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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
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

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

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
November 10, 2008
Last Updated
November 30, 2010
Sponsor
AstraZeneca
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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
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The Use of a Forecasting System for Predicting Exacerbations of COPD

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