The Use of a Forecasting System for Predicting Exacerbations of COPD
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Completed
Phase
Early Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
COPD self care advice
Poor weather forecast warning
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Smoking, COPD, Chronic Obstructive Lung Disease, COPD Exacerbations, Viruses and Bacteria associated with COPD exacerbations
Eligibility Criteria
Inclusion Criteria:
- Current or former smokers with a diagnosis of COPD
- Having impaired lung function as measured by spirometry
Exclusion Criteria:
- History of asthma or nasal symptoms caused by hayfever
- No telephone
- Inability to record symptoms in an electronic diary (PDA)
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Forecast
No Forecast
Control
Arm Description
COPD patients receiving advice and poor weather warning
COPD patients receiving advice and poor weather warning
Age matched non - COPD subjects
Outcomes
Primary Outcome Measures
The incidence and frequency of COPD exacerbations in each of the intervention groups
Electronic diary symptoms using the EXACT instrument
Secondary Outcome Measures
Medication usage and hospital admissions
Changes in the St Georges Respiratory questionaire
Severity and duration of exacerbations assessed using the EXACT instrument
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00788645
Brief Title
The Use of a Forecasting System for Predicting Exacerbations of COPD
Official Title
The Use of a Forecasting System for Predicting Exacerbations of COPD: Effect on Symptoms and Hospitalisation and Relevance of Viral Infections
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
People with Chronic Obstructive Pulmonary Disease (COPD) often have periods during the year when their symptoms become worse. These are often due to an infection and are called "exacerbations" by doctors. Exacerbations are more common in the winter and also seem to be related to particular types of weather. As well as forecasting the weather the UK Met Office has developed a system to try to predict when exacerbations are likely to occur. The main purpose of this research study is to find out whether the Met Office forecasting service can predict when exacerbations are more likely to occur and whether the advice given during the predicted higher risk periods leads to fewer patients having an exacerbation or if it reduces the impact of the exacerbation. The study will also assess if there is a link between viral or bacterial infection and breathing problems that occur during the study period. The study will also collect information about possible causes of the breathing problems and what happens to the person afterwards. The results of this study will help us learn more about breathing problems which may lead to new research studies that would aim to improve the care of people with COPD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Smoking, COPD, Chronic Obstructive Lung Disease, COPD Exacerbations, Viruses and Bacteria associated with COPD exacerbations
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Forecast
Arm Type
Experimental
Arm Description
COPD patients receiving advice and poor weather warning
Arm Title
No Forecast
Arm Type
Experimental
Arm Description
COPD patients receiving advice and poor weather warning
Arm Title
Control
Arm Type
No Intervention
Arm Description
Age matched non - COPD subjects
Intervention Type
Behavioral
Intervention Name(s)
COPD self care advice
Intervention Description
Information leaflets on COPD and thermometers to monitor the ambient temperature in the bedroom and living room
Intervention Type
Behavioral
Intervention Name(s)
Poor weather forecast warning
Intervention Description
Interactive automated telephone service to contact patients prior to anticipated periods of poor weather
Primary Outcome Measure Information:
Title
The incidence and frequency of COPD exacerbations in each of the intervention groups
Time Frame
December 2008 to March 2009 inclusive
Title
Electronic diary symptoms using the EXACT instrument
Time Frame
Daily recording
Secondary Outcome Measure Information:
Title
Medication usage and hospital admissions
Time Frame
Acutely
Title
Changes in the St Georges Respiratory questionaire
Time Frame
Start and end of study period
Title
Severity and duration of exacerbations assessed using the EXACT instrument
Time Frame
Daily recording
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Current or former smokers with a diagnosis of COPD
Having impaired lung function as measured by spirometry
Exclusion Criteria:
History of asthma or nasal symptoms caused by hayfever
No telephone
Inability to record symptoms in an electronic diary (PDA)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Halpin, MD
Organizational Affiliation
Royal Devon and Exeter Hospital, Exeter, Devon, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Exeter
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
21687919
Citation
Halpin DM, Laing-Morton T, Spedding S, Levy ML, Coyle P, Lewis J, Newbold P, Marno P. A randomised controlled trial of the effect of automated interactive calling combined with a health risk forecast on frequency and severity of exacerbations of COPD assessed clinically and using EXACT PRO. Prim Care Respir J. 2011 Sep;20(3):324-31, 2 p following 331. doi: 10.4104/pcrj.2011.00057.
Results Reference
derived
Learn more about this trial
The Use of a Forecasting System for Predicting Exacerbations of COPD
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