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The Use of a Forecasting System for Predicting Exacerbations of COPD

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00788645
First received: November 10, 2008
Last updated: November 30, 2010
Last verified: November 2010
  Purpose
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.

Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD) Behavioral: COPD self care advice Behavioral: Poor weather forecast warning Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Use of a Forecasting System for Predicting Exacerbations of COPD: Effect on Symptoms and Hospitalisation and Relevance of Viral Infections

Further study details as provided by AstraZeneca:

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

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

Enrollment: 98
Study Start Date: August 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00788645

Locations
United Kingdom
Research Site
Exeter, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: David Halpin, MD Royal Devon and Exeter Hospital, Exeter, Devon, UK
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Harsukh Parmar, MD, Early Development Director, RITA, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00788645     History of Changes
Other Study ID Numbers: D6256M00017
Study First Received: November 10, 2008
Last Updated: November 30, 2010

Keywords provided by AstraZeneca:
Smoking
COPD
Chronic Obstructive Lung Disease
COPD Exacerbations
Viruses and Bacteria associated with COPD exacerbations

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 18, 2017