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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title: A Study to Investigate the Differential Effects of Inhaled Symbicort and Advair on Lung Microbiota

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This is a randomized, non-placebo controlled study to evaluate the effects of Symbicort 400 mcg twice daily (BID) and Advair 250 mcg BID over 12 weeks. As the standard of therapy for COPD is a long-acting muscarinic antagonist (LAMA) treatment, a placebo only group cannot be ethically justified. The control arm of this study will thus be Oxeze 12 ug BID. The study will recruit approximately 69 subjects, from St. Paul's Hospital and British Columbia Cancer Agency, randomized 1:1:1 to the 3 arms in blocks. We anticipate 10 to 15% drop out rate, which will enable approximately 60 subjects for full analysis.

After the initial enrolment and confirmation of the entry criteria, subjects will perform spirometry before and following bronchodilation with salbutamol (up to 400 ug). They will then enter a 4-week run-in period during which all subjects will be withdrawn from inhaled corticosteroid containing products. They will then be treated with formoterol via Turbuhaler 12 ug BID and short-acting beta-2 agonists as needed (PRN). Subjects may also have LAMA (either tiotropium 18 ug once daily or glycopyrronium 50 ug once daily) at the discretion of the attending physician. At the end of the run-in phase, eligibility will be confirmed and then subjects will undergo pre and post-spirometry, low-dose thoracic computed tomography (CT) and bronchoscopy. One week post-bronchoscopy, the subjects will be randomized to a 12-week treatment period. Subjects may also have LAMA at the discretion of the attending physician. At the end of the 12 week treatment period, the subjects will undergo pre- and post-spirometry and 2nd bronchoscopy. The subjects will be re-evaluated one week following bronchoscopy and then discharged from the study. All subjects with pulmonary nodule requiring follow-up will be evaluated by the attending physician and the pulmonary nodule will be investigated as per guidelines of the Fleischner Society. ;

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

• NCT number: NCT02833480
• Study type: Interventional
• Source: University of British Columbia
• Contact: Lynda Lazosky
• Phone: 604-682-2344
• Email: llazosky@providencehealth.bc.ca
• Status: Recruiting
• Phase: Phase 2
• Start date: February 2015
• Completion date: June 2021