Strategies to Improve Asthma

Asthma Clinical Trial

Official title:

Strategies to Improve Diagnosis and Treatment of Asthma in Canadians

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01525381
• Other study ID #: 2011-221
• Status: Recruiting
• Phase: N/A
• First received: January 31, 2012
• Last updated: May 16, 2012
• Start date: November 2011
• Est. completion date: January 2015

Study information

• Verified date: May 2012
• Source: Ottawa Hospital Research Institute
• Contact: Shawn Aaron, MD
• Phone: 613-737-8899
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 644
• Est. completion date: January 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. Patient must be at least 18 years old.

Exclusion Criteria:

1. 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).

2. Patients unable to provide informed consent.

3. Patients not able to perform spirometry and/or methacholine challenge testing.

4. Patients who have a greater than 10 pack-year smoking history (this will exclude patients with possible COPD).

5. Patients who currently have active pulmonary Tuberculosis

6. Patients who have had eye surgery in the past 3 months or who have a detached retina

7. Patients involved in another interventional asthma study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
Canada	Ottawa Hospital	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada,