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Corticosteroid

Fluticasone group for Chronic Obstructive Pulmonary Disease (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 12 weeks
Awards & highlights

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 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in bacterial diversity using Shannon Index based on 16S sequencing.
Change in total bacterial population in the bronchoalveolar lavage fluid
Secondary outcome measures
Change in St. George's Respiratory Questionnaire
Change in bacterial membership using Beta-diversity
Change in forced expiratory volume in 1 second
+6 more

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
1,431 Previous Clinical Trials
2,478,834 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,302 Previous Clinical Trials
288,624,530 Total Patients Enrolled
Don Sin, MDPrincipal InvestigatorSt. Paul's Hospital
2 Previous Clinical Trials
842 Total Patients Enrolled
~7 spots leftby Sep 2025
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