SYMBICORT for your asthma patients ≥12 years of age uncontrolled on an ICS or whose disease severity clearly warrants an ICS/LABA

Patient profile

SYMBICORT for your asthma patients ≥12 years of age uncontrolled on an ICS or whose disease severity clearly warrants an ICS/LABA

Patient profile

Treatment initiation

NAEPP/NHLBI recommends initiating an ICS/LABA§ for patients whose disease severity clearly warrants it1

  • Symptomatic daily
  • Requiring SABA|| use daily
  • Awakening at night due to symptoms >1x per week
  • Experiencing some activity limitation
  • National Asthma Education and Prevention Program/National Heart, Lung, and Blood Institute.
  • Inhaled corticosteroid.
  • §Long-acting beta2-adrenergic agonist.
  • ||Short-acting beta2-adrenergic agonist.

Shawna’s Profile

Meet Shawna, an asthma patient

Here is an example of a patient, representative of a patient studied in the SYMBICORT higher-dose asthma pivotal study by Noonan et al:

Shawna—27-year-old yoga instructor

Frustrated with how her asthma symptoms have become an increasingly frequent interruption throughout the day and night.

History

  • Diagnosed with moderate-persistent asthma
  • FEV1=75% predicted normal

Current visit

  • Asthma symptoms include cough, chest tightness, and shortness of breath
    • Symptom control has decreased over the past year
  • Uses SABA >1 times/day
  • Awakens at night due to symptoms 2 times/week
  • Starting to limit activities because of her asthma
  • Hypothetical patient case.
  • Short-acting beta2-adrenergic agonist.

Treatment initiation

Noonan Study overview

The Noonan Study patients included those uncontrolled on an ICS2

  • Patients with moderate to severe asthma (received moderate- to high-dose ICSs, either alone or in combination with other asthma control medication at entry)
    • 72% moderate
    • 28% severe
  • Symptomatic
  • Using rescue albuterol
  • ≥12 years of age
 

Shawna’s Profile

Study Designs

The efficacy and safety of SYMBICORT was evaluated in 2 pivotal studies2,3

Study 1

A 12-week, double-blind, placebo-controlled study comparing SYMBICORT 160/4.5 mcg, budesonide 160 mcg, formoterol 4.5 mcg, the free combination of budesonide 160 mcg plus formoterol 4.5 mcg in separate inhalers, and placebo, each administered as 2 inhalations twice daily. A total of 596 patients (124 randomized to receive SYMBICORT) ≥12 years of age were evaluated. The study included a 2-week run-in period with budesonide 80 mcg, 2 inhalations twice daily. Most patients had moderate to severe asthma and were using moderate to high doses of inhaled corticosteroids (ICSs) prior to study entry. This study was designed to assess 2 primary endpoints. The first was predose FEV1 averaged over 12 weeks, and the second was 12-hour average postdose FEV1 at week 2. Secondary efficacy variables included daytime and nighttime asthma symptom scores and daily rescue medication use (both recorded by patients in the electronic diary).

Study 2

A 12-week, randomized, multicenter, double-blind, double-dummy, placebo-controlled study comparing SYMBICORT 80/4.5 mcg, budesonide 80 mcg, formoterol 4.5 mcg, each administered as 2 inhalations twice daily. A total of 480 patients (123 randomized to receive SYMBICORT) ≥12 years of age were evaluated. The study included a 2-week run-in period with placebo and rescue albuterol therapy. Most patients had mild to moderate persistent asthma and were using low to moderate doses of ICS either alone or as part of combination therapy prior to study entry. This study was designed to assess 2 primary endpoints. The first was predose FEV1 averaged over 12 weeks, and the second was 12-hour average postdose FEV1 at Week 2. Secondary efficacy variables included daytime and nighttime asthma symptom scores and daily rescue medication use (both recorded by patients in the electronic diary).

*Subject to eligibility rules; restrictions apply.