Introduction

An extrafine formulation of beclomethasone/formoterol fixed combination (BDP/F pMDI HFA) in pressurized metered dose inhaler (pMDI) is approved for both fixed maintenance and maintenance and reliever therapy (MART) of asthma. It has been proven that BDP/F pMDI HFA is effective in asthma control and well tolerated as other fixed inhaled corticosteroids/long-acting β-2 agonists (ICS/LABA) combinations.

Aim

To evaluate the level of asthma control in a real-life setting in adult patients using extrafine BDP/F pMDI HFA as maintenance as well as maintenance and reliever therapy (MART).

Method

Study Design

• Multicenter, prospective, non-interventional observational study

  Inclusion Criteria

• Patients aged >18 years old
• Having asthma for atleast 12 months and using BDP/F pMDI HFA as MART or BDP/F pMDI HFA as maintenance therapy and short-acting β2-agonist (SABA) as a reliever for atleast 2 months

Treatment Strategy

• Cohort was evaluated at 3 study time points: at baseline, 2 months and 4 months after enrollment

  Endpoints

• Degree of asthma control using the Asthma Control Questionnaire 7 (ACQ-7)
• Compliance using the Morisky Medication Adherence Scale (MMAS-4)

Results

• The study enrolled 2179 patients; 943 patients used BDP/F pMDI HFA as maintenance therapy and as-needed SABA and 1130 patients used BDP/F pMDI HFA as both maintenance and reliever therapy
• The daily mean actual dose for BDP/F pMDI HFA as maintenance therapy was 4Is and for both maintenance/reliever therapy was 2
• Notable increase in FEV₁% (forced expiratory volume in 1 s) was seen at subsequent visits
• Asthma control improved significantly as indicated by a decline in the mean ACQ-7 score; p < 0.001

  Figure 1. ACQ-7 score at subsequent follow-up visits

  

• Proportion of patients with good asthma control increased over the follow-up period

  Figure 2. % of patients with good asthma control

  

• Majority of patients preferred pMDI vs DPI (dry powder inhaler); 91.5% vs 3.2%, p<0.001
• An increase in patients' compliance was also noted. The number of patients that reported forgetting at times to take their medication was reduced from 49.7 % to 27.1 %, p < 0.001
• Reduction in the number of as-needed doses used for symptom relief was also demonstrated; p < 0.001

Conclusion

• Extrafine beclomethasone/formoterol fixed combination (BDP/F pMDI HFA) in pressurized metered dose inhaler (pMDI) used as maintenance as well as reliever therapy was associated with increased asthma control and better patient compliance.

Pulm Pharmacol Ther. 2024 Mar: 84:102272. Doi: 10.1016/j.pupt.2023.102272.