Severe Persistent AsthmaCSANNCT00954850
A National Program for Severe Asthma: The Canadian Severe Asthma Network
An observational study of Severe Persistent Asthma, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Persistent Asthma
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2010to Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Severe asthmatics as the primary study group, mild-moderate asthmatics as the control group
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
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.
We have been reviewing a few of the patients' biopsies for clues to how we can better manage them within clinical setting and note significant differences between individuals in relation to muscle mass, neuronal hypertrophy, and inflammation (which more often than not is absent in those with severe asthma).
Bronchoscopies are done routinely in SA patients to assess their airways better and obtain bronchoalveolar lavage (BAL) specimens and sometimes transbronchial biopsies.
Our hypotheses and/ or research questions are:
Immediate:
- Natural History:
- What is the natural history of SA?
- What proportion of patients with SA and MMA have had a prior NFA episode? (retrospective)
- Do deaths due to asthma occur more commonly in Canadians with SA, as opposed to those with MMA? (prospective)
- NFA and SA:
- What is the regional prevalence of NFA episodes in individuals with SA managed within a Canadian Health Care System?
- What is the natural history of patients with SA who have experienced an episode of NFA?
- Does management of SA within SA Centres of Excellence (SA Centres) alter the risk of subsequent episodes of NFA?
- What genes are related to NFA in individuals with SA and MMA?
- What is the burden of co-morbidities in individuals with SA as opposed to individuals with MMA?
- What is the burden of steroid-related complications in patients with SA?
- Immunology:
- What is the regional prevalence of atopy in SA?
- What is the regional prevalence of non-TH2 mediated immunologic deviances in SA? Future Projects once CSAN registry is established (with specific grant funding requests)
- Education:
- What are the unique educational needs of patients with SA that need to be resolved?
- Can we use the same translatable SA action plan in each SA Centre?
- Inflammatory monitoring:
- What are the barriers to implementing the use of sputum cell counts (SCCs) routinely within SA Centres in Canada from a cost-benefit perspective?
- What are the barriers to establishing a standard protocol for SCC monitoring (frequency every 3 months) in SA Centres?
- Is there a role for Exhaled Nitric Oxide (ENO) measurement over and above SCC monitoring in SA Centres for individuals with SA?
- Symptom perception:
- How does the perception of dyspnea vary in patients with NFA and those with SA?
- Are there simple ways to identify patients with poor perception of dyspnea in this high risk population?
- Pathophysiology:
- What factors promote fixed airflow obstruction in this population?
- What are the features that lead to persistent airway neutrophilia in this population?
- Do those with SA develop more airway remodelling than those with MMA and when present, does airway remodelling progress at a faster rate in the SA group?
- Health Service Delivery:
- Are there differences in organizational clinic structure of SA Centres that improve efficiency of management?
- Can we develop further specialized new SA Centres in Canada effectively (knowledge transfer for organization)?
- Is it cost effective to develop regional SA Centres in Canada?
- Conditions
- Severe Persistent Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Severe asthmatics | Main study group | |
| Mild-moderate asthmatics | Control group |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2009 (estimated)
- Study startJun 2010
- Primary completionAug 2012
- Study completionAug 2012
Why it stopped: Subjects not entered into electronic database due to current construct of database and associated privacy legislations within Alberta.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Persistent AsthmaStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilini Vethanayagam, University of Alberta
- Investigators
- Dilini Vethanayagam, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954850
- Sponsor's protocol ID
- CSAN Protocol
- Acronym
- CSAN
- Status last verified
- Aug 2012
- First submitted
- 5 Aug 2009
- Last updated
- 24 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National Program for Severe Asthma: The Canadian Severe Asthma Network
- ClinicalTrials.gov ID
- NCT00954850
- Acronym / sponsor ID
- CSAN / CSAN Protocol
- Conditions
- Severe Persistent Asthma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Subjects not entered into electronic database due to current construct of database and associated privacy legislations within Alberta.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 7 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
We have been reviewing a few of the patients' biopsies for clues to how we can better manage them within clinical setting and note significant differences between individuals in relation to muscle mass, neuronal hypertrophy, and inflammation (which more often than not is absent in those with severe asthma).
Bronchoscopies are done routinely in SA patients to assess their airways better and obtain bronchoalveolar lavage (BAL) specimens and sometimes transbronchial biopsies.
Our hypotheses and/ or research questions are:
Immediate:
- Natural History:
- What is the natural history of SA?
- What proportion of patients with SA and MMA have had a prior NFA episode? (retrospective)
- Do deaths due to asthma occur more commonly in Canadians with SA, as opposed to those with MMA? (prospective)
- NFA and SA:
- What is the regional prevalence of NFA episodes in individuals with SA managed within a Canadian Health Care System?
- What is the natural history of patients with SA who have experienced an episode of NFA?
- Does management of SA within SA Centres of Excellence (SA Centres) alter the risk of subsequent episodes of NFA?
- What genes are related to NFA in individuals with SA and MMA?
- What is the burden of co-morbidities in individuals with SA as opposed to individuals with MMA?
- What is the burden of steroid-related complications in patients with SA?
- Immunology:
- What is the regional prevalence of atopy in SA?
- What is the regional prevalence of non-TH2 mediated immunologic deviances in SA? Future Projects once CSAN registry is established (with specific grant funding requests)
- Education:
- What are the unique educational needs of patients with SA that need to be resolved?
- Can we use the same translatable SA action plan in each SA Centre?
- Inflammatory monitoring:
- What are the barriers to implementing the use of sputum cell counts (SCCs) routinely within SA Centres in Canada from a cost-benefit perspective?
- What are the barriers to establishing a standard protocol for SCC monitoring (frequency every 3 months) in SA Centres?
- Is there a role for Exhaled Nitric Oxide (ENO) measurement over and above SCC monitoring in SA Centres for individuals with SA?
- Symptom perception:
- How does the perception of dyspnea vary in patients with NFA and those with SA?
- Are there simple ways to identify patients with poor perception of dyspnea in this high risk population?
- Pathophysiology:
- What factors promote fixed airflow obstruction in this population?
- What are the features that lead to persistent airway neutrophilia in this population?
- Do those with SA develop more airway remodelling than those with MMA and when present, does airway remodelling progress at a faster rate in the SA group?
- Health Service Delivery:
- Are there differences in organizational clinic structure of SA Centres that improve efficiency of management?
- Can we develop further specialized new SA Centres in Canada effectively (knowledge transfer for organization)?
- Is it cost effective to develop regional SA Centres in Canada?
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Severe asthmatics | – | –Main study group |
| Mild-moderate asthmatics | – | –Control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Severe asthmatics as the primary study group, mild-moderate asthmatics as the control group
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2012.
- CSAN PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dilini Vethanayagam, MD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Persistent Asthma, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2012.