The Use of a Forecasting System for Predicting Exacerbations of COPD

NCT00788645 | Completed Early Phase 1

• 1 other identifier: D6256M00017
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Smoking; COPD; Chronic Obstructive Lung Disease; COPD Exacerbations; Viruses and Bacteria associated with COPD exacerbations

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (3)

Forecast

EXPERIMENTAL

COPD patients receiving advice and poor weather warning

Behavioral: COPD self care advice; Behavioral: Poor weather forecast warning

No Forecast

EXPERIMENTAL

COPD patients receiving advice and poor weather warning

Behavioral: COPD self care advice

Control

NO INTERVENTION

Age matched non - COPD subjects

Interventions

COPD self care advice BEHAVIORAL

Information leaflets on COPD and thermometers to monitor the ambient temperature in the bedroom and living room

Forecast; No Forecast

Poor weather forecast warning BEHAVIORAL

Interactive automated telephone service to contact patients prior to anticipated periods of poor weather

Forecast

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current or former smokers with a diagnosis of COPD
• Having impaired lung function as measured by spirometry

You may not qualify if:

• History of asthma or nasal symptoms caused by hayfever
• No telephone
• Inability to record symptoms in an electronic diary (PDA)

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Exeter, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 21687919 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Smoking; Virus Diseases

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Infections

Study Officials

• David Halpin, MD

  Royal Devon and Exeter Hospital, Exeter, Devon, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 10, 2008
• First Posted: November 11, 2008
• Study Start: August 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: December 2, 2010

Record last verified: 2010-11

Locations

GB (1)