Introduction

Chronic Obstructive Pulmonary Disease is a progressive respiratory disease-causing airflow obstruction and high global morbidity, with India reporting 37.8 million cases and significant mortality. Inhalation therapy, primarily bronchodilators, is the cornerstone of management, with inhaled corticosteroid (ICS) added for frequent exacerbations or high eosinophil counts. Budesonide/formoterol (ICS-long acting β-agonist) improves lung function, reduces exacerbations, and enhances quality of life. Device choice critically impacts adherence, especially in elderly patients prone to inhaler errors due to reduced dexterity and cognitive decline. Breath-actuated inhalers (BAIs), like Synchrobreathe®, overcome coordination challenges, require lower inspiratory effort, and show higher patient preference with fewer errors than pMDIs. Although real world evidence supports its usability, COPD specific data remain limited.

Aim

This study aimed to assess clinical outcomes and usability of budesonide/formoterol FDC delivered via Synchrobreathe^® in COPD patients.

Method

Study Design

Patient Inclusion Criteria 

• Patients of either sex, aged ≥40 years 
• Documented COPD diagnosis per GOLD 2020 guidelines 
• COPD assessment score (CAT) score ≥10 points
• Prescribed budesonide/formoterol FDC via Synchrobreathe^® for any of the following: 
  1. Inadequate control with current treatment
  2. On ICS/LABA but requiring addition of budesonide/formoterol FDC
  3. Unable to use or dissatisfied with previously prescribed inhaler

Treatment Strategy 

• This study was carried out across 23 sites in India from August 2021 to August 2022
• The clinical and safety outcomes were evaluated at baseline, week 4, 8 and 12
• Patients were administered two puffs of budesonide/formoterol (200/6 µg) FDC delivered through Synchrobreathe^® twice daily for 12 weeks or as per the investigator’s discretion, according to routine clinical practice

Endpoints

Primary Endpoint

Secondary Endpoints

• Changes in CAT score at week 4 and 8 from baseline
• Changes in modified Borg Dyspnea Scale (mBDS) score at week 4, 8 and 12 from baseline
• Device usability assessed using a device usability questionnaire at week 4

Safety Endpoint

Results

• Of the 250 enrolled patients, 243 completed the study
• Baseline characteristics of cohort were as follows
  1. Mean age 64.19+9.47 years; 78% men
  2. Mean COPD duration: 8.7+7.95 years; 
  3. 61.6% smokers
  4. Symptoms: cough, dyspnea, wheezing and sputum production
  5. Moderate/severe COPD prevalent in 51.2% and 41.2% respectively
  6. Hospitalization due to COPD exacerbation in 14%
  7. Mean CAT score at baseline 17.78+4.17
  8. Mean mBDS score ate baseline 4.21+1.54.
• There was a significant reduction in the CAT scores from baseline at week 4, 8 and 12; p<0.0001 as seen in Figure 1. 
• At week 4, minimal clinically important difference of 2 units in CAT score was observed 

 

Figure 1. CAT score at baseline, week 4, 8 and 12

 

Figure 2. COPD impact level

• The mBDS score also reduced significantly at week 4, 8 and 12 as compared to baseline; p<0.0001 as seen in Figure 3
• Minimal clinically important difference of 1 unit in mBDS score was noted at week 8 and 12, indicating improvement in COPD symptoms

 

Figure 3. mBDS score at baseline, week 4, 8 and 12

• About 98% of the patients preferred Synchrobreathe® over their previous inhalers
• About 94.35% found Synchrobreathe® easy to use, 98.79% were satisfied with the device and 96.78% were confident of using the device correctly
• A total of 37 non-serious AEs were reported by 11.2%, of these only 2 events, dry mouth and mouth ulcer were related to the drug
• There were no serious AEs and deaths reported  

Conclusion

• Synchrobreathe® inhaler delivering budesonide/formoterol FDC improved COPD control with significant CAT score reduction after 12 weeks
• Patients preferred its user-friendly design, rated it highly for usability, and reported no serious adverse events, confirming its safety and effectiveness for COPD management in India

Drugs Real World Outcomes. 2025 Dec;12(4):643-654. Doi: 10.1007/s40801-025-00522-w.