Efficacy

For asthma patients ≥12 years of age uncontrolled on an ICS or whose disease severity warrants an ICS/LABA

SYMBICORT provided sustained* control all-day and all-night2,3,4

  • 9% improvement in baseline lung function4,†
  • 87%‡ of mean peak lung function achieved within 15 minutes§ postdose3

SYMBICORT controlled both daytime and nighttime asthma symptoms5

  • SYMBICORT is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms
  • SYMBICORT is dosed twice daily. See Dosing for complete information
Efficacy of Asthma 2 3 2 2 3 3 4

Comparator Arms

Mean percent improvement in predose FEV1 at end of treatment (end of week 12, LOCF)

SYMBICORT 160/4.5 mcg: 9.4%
Budesonide: 4.9%
Formoterol: -4.8%
Placebo: -6.9%

Mean percent Improvement in postdose FEV1 in 15 minutes
Day of randomization

SYMBICORT 160/4.5 mcg: 15.8%
Budesonide: 2.4%
Formoterol: 16.9%
Formoterol/Budesonide: 16.3%
Placebo: 2.1%



End of treatment

SYMBICORT 160/4.5 mcg: 18.1%
Budesonide: 6%
Formoterol: 8.5%
Formoterol/Budesonide: 17%
Placebo: -3%


Study Data

Study 1: A 12-week efficacy and safety study

A 12-week, double-blind, placebo-controlled study comparing SYMBICORT 160/4.5 mcg, budesonide (BUD) 160 mcg, formoterol (FM) 4.5 mcg, the free combination of BUD 160 mcg plus FM 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 prior to study entry. This study was designed to assess 2 primary end points. The first was predose FEV1 averaged over 12 weeks, and the second was 12-hour average postdose FEV1 at day of randomization, week 2, and at end of trial. Secondary efficacy variables included morning and evening peak expiratory flow (PEF), daytime and nighttime symptom scores, nighttime awakenings as a result of asthma, daily rescue medication use (all recorded by patients in the electronic diary) and predefined criteria for worsening asthma.

  • *Sustained improvement in lung function was demonstrated in a 12-week efficacy and safety study.
  • †As measured by predose forced expiratory volume in 1 second (FEV1 )
  • ‡78.21% of observed mean peak effect was achieved within 15 minutes postdose at day of randomization; 87.43% at end of treatment.
  • §SYMBICORT improved lung function within 15 minutes (median time to >15% improvement in FEV1)and was maintained over the 12-hour dosing cycle.

SYMBICORT controlled both daytime and nighttime asthma symptoms5

1 1

Study 2: A 12-week efficacy and safety study

A 12-week, double-blind, placebo-controlled study comparing SYMBICORT 80/4.5 mcg, budesonide (BUD) 80 mcg, formoterol (FM) 4.5 mcg, and placebo, each administered as 2 inhalations twice daily. A total of 480 patients 12 years of age and older were evaluated. The study included a 2-week placebo run-in period. Most patients had mild to moderate asthma and were using low to moderate doses of inhaled corticosteroids prior to study entry. Mean number of albuterol inhalations per day at baseline for the groups receiving SYMBICORT and BUD were 2.75 and 2.99, respectively. This study was designed to assess 2 primary end points. The first was predose FEV1 averaged over 12 weeks, and the second was 12-hour average postdose FEV1 at day of randomization, week 2, and at end of trial. Secondary efficacy variables included morning and evening PEF, daytime and nighttime symptom scores, nighttime awakenings as a result of asthma, daily rescue medication use (all recorded by patients in the electronic diary) and predefined criteria for worsening asthma.

Placebo Comparison

Absolute mean reduction in symptom scores over 12 weeks for placebo

  • Daytime symptoms: 0.07
  • Nighttime symptoms: 0.11

Symptom Scoring

Daytime asthma symptom scores were recorded daily in the evening, and nighttime symptom scores for the previous night were recorded upon arising each morning. Symptom scores were rated on a scale of 0 to 3.

  • 0=None; no symptoms of asthma
  • 1=Mild symptoms; awareness of asthma symptoms and/or signs that are easily tolerated
  • 2=Moderate symptoms; asthma symptoms with some discomfort, causing some interference with daily activities or sleep
  • 3=Severe symptoms; incapacitating asthma symptoms and/or signs, with inability to perform daily activities or to sleep

SYMBICORT significantly reduced the need for rescue medication—helping patients breathe better6

Forced Expiratory Volume

1

Study 2: A 12-week efficacy and safety study

SYMBICORT is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms

  • Pressurized metered-dose inhaler

Updated Important Safety Information, including boxed WARNING

  • WARNING: Long-acting beta2-adrenergic agonists (LABA), such as formoterol, one of the active ingredients in SYMBICORT, increase the risk of asthma-related death. A placebo-controlled study with another LABA (salmeterol) showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including formoterol. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients
  • When treating patients with asthma, prescribe SYMBICORT only for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (eg, discontinue SYMBICORT) if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use SYMBICORT for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids

SYMBICORT is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms

It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may occur, particularly at higher doses. Particular care is needed for patients who are transferred from systemically active corticosteroids to inhaled corticosteroids. Deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids.

Patients who are receiving SYMBICORT should not use additional formoterol or other LABA for any reason.

Due to possible immunosuppression, potential worsening of infections could occur; a more serious course of chickenpox or measles can occur in susceptible patients.

Excessive beta-adrenergic stimulation has been associated with central nervous system and cardiovascular effects. SYMBICORT, like all products containing sympathomimetic amines, should be used with caution in patients with convulsive disorders, thyrotoxicosis, and cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Beta-adrenergic agonist medications may produce hypokalemia and hyperglycemia in some patients. As with other inhaled medications, paradoxical bronchospasm may occur with SYMBICORT. Use with caution in patients with diabetes mellitus.

Long-term use of orally inhaled corticosteroids, such as budesonide, a component of SYMBICORT, may result in a reduction in growth velocity and/or a loss of bone mineral density.

Glaucoma, increased intraocular pressure, and cataracts have been reported following the inhaled administration of corticosteroids, including budesonide, a component of SYMBICORT.

In rare cases, patients on inhaled corticosteroids may present with systemic eosinophilic conditions.

SYMBICORT should be administered with caution to patients being treated with MAO inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents. Caution should also be exercised in patients on long-term ketoconazole and other known potent CYP3A4 inhibitors.

The most common adverse reactions ≥ 3% reported in clinical trials included nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis.

Indications

SYMBICORT is indicated for the treatment of asthma in patients 12 years and older (also see boxed WARNING).

SYMBICORT is NOT indicated for the relief of acute bronchospasm and should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma.

Please see full Prescribing InformationAdobe PDF documentOpens in a new window, including boxed WARNING.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call
1-800-FDA-1088.

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