From the Guidelines
Dulera is a recommended prescription inhaler medication for asthma management in patients 5 years and older, combining mometasone furoate and formoterol fumarate to reduce inflammation and relax airway muscles. According to the guidelines for the diagnosis and management of asthma 1, long-acting beta2-agonists (LABAs) like formoterol are used in combination with inhaled corticosteroids (ICSs) like mometasone for long-term control and prevention of symptoms in moderate or severe persistent asthma. The medication is typically prescribed as 2 inhalations twice daily, available in two strengths: 100/5 mcg or 200/5 mcg per actuation. It's essential to rinse the mouth after use to prevent thrush, and Dulera is not intended for acute asthma attacks—a rescue inhaler should be used for sudden symptoms. This medication works by combining anti-inflammatory effects with bronchodilation for better asthma control, as outlined in the expert panel report 3 (EPR-3) guidelines 1. Side effects may include throat irritation, headache, and oral thrush. Patients should not stop using Dulera suddenly without medical guidance, as symptoms may worsen, and the inhaler should be primed before first use and if not used for more than 5 days by spraying 4 test sprays. The use of LABAs like formoterol in combination with ICSs like mometasone is supported by recent guidelines, which emphasize the importance of daily anti-inflammatory treatment with ICSs as the cornerstone of therapy for patients with persistent asthma 1.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Dulera Inhaler Overview
- The Dulera inhaler is a combination medication containing mometasone and formoterol, used for the maintenance treatment of asthma and chronic obstructive pulmonary disease (COPD) [no relevant studies provided].
- However, studies have investigated the efficacy of budesonide and formoterol as maintenance and reliever therapy for asthma control, which may be relevant to the Dulera inhaler.
Budesonide and Formoterol as Maintenance and Reliever Therapy
- A study published in 2016 compared the early effects of budesonide/formoterol with fluticasone furoate/vilanterol for asthma patients requiring step-up from inhaled corticosteroid monotherapy, and found that the budesonide/formoterol group showed significant improvement in FeNO, IOS parameters, and ACQ5 score at 4 weeks 2.
- Another study published in 2004 reviewed the use of budesonide/formoterol in asthma, and found that it was an effective and well-tolerated treatment option for patients with persistent asthma symptoms despite treatment with inhaled corticosteroids 3.
- A 2013 Cochrane review compared the efficacy and safety of budesonide and formoterol in a single inhaler for maintenance and reliever therapy in asthma, and found that single inhaler therapy reduced exacerbations requiring oral corticosteroids and improved symptom control 4.
- A 2024 observational study compared budesonide/formoterol with fluticasone furoate/vilanterol as maintenance and reliever therapy for asthma control, and found that both treatments showed similar effectiveness in improving asthma control 5.
- A 2022 systematic review and meta-analysis evaluated the use of budesonide-formoterol for maintenance and reliever therapy among patients with poorly controlled asthma, and found that switching to this treatment was associated with a longer time to first severe asthma exacerbation compared with other treatments 6.
Key Findings
- Budesonide and formoterol as maintenance and reliever therapy may be an effective treatment option for asthma control.
- The combination of budesonide and formoterol in a single inhaler may reduce exacerbations requiring oral corticosteroids and improve symptom control.
- Further studies are needed to fully understand the efficacy and safety of this treatment option.