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Corticosteroid
A Study to Investigate the Differential Effects of Inhaled Symbicort and Advair on Lung Microbiota (DISARM Trial)
Phase 2
Waitlist Available
Led By Don Sin, MD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This study will evaluate the effects of budesonide (using Symbicort which is budesonide and formoterol) and fluticasone (using Advair which is fluticasone and salmeterol) on the airway microorganisms of patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). This is a randomized, parallel group, two-centered clinical trial study to evaluate the effects of a 12 week treatment with Symbicort 400 mcg BID and Advair 250 mcg BID (via Diskus) on airway microbiota in patients with moderate-to-severe COPD. The control arm of this study will be Oxeze 12 ug BID.
Eligible Conditions
- Chronic Obstructive Pulmonary Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Fluticasone groupExperimental Treatment1 Intervention
Advair (fluticasone) 250 mcg to be administered twice daily via Diskus for 12 weeks
Group II: Budesonide groupExperimental Treatment1 Intervention
Symbicort (budesonide) 400 mcg to be administered twice daily via Turbuhaler for 12 weeks
Group III: Formoterol groupActive Control1 Intervention
Oxeze (formoterol) 12 microg to be administered twice daily via Turbuhaler for 12 weeks
Find a Location
Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,481 Previous Clinical Trials
2,494,847 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,427 Previous Clinical Trials
289,164,383 Total Patients Enrolled
Don Sin, MDPrincipal InvestigatorSt. Paul's Hospital
2 Previous Clinical Trials
842 Total Patients Enrolled