The Use of a Forecasting System for Predicting Exacerbations of COPD

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00788645
• Other study ID #: D6256M00017
• Status: Completed
• Phase: Phase 0
• First received: November 10, 2008
• Last updated: November 30, 2010
• Start date: August 2008
• Est. completion date: March 2009

Study information

• Verified date: November 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• COPD self care advice
Information leaflets on COPD and thermometers to monitor the ambient temperature in the bedroom and living room
• Poor weather forecast warning
Interactive automated telephone service to contact patients prior to anticipated periods of poor weather

Locations

Country	Name	City	State
United Kingdom	Research Site	Exeter

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence and frequency of COPD exacerbations in each of the intervention groups		December 2008 to March 2009 inclusive	No
Primary	Electronic diary symptoms using the EXACT instrument		Daily recording	No
Secondary	Medication usage and hospital admissions		Acutely	No
Secondary	Changes in the St Georges Respiratory questionaire		Start and end of study period	No
Secondary	Severity and duration of exacerbations assessed using the EXACT instrument		Daily recording	No