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临床试验/NCT00954850
NCT00954850撤回不适用

A National Program for Severe Asthma: The Canadian Severe Asthma Network

University of Alberta1 个研究点 分布在 1 个国家开始时间: 2010年6月最近更新:
适应症

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不适用
状态
撤回
试验地点
1

研究概览

简要总结

The Canadian Severe Asthma Network (CSAN) was developed to gain a better understanding of the clinical, environmental, socio-economic, work-related, and biological characteristics of severe asthmatics (SA) that may account for poor response to clinically available therapies for asthma.

This network of clinical and basic researchers will be a means by which Canadian investigators can develop and conduct research in this small patient group, which could lead to better clinical management of SA.

Patient information will be entered into the CSAN database (created by PI Dr. Vethanayagam in connection with Mr. Jack Yeung) and will help researchers and doctors from multiple hospitals and universities across Canada to understand this subpopulation of asthmatics better. It will help to answer questions regarding SA epidemiology, asthma education, inflammatory monitoring, risks of near fatal asthma (NFA), symptom perception, changes in lung structure and function, co-morbidities, and the effectiveness of developing regional severe asthma clinics. Two of the early projects the investigators will be working on are psychosocial co-morbidities in asthma and medication coverage related to asthma.

There will also be biobanking of sputum samples and/or bronchoscopy samples (such as BALs & lung washings) that are being obtained for clinical purposes. Also, for those consented for biobanking blood and urine will be collected, separate from clinical care, and stored in the biobank. The Canadian Biosample Repository (CBSR) will be storing our biobanked samples. The investigators will be following the CBSR policies for storage and security. Tissue research will be conducted in the future, and separate ethics approval will be obtained for each project.

详细描述

5-10% of adult asthmatics have difficult to control asthma or severe asthma (SA), some of whom require systemic steroids to control their disease ("steroid dependent asthmatics"). Very little is understood about this population (Chanez, et al. JACI June 07)

Networks to study severe asthma have emerged in Europe (ENFUMOSA) and the United States (US Severe Asthma Research Program) to understand this small group of patients who account for the majority of costs related to asthma care (>50%). We would like to establish a network in Canada of well characterized asthmatics with severe asthma (and mild-moderate asthmatics as controls).

Sputum cell counts assist somewhat in improving asthma management in this population but outside of eosinophilic inflammation (one subtype) do not predict asthma control (Lemiere C et al. J Allergy Clin Immunol 2006;118:1033-9).

Little is understood regarding the many patients who do not have frequent exacerbations but rather have chronic persistent asthma (symptoms multiple times a day) particularly when non-eosinophilic. SCCs are not as useful within this group and more detailed analysis of sputum (particularly supernatant) and more invasive testing is required as we see more of this population, to better treat them.

Even less is understood about severe asthma in childhood.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (18 and older) with physiologically confirmed SA or mild-moderate asthma and followed by an asthma specialist for at least 6 months.
  • Must agree to have regular clinic visits (minimum 3-4 per year for SA, 1-2 for mild-moderate asthma).
  • Must have good compliance with medications Patients with asthma and COPD.

排除标准

  • Malignancy and other significant medical conditions that will impact follow up within this program.
  • Those less than 18 years of age.
  • Concomitant interstitial lung disease, sarcoidosis, other significant lung disease.
  • Those who have had a transplant.
  • Significant travel with work.
  • Unable to make appointments (every three to six months over 2 years).
  • Those residing in another country or planned absence for more than one month.

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dilini Vethanayagam

Associate Professor, Medicine (Pulmonary)

University of Alberta

研究点 (1)

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