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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

November 10, 2008
November 30, 2010
August 2008
March 2009   (final data collection date for primary outcome measure)
  • The incidence and frequency of COPD exacerbations in each of the intervention groups [ Time Frame: December 2008 to March 2009 inclusive ] [ Designated as safety issue: No ]
  • Electronic diary symptoms using the EXACT instrument [ Time Frame: Daily recording ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00788645 on ClinicalTrials.gov Archive Site
  • Medication usage and hospital admissions [ Time Frame: Acutely ] [ Designated as safety issue: No ]
  • Changes in the St Georges Respiratory questionaire [ Time Frame: Start and end of study period ] [ Designated as safety issue: No ]
  • Severity and duration of exacerbations assessed using the EXACT instrument [ Time Frame: Daily recording ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Chronic Obstructive Pulmonary Disease (COPD)
  • 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: Forecast
    COPD patients receiving advice and poor weather warning
    Interventions:
    • Behavioral: COPD self care advice
    • Behavioral: Poor weather forecast warning
  • Experimental: No Forecast
    COPD patients receiving advice and poor weather warning
    Intervention: Behavioral: COPD self care advice
  • No Intervention: Control
    Age matched non - COPD subjects
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
98
March 2009
March 2009   (final data collection date for primary outcome measure)

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)
Both
40 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00788645
D6256M00017
No
Harsukh Parmar, MD, Early Development Director, RITA, AstraZeneca Pharmaceuticals
AstraZeneca
Not Provided
Principal Investigator: David Halpin, MD Royal Devon and Exeter Hospital, Exeter, Devon, UK
AstraZeneca
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP