Chronic Obstructive Pulmonary Disease (COPD)Early Phase 1NCT00788645
The Use of a Forecasting System for Predicting Exacerbations of COPD
A Early Phase 1 study testing COPD self care advice and Poor weather forecast warning in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- COPD self care advice and Poor weather forecast warning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2008to Mar 2009
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current or former smokers with a diagnosis of COPD
- Having impaired lung function as measured by spirometry
Who cannot join
- History of asthma or nasal symptoms caused by hayfever
- No telephone
- Inability to record symptoms in an electronic diary (PDA)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- COPD self care advice, Poor weather forecast warning
- Keywords
- Smoking, COPD, Chronic Obstructive Lung Disease, COPD Exacerbations, Viruses and Bacteria associated with COPD exacerbations
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Smoking, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COPD self care adviceBehavioural
Information leaflets on COPD and thermometers to monitor the ambient temperature in the bedroom and living room
Poor weather forecast warningBehavioural
Interactive automated telephone service to contact patients prior to anticipated periods of poor weather
| Study group | Role | What they receive |
|---|---|---|
| Forecast | Experimental | COPD patients receiving advice and poor weather warning Receives: Behavioral: COPD self care advice; Behavioral: Poor weather forecast warning |
| No Forecast | Experimental | COPD patients receiving advice and poor weather warning Receives: Behavioral: COPD self care advice |
| Control | No intervention | Age matched non - COPD subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and frequency of COPD exacerbations in each of the intervention groups
Measured: December 2008 to March 2009 inclusive
Electronic diary symptoms using the EXACT instrument
Measured: Daily recording
Secondary outcomes (3)
Medication usage and hospital admissions
Measured: Acutely
Changes in the St Georges Respiratory questionaire
Measured: Start and end of study period
Severity and duration of exacerbations assessed using the EXACT instrument
Measured: Daily recording
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2008 (estimated)
- Study startAug 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- David Halpin, MD, Principal investigator, Royal Devon and Exeter Hospital, Exeter, Devon, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00788645
- Sponsor's protocol ID
- D6256M00017
- Status last verified
- Nov 2010
- First submitted
- 10 Nov 2008
- Last updated
- 2 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21687919
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Forecasting System for Predicting Exacerbations of COPD: Effect on Symptoms and Hospitalisation and Relevance of Viral Infections
- ClinicalTrials.gov ID
- NCT00788645
- Acronym / sponsor ID
- D6256M00017
- Keywords
- Smoking, COPD, Chronic Obstructive Lung Disease, COPD Exacerbations, Viruses and Bacteria associated with COPD exacerbations
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 11 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Forecast | Experimental | Behavioral: COPD self care advice, Behavioral: Poor weather forecast warningCOPD patients receiving advice and poor weather warning |
| No Forecast | Experimental | Behavioral: COPD self care adviceCOPD patients receiving advice and poor weather warning |
| Control | No intervention | –Age matched non - COPD subjects |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Current or former smokers with a diagnosis of COPD
- Having impaired lung function as measured by spirometry
Key exclusion criteria (3 listed)
- History of asthma or nasal symptoms caused by hayfever
- No telephone
- Inability to record symptoms in an electronic diary (PDA)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COPD self care adviceInformation leaflets on COPD and thermometers to monitor the ambient temperature in the bedroom and living room | Behavioural | Forecast, No Forecast |
| Poor weather forecast warningInteractive automated telephone service to contact patients prior to anticipated periods of poor weather | Behavioural | Forecast |
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2010.
- Derived from this study: PubMed 21687919Halpin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Halpin, MD principal investigator
Royal Devon and Exeter Hospital, Exeter, Devon, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing COPD self care advice and Poor weather forecast warning in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and frequency of COPD exacerbations in each of the intervention groups (time frame: December 2008 to March 2009 inclusive). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00788645, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2010.