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ISRCTN
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ISRCTN07043627
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ClinicalTrials.gov identifier
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Public title
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Risk of deep venous thrombosis and pulmonary embolism in severe asthma
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Scientific title
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Risk of deep venous thrombosis and pulmonary embolism in severe asthma: an observational study
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Acronym
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N/A
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Serial number at source
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Astmafonds 3.2.11.021
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Study hypothesis
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1. The prevalence of venous thromboembolism (VTE) is increased in patients with severe asthma as compared to the general population
2. The prevalence of VTE increases with severity of asthma
3. Use of corticosteroids is associated with increased prevalence of VTE in patients with asthma
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Lay summary
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Lay summary under review
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Ethics approval
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The questionnaire was qualified as no overburden for the patient. Therefore no Medical Ethics Committee approval was needed.
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Study design
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Open label observational cross-sectional study
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Asthma
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Participants - inclusion criteria
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1. Age 18-88 years old
2. Patients recruited from outpatient clinics from the Academic Medical Centre Amsterdam, Medical Center Leeuwarden and the Dutch High Altitude Asthma Clinic, Davos, Switzerland
3. Confirmed diagnosis of asthma according to Global Initiative for Asthma (GINA) 2010 guidelines
4. Diagnosis of severe asthma according to the international consensus 2009 (IMI-UBIOPRED)
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Participants - exclusion criteria
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1. Severe co-morbidities that could interfere with coagulation (Including cancer, other severe inflammatory diseases and human immunodeficiency virus (HIV)
2. Severe psychiatric illness
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Anticipated start date
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01/12/2010
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Anticipated end date
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01/05/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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550 (275 mild / moderate asthma and 275 severe asthma patients)
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Interventions
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All patients will complete a questionnaire about:
1. History of deep venous thrombosis (DVT) and pulmonary embolism (PE)
2. History of asthma
3. Medication use
The results of all included patients will be compared with a comparable reference general population (Naess IA, et al. J Thromb Haemost 2007 April;5(4):692-9). Because sex and age have a large influence on the incidence of DVT and pulmonary embolism (PE), the reference general population will be matched to sex and age for all patients. The study population will be compared with the reference general population by indirect standardisation.
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Primary outcome measure(s)
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Cumulative number of first DVT and PE events during lifetime as compared to the sum of the expected cumulative hazards of first DVT and PE events from all patients in an age- and sex-matched general population
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Secondary outcome measure(s)
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Hazard ratio for PE and DVT of of asthma associated factors (like oral and inhalational corticosteroids, atopy, duration of asthma, age of onset)
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Sources of funding
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Astmafonds (Netherlands) (ref: 3.2.11.021)
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Trial website
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Publications
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Contact name
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Mr
C
Majoor
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Address
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Meibergdreef 9
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City/town
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Amsterdam
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Zip/Postcode
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1105 AZ
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Country
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Netherlands
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Sponsor
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Astmafonds (Netherlands)
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Address
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Postbus 627
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City/town
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Amersfoort
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Zip/Postcode
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3800 AP
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Country
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Netherlands
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Sponsor website:
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http://www.astmafonds.nl/
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Date applied
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09/11/2011
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Last edited
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30/11/2011
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Date ISRCTN assigned
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30/11/2011
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