What is the preferred method of therapy for patients experiencing six episodes per week of asthma and two nighttime episodes per week, indicating poorly controlled asthma?

From the Guidelines

For patients experiencing six episodes of asthma per week and two nighttime episodes weekly, the preferred therapy is a low-dose inhaled corticosteroid (ICS) plus a long-acting beta-agonist (LABA) as controller medication, along with a short-acting beta-agonist (SABA) as needed for rescue. This recommendation is based on the most recent and highest quality evidence available, specifically from the study published in 2010 1. The guidelines suggest that for moderate persistent asthma, which is indicated by this frequency of symptoms, dual controller therapy with an ICS and a LABA is the preferred treatment approach.

Key Components of Therapy

• Low-dose ICS: Reduces airway inflammation, a key component in the pathophysiology of asthma.
• LABA: Provides bronchodilation and enhances the effectiveness of the ICS.
• SABA (e.g., albuterol): Used as needed for rescue to quickly relieve acute asthma symptoms.

Specific Treatment Options

• Fluticasone/salmeterol (Advair) 100/50 mcg twice daily
• Budesonide/formoterol (Symbicort) 80/4.5 mcg two inhalations twice daily
• Mometasone/formoterol (Dulera) 100/5 mcg two inhalations twice daily For rescue, albuterol 90 mcg 1-2 puffs every 4-6 hours as needed is recommended.

Patient Education and Follow-Up

Patients should be instructed on proper inhaler technique to ensure effective drug delivery and adherence to the treatment regimen. They should also be advised to rinse their mouth after ICS use to prevent thrush. Follow-up within 2-4 weeks is crucial to assess symptom control and adjust therapy as necessary. If symptoms persist, stepping up therapy to a medium-dose ICS/LABA or adding other controllers may be necessary, as suggested by guidelines and evidence from studies such as 1 and 1.

Considerations for Therapy Adjustment

The decision to adjust therapy should be based on the patient's response to the initial treatment, considering factors such as symptom control, lung function, and the occurrence of exacerbations. The guidelines emphasize the importance of a stepwise approach for managing asthma, adjusting treatment based on the level of asthma control and the risk of future exacerbations, as outlined in studies like 1 and 1.

From the FDA Drug Label

The efficacy of SINGULAIR for the chronic treatment of asthma in adults and adolescents 15 years of age and older was demonstrated in two (U. S. and Multinational) similarly designed, randomized, 12-week, double-blind, placebo-controlled trials in 1576 patients The patients studied were mild and moderate, non-smoking asthmatics who required approximately 5 puffs of inhaled β-agonist per day on an “as-needed” basis The patients had a mean baseline percent of predicted forced expiratory volume in 1 second (FEV1) of 66% (approximate range, 40 to 90%) The co-primary endpoints in these trials were FEV1 and daytime asthma symptoms Secondary endpoints included morning and evening peak expiratory flow rates (AM PEFR, PM PEFR), rescue β-agonist requirements, nocturnal awakening due to asthma, and other asthma-related outcomes In adult patients, SINGULAIR reduced “as-needed” β-agonist use by 26.1% from baseline compared with 4.6% for placebo In patients with nocturnal awakenings of at least 2 nights per week, SINGULAIR reduced the nocturnal awakenings by 34% from baseline, compared with 15% for placebo

The preferred method of therapy for patients experiencing six episodes per week of asthma and two nighttime episodes per week, indicating poorly controlled asthma, is not explicitly stated in the provided drug label. However, based on the information provided, montelukast (SINGULAIR) may be considered as a treatment option for patients with asthma, as it has been shown to reduce daytime asthma symptoms, nocturnal awakenings, and "as-needed" β-agonist use.

• Key benefits of montelukast include:
  • Reduction in "as-needed" β-agonist use
  • Reduction in nocturnal awakenings
  • Improvement in daytime asthma symptoms However, the optimal treatment approach for patients with poorly controlled asthma, experiencing six episodes per week of asthma and two nighttime episodes per week, may involve a combination of therapies, and the provided drug label does not provide sufficient information to determine the preferred method of therapy for this specific patient population 2.

From the Research

Asthma Treatment Options

The preferred method of therapy for patients experiencing six episodes per week of asthma and two nighttime episodes per week, indicating poorly controlled asthma, can be determined by analyzing various studies.

• A study published in 1997 3 compared the efficacy and safety of inhaled salmeterol and salbutamol in patients with mild-to-moderate asthma, finding that salmeterol was more effective in improving symptoms and lung function.
• Another study from 2003 4 reviewed the pharmacoeconomic use of salmeterol/fluticasone propionate combination in the management of asthma, concluding that it is a cost-effective treatment option for patients with asthma not controlled with inhaled corticosteroid therapy.
• A 2009 study 5 compared the use of healthcare services between new users of budesonide/formoterol and fluticasone/salmeterol, finding that users of budesonide/formoterol had better outcomes, including lower rates of emergency department visits and hospitalizations for asthma.
• More recent studies from 2021 6 and 7 explored the use of combination fixed-dose beta agonist and steroid inhalers as required for adults or children with mild asthma, and dual biologic therapy in patients with severe asthma and other allergic disorders, respectively.

Treatment Recommendations

Based on the evidence, the following treatment options can be considered:

• Salmeterol/fluticasone propionate combination therapy, as it has been shown to be effective in improving symptoms and lung function, and is a cost-effective treatment option 4.
• Budesonide/formoterol combination therapy, as it has been associated with better outcomes, including lower rates of emergency department visits and hospitalizations for asthma 5.
• Combination fixed-dose beta agonist and steroid inhalers as required, which have been shown to be effective in reducing exacerbations and improving asthma control in patients with mild asthma 6.
• Dual biologic therapy, which may be a useful steroid-sparing treatment option for patients with uncontrolled severe asthma and other allergic disorders 7.

Key Findings

Key findings from the studies include:

• Salmeterol was more effective than salbutamol in improving symptoms and lung function in patients with mild-to-moderate asthma 3.
• Salmeterol/fluticasone propionate combination therapy is a cost-effective treatment option for patients with asthma not controlled with inhaled corticosteroid therapy 4.
• Budesonide/formoterol combination therapy is associated with better outcomes, including lower rates of emergency department visits and hospitalizations for asthma 5.
• Combination fixed-dose beta agonist and steroid inhalers as required can reduce exacerbations and improve asthma control in patients with mild asthma 6.
• Dual biologic therapy may be a useful steroid-sparing treatment option for patients with uncontrolled severe asthma and other allergic disorders 7.