Condition category
Respiratory
Date applied
09/11/2011
Date assigned
30/11/2011
Last edited
29/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Asthma is one of the most common long-term lung diseases. Most asthma can be controlled with inhaled corticosteroids and bronchodilators. Venous thromboembolism (VTE) is a serious, potentially fatal, condition where a blood clot forms in a vein. The aim of the study is to find out whether the risk of venous thromboembolism is increased in severe asthma and whether this is related to asthma severity and the use of corticosteroids.

Who can participate?
Patients aged over 18 with asthma.

What does the study involve?
The patients are asked to complete a questionnaire about their history of VTE, history of asthma and medication use. The results are then compared with a comparable reference general population. Because sex and age have a large influence on the incidence of VTE, the reference general population is matched by sex and age.

What are the possible benefits and risks of participating?
There are no known risks to participants.

Where is the study run from?
Academic Medical Centre, Amsterdam, The Netherlands
Medical Centre Leeuwarden, Leeuwarden, The Netherlands
Dutch high altitude Asthma Centre Davos, Switzerland
The study is coordinated by the Academic Medical Centre Amsterdam

When is the study starting and how long is it expected to run for?
December 2010 to May 2011

Who is funding the study?
Dutch Asthma Foundation

Who is the main contact?
Mr C.J. Majoor
c.j.majoor@amc.uva.nl

Trial website

Contact information

Type

Scientific

Primary contact

Mr C Majoor

ORCID ID

Contact details

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Astmafonds 3.2.11.021

Study information

Scientific title

Risk of deep venous thrombosis and pulmonary embolism in severe asthma: an observational study

Acronym

Study hypothesis

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

Ethics approval

The questionnaire was qualified as no overburden for the patient. Therefore no Medical Ethics Committee approval was needed.

Study design

Open label observational cross-sectional study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Asthma

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

Secondary outcome measures

Hazard ratio for PE and DVT of of asthma associated factors (like oral and inhalational corticosteroids, atopy, duration of asthma, age of onset)

Overall trial start date

01/12/2010

Overall trial end date

01/05/2011

Reason abandoned

Eligibility

Participant inclusion criteria

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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

550 (275 mild/moderate asthma and 275 severe asthma patients)

Participant exclusion criteria

1. Severe co-morbidities that could interfere with coagulation (Including cancer, other severe inflammatory diseases and human immunodeficiency virus (HIV)
2. Severe psychiatric illness

Recruitment start date

01/12/2010

Recruitment end date

01/05/2011

Locations

Countries of recruitment

Netherlands

Trial participating centre

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Astmafonds (Netherlands)

Sponsor details

Postbus 627
Amersfoort
3800 AP
Netherlands

Sponsor type

Research organisation

Website

http://www.astmafonds.nl/

Funders

Funder type

Research organisation

Funder name

Astmafonds (Netherlands) (ref: 3.2.11.021)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes