The Use of a Forecasting System for Predicting Exacerbations of COPD

The Use of a Forecasting System for Predicting Exacerbations of COPD: Effect on Symptoms and Hospitalisation and Relevance of Viral Infections

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Behavioral: COPD self care advice; Behavioral: Poor weather forecast warning

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Exeter, United Kingdom
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Forecast; COPD patients receiving advice and poor weather warning	Behavioral: COPD self care advice; Information leaflets on COPD and thermometers to monitor the ambient temperature in the bedroom and living room; Behavioral: Poor weather forecast warning; Interactive automated telephone service to contact patients prior to anticipated periods of poor weather
Experimental: No Forecast; COPD patients receiving advice and poor weather warning	Behavioral: COPD self care advice; Information leaflets on COPD and thermometers to monitor the ambient temperature in the bedroom and living room
No Intervention: Control; Age matched non - COPD subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The incidence and frequency of COPD exacerbations in each of the intervention groups	December 2008 to March 2009 inclusive
Electronic diary symptoms using the EXACT instrument	Daily recording

Secondary Outcome Measures

Outcome Measure	Time Frame
Medication usage and hospital admissions	Acutely
Changes in the St Georges Respiratory questionaire	Start and end of study period
Severity and duration of exacerbations assessed using the EXACT instrument	Daily recording

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: David Halpin, MD, Royal Devon and Exeter Hospital, Exeter, Devon, UK

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: November 10, 2008
• First Submitted That Met QC Criteria: November 10, 2008
• First Posted (Estimate): November 11, 2008

Study Record Updates

• Last Update Posted (Estimate): December 2, 2010
• Last Update Submitted That Met QC Criteria: November 30, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: COPD; Smoking; Chronic Obstructive Lung Disease; COPD Exacerbations; Viruses and Bacteria associated with COPD exacerbations
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: D6256M00017