AsthmaNCT01525381
Strategies to Improve Asthma and Treatment of Asthma in Canadians
An observational study of Asthma, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
Our study will enroll 644 randomly-selected Canadians who have been diagnosed with asthma by a physician within the previous five years. It will be determined what diagnostic tests were initially performed to make this diagnosis. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Asthma
- How many people
- 701 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2011to Mar 2016
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Canadians diagnosed with Asthma and 18 years of age and older.
Who may be able to join
- Patient must have a recent diagnosis of asthma by a physician. Diagnosis of asthma must have occurred within 5 years prior to entry into the study.
- Patient must be at least 18 years old.
Who cannot join
- Patients in whom methacholine challenge is contraindicated
- Patients using chronic oral prednisone.
- Patients with heart attack or stroke within three previous months, and those with known aortic or cerebral aneurysms.
- Pregnant patients (unknown effect of methacholine on the fetus) and breastfeeding patients (unknown whether methacholine is excreted in breast milk).
- Patients unable to provide informed consent.
- Patients not able to perform spirometry and/or methacholine challenge testing.
Show all 10Show fewer
- Patients who have a greater than 10 pack-year smoking history (this will exclude patients with possible COPD).
- Patients who currently have active pulmonary Tuberculosis
- Patients who have had eye surgery in the past 3 months or who have a detached retina
- Patients involved in another interventional asthma study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Strategies to Improve Diagnosis and Treatment of Asthma in Canadians
Our study will enroll 644 randomly-selected Canadians who have been diagnosed with asthma by a physician within the previous five years. It will be determined what diagnostic tests were initially performed to make this diagnosis. Participants will undergo lung function testing over 6-8 weeks to determine their respiratory status and to confirm they have asthma. Participants may be followed up to one year depending on their test results.
- Conditions
- Asthma
- Medical subject headings
- Asthma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2012 (estimated)
- Study startNov 2011
- Primary completionApr 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 701 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shawn Aaron, MD, Principal investigator, Ottawa Hosptial Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01525381
- Sponsor's protocol ID
- 2011-221
- Status last verified
- Mar 2016
- First submitted
- 31 Jan 2012
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies to Improve Diagnosis and Treatment of Asthma in Canadians
- ClinicalTrials.gov ID
- NCT01525381
- Acronym / sponsor ID
- 2011-221
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 701 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 2 Feb 2012 (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.
Our study will enroll 644 randomly-selected Canadians who have been diagnosed with asthma by a physician within the previous five years. It will be determined what diagnostic tests were initially performed to make this diagnosis. Participants will undergo lung function testing over 6-8 weeks to determine their respiratory status and to confirm they have asthma. Participants may be followed up to one year depending on their test results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Canadians diagnosed with Asthma and 18 years of age and older.
Key inclusion criteria (2 listed)
- Patient must have a recent diagnosis of asthma by a physician. Diagnosis of asthma must have occurred within 5 years prior to entry into the study.
- Patient must be at least 18 years old.
Key exclusion criteria (10 listed)
- Patients in whom methacholine challenge is contraindicated
- Patients unable to provide informed consent.
- Patients not able to perform spirometry and/or methacholine challenge testing.
- Patients who have a greater than 10 pack-year smoking history (this will exclude patients with possible COPD).
- Patients who currently have active pulmonary Tuberculosis
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
Shawn Aaron, MD principal investigator
Ottawa Hosptial Research Institute
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 Asthma, run by Ottawa Hospital Research Institute 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 2 inclusion and 10 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: finished, as of the sponsor's last update on 31 Mar 2016. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 31 Mar 2016.