Background-Breath actuated inhalers (BAIs) such as Synchrobreathe^® are increasingly being used in clinical practice since they overcome coordination issue. Limited published data exists on efficacy and safety with BAIs in COPD patients.

Aim-To evaluate the effectiveness and safety of formoterol/budesonide through BAI in COPD patients.

Methods:This open-label, prospective, real-world study enrolled patients from outpatient clinics in India, who had a documented COPD diagnosis and were symptomatic on existing therapy (CAT score>10) or unable to use/dissatisfied with current inhaler and hence prescribed formoterol/budesonide (6/200mcg) (Foracort^®) through Synchrobreathe^®. Mean change in CAT (primary endpoint) and modified Borg Dyspnea Scale (MBDS) scores were assessed over 12 weeks and device usability at 4 weeks.

Results:The study enrolled 250 patients (mean age 64.1±9.47 years;78% males;92.8% moderate-severe COPD as per GOLD; 61.6% smokers;34% patients with exacerbation in previous year);7 patients discontinued the study. 52.4% patients were currently taking DPIs and 44% pMDIs. The CAT score significantly (p <0.001) decreased from 17.78±4.17 at baseline to 11.20±4.93 units at 12 weeks (mean reduction 6.56 units); decrease was significant from week 4. The MBDS score significantly (p<0.001) reduced from 4.21± 1.54 at baseline to 2.63±1.29 units at week 12. A total of 37 adverse events were reported; two were COPD exacerbations but did not need hospitalization. 94% patients found Synchrobreathe^® easy to use, 99% were satisfied and 98% preferred it over their previous inhaler.

Conclusion:Formoterol/budesonide delivered through Synchrobreathe^® is effective, safe and preferred by most COPD patients.