013
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

As in Brief description

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• salbutamol + ipratropium bromide nebules

• nebulized saline

Locations

Country	Name	City	State
United Kingdom	Imperial College Hammersmith Campus	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	scan grade	previously validated grading score	post scan	No
Secondary	lung function		pre scan	Yes