Back to resultsAssessment of Ventilation-perfusion Abnormalities in Patients With Stable Smoking-related Airways Disease
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
salbutamol + ipratropium bromide nebules
nebulized saline
Sponsored by
About this trial
This is an interventional basic science trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
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
Sites / Locations
- Imperial College Hammersmith Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
saline control
salbutamol and ipratropium bromide nebules
Arm Description
nebulized saline
salbutamol 2.5 mg and ipratropium bromide 0.5 mg
Outcomes
Primary Outcome Measures
scan grade
previously validated grading score
Secondary Outcome Measures
lung function
Full Information
NCT ID
NCT00180843
First Posted
September 13, 2005
Last Updated
September 21, 2013
Sponsor
Imperial College London
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00180843
Brief Title
Assessment of Ventilation-perfusion Abnormalities in Patients With Stable Smoking-related Airways Disease
Official Title
Assessment of Ventilation-perfusion Abnormalities in Patients With Smoking-related Airways Disease in Stable Condition and the Effect of Bronchodilator Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Terminated
Why Stopped
lack of resources research fellow left
Study Start Date
September 2005 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Imperial College London
Collaborators
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
As in Brief description
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
saline control
Arm Type
Placebo Comparator
Arm Description
nebulized saline
Arm Title
salbutamol and ipratropium bromide nebules
Arm Type
Active Comparator
Arm Description
salbutamol 2.5 mg and ipratropium bromide 0.5 mg
Intervention Type
Drug
Intervention Name(s)
salbutamol + ipratropium bromide nebules
Other Intervention Name(s)
albuterol, Ventolin, Atrovent
Intervention Type
Drug
Intervention Name(s)
nebulized saline
Primary Outcome Measure Information:
Title
scan grade
Description
previously validated grading score
Time Frame
post scan
Secondary Outcome Measure Information:
Title
lung function
Time Frame
pre scan
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip W Ind, MB BChir MRCP
Organizational Affiliation
Imperial College Hammersmith
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imperial College Hammersmith Campus
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Assessment of Ventilation-perfusion Abnormalities in Patients With Stable Smoking-related Airways Disease
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