A Study to Investigate the Differential Effects of Inhaled Symbicort and Advair on Lung Microbiota (DISARM)

NCT02833480 Phase 2 UNKNOWN

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.

Details

Lead sponsor	University of British Columbia
Phase	Phase 2
Status	UNKNOWN
Enrolment	69
Start date	2015-02
Completion	2021-06

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

• Fluticasone group
• Budesonide group
• Formoterol group

Primary outcomes

• Change in total bacterial population in the bronchoalveolar lavage fluid — 12 weeks
• Change in bacterial diversity using Shannon Index based on 16S sequencing. — 12 weeks

Countries

Canada