Clinical trial NCT00788645: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Smoking
COPD
Chronic Obstructive Lung Disease
COPD Exacerbations
Viruses and Bacteria associated with COPD exacerbations
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-11-11
Enrollment: 98
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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)

Primary outcomes:
measure: The incidence and frequency of COPD exacerbations in each of the intervention groups
timeFrame: December 2008 to March 2009 inclusive
measure: Electronic diary symptoms using the EXACT instrument
timeFrame: Daily recording
Secondary outcomes:
measure: Medication usage and hospital admissions
timeFrame: Acutely
measure: Changes in the St Georges Respiratory questionaire
timeFrame: Start and end of study period
measure: Severity and duration of exacerbations assessed using the EXACT instrument
timeFrame: Daily recording
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Royal Devon and Exeter Hospital, Exeter, Devon, UK
name: David Halpin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.