A National Program for Severe Asthma: The Canadian Severe Asthma Network (CSAN)

This study has been withdrawn prior to enrollment.
(Subjects not entered into electronic database due to current construct of database and associated privacy legislations within Alberta.)
Sponsor:
Information provided by (Responsible Party):
Dilini Vethanayagam, University of Alberta
ClinicalTrials.gov Identifier:
NCT00954850
First received: August 5, 2009
Last updated: August 23, 2012
Last verified: August 2012
  Purpose

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.


Condition
Severe Persistent Asthma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A National Program for Severe Asthma: The Canadian Severe Asthma Network

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Biospecimen Retention:   Samples Without DNA

If consented to by the patient, extra clinical specimens - sputum plugs, sputum supernatant, blood and urine will be stored. If patients undergo a clinical bronchoscopy, mucosal biopsies x 2 and bronchoalveolar lavage will be stored.


Enrollment: 0
Study Start Date: June 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Severe asthmatics
Main study group
Mild-moderate asthmatics
Control group

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Severe asthmatics as the primary study group, mild-moderate asthmatics as the control group

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00954850

Locations
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Dilini Vethanayagam, MD University of Alberta
  More Information

Additional Information:
No publications provided

Responsible Party: Dilini Vethanayagam, Associate Professor, Medicine (Pulmonary), University of Alberta
ClinicalTrials.gov Identifier: NCT00954850     History of Changes
Other Study ID Numbers: CSAN Protocol
Study First Received: August 5, 2009
Last Updated: August 23, 2012
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 26, 2014