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

This study has been terminated.
(lack of resources research fellow left)
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Philip Ind, Imperial College London
ClinicalTrials.gov Identifier:
NCT00180843
First received: September 13, 2005
Last updated: September 21, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease
Drug: salbutamol + ipratropium bromide nebules
Drug: nebulized saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Assessment of Ventilation-perfusion Abnormalities in Patients With Smoking-related Airways Disease in Stable Condition and the Effect of Bronchodilator Therapy

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • scan grade [ Time Frame: post scan ] [ Designated as safety issue: No ]
    previously validated grading score


Secondary Outcome Measures:
  • lung function [ Time Frame: pre scan ] [ Designated as safety issue: Yes ]

Enrollment: 2
Study Start Date: September 2005
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

As in Brief description

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180843

Locations
United Kingdom
Imperial College Hammersmith Campus
London, United Kingdom, W12 0HS
Sponsors and Collaborators
Imperial College London
GlaxoSmithKline
Investigators
Principal Investigator: Philip W Ind, MB BChir MRCP Imperial College Hammersmith
  More Information

No publications provided

Responsible Party: Philip Ind, Consultant Physician, Imperial College London
ClinicalTrials.gov Identifier: NCT00180843     History of Changes
Other Study ID Numbers: 04/6741
Study First Received: September 13, 2005
Last Updated: September 21, 2013
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Bromides
Albuterol
Ipratropium
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on September 18, 2014