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

NCT00954850 | Withdrawn

• 1 other identifier: CSAN Protocol
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Severe Persistent Asthma

Study Arms (2)

Severe asthmatics

Main study group

Mild-moderate asthmatics

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Links

• CSAN Page

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.

Study Officials

• Dilini Vethanayagam, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Medicine (Pulmonary)

Study Record Dates

• First Submitted: August 5, 2009
• First Posted: August 7, 2009
• Study Start: June 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 24, 2012

Record last verified: 2012-08

Locations

CA (1)