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Improved lung function with beclomethasone/formoterol versus beclomethasone alone in asthma: the FORCE2 study
Steven Weinstein1, Lorenzo Legramandi2, Kusum Mathews2
1Allergy and Asthma Specialists Medical Group, Huntington Beach, CA, USA.
The combination of beclomethasone dipropionate (BDP) plus formoterol fumarate (FF) significantly improved lung function in asthma patients compared to BDP alone. Both inhaled therapies were found to be safe and well-tolerated.
Area of Science:
- Pulmonology
- Pharmacology
- Clinical Trials
Background:
- Asthma management relies on inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA).
- Fixed-dose combinations offer convenience and potentially improved adherence.
- Beclomethasone dipropionate (BDP) is an ICS, and formoterol fumarate (FF) is a LABA.
Purpose of the Study:
- To evaluate the efficacy of an inhaled BDP/FF combination versus BDP alone in asthma patients.
- To confirm the safety and tolerability profile of the BDP/FF combination.
Main Methods:
- A 12-week randomized controlled trial involving 576 asthma patients.
- Patients received either BDP/FF or BDP via a pressurized metered-dose inhaler (pMDI).
- Primary endpoint: change in FEV1 area under the curve (AUC0-12h); Secondary endpoint: peak FEV1 within 3 hours post-dose.
Main Results:
- The BDP/FF group showed statistically significant improvements in FEV1 AUC0-12h and peak FEV1 compared to the BDP group.
- Adjusted mean differences favored BDP/FF by 104 mL and 124 mL, respectively (p < 0.001).
- Adverse event rates were similar between groups (26.9% vs. 26.4%), with most events being mild to moderate.
Conclusions:
- The addition of formoterol fumarate (FF) to beclomethasone dipropionate (BDP) enhances lung function in asthma patients.
- The BDP/FF combination therapy is effective and well-tolerated, similar to BDP monotherapy.
- This study confirms the benefit of combining ICS and LABA for asthma control.
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