From the FDA Drug Label
Formoterol Fumarate Inhalation Solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for: • Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
The role of Dulera (mometasone and formoterol) in the treatment of bronchitis is as a maintenance treatment for bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis.
- Key points:
- Long-term treatment
- Twice daily administration
- Maintenance treatment of bronchoconstriction
- For patients with COPD, including chronic bronchitis and emphysema 1
From the Research
Dulera is not typically recommended as a first-line treatment for acute bronchitis, and its use should be limited to patients with chronic bronchitis who have features of asthma (asthma-COPD overlap) as part of a comprehensive treatment plan by a healthcare provider. Acute bronchitis is usually viral in nature and self-limiting, requiring only symptomatic treatment such as rest, hydration, and over-the-counter pain relievers or cough suppressants. Antibiotics are generally not needed unless there is evidence of bacterial infection. Dulera, which contains mometasone (a corticosteroid) and formoterol (a long-acting beta-agonist), is primarily indicated for asthma maintenance therapy and not for acute bronchitis.
For chronic bronchitis, which is a form of COPD, treatment typically includes bronchodilators like albuterol, anticholinergics like ipratropium, and sometimes inhaled corticosteroids. The use of Dulera in COPD patients has been studied in several trials, including a 52-week Phase III trial that demonstrated significant improvements in lung function and respiratory health status with mometasone furoate/formoterol fumarate (MF/F) compared to placebo 2. Another study found that MF/F improved lung function, health status, and exacerbation rates in patients with moderate to very severe COPD 3. A more recent study published in 2021 found that regular treatment with formoterol and an inhaled corticosteroid versus regular treatment with salmeterol and an inhaled corticosteroid for chronic asthma did not show a significant difference in serious adverse events, including mortality and non-fatal serious adverse events 4.
Some key points to consider when using Dulera for bronchitis include:
- Dulera is not a first-line treatment for acute bronchitis
- Dulera may be used in patients with chronic bronchitis who have features of asthma (asthma-COPD overlap)
- Treatment of chronic bronchitis typically includes bronchodilators, anticholinergics, and sometimes inhaled corticosteroids
- Dulera has been shown to improve lung function and respiratory health status in patients with moderate to very severe COPD
- The use of Dulera should be part of a comprehensive treatment plan by a healthcare provider, and patients should be monitored for potential side effects and interactions with other medications.
Using Dulera inappropriately for bronchitis could mask symptoms without addressing the underlying cause and may expose patients to unnecessary medication side effects. If you're experiencing bronchitis symptoms, consult with a healthcare provider for proper diagnosis and treatment recommendations tailored to your specific condition.