CONTRAINDICATIONS
• ADVAIR DISKUS is contraindicated for primary treatment of status asthmaticus or other acute episodes of asthma or chronic obstructive pulmonary disease (COPD) where intensive measures are required.
• ADVAIR DISKUS is contraindicated in patients with severe hypersensitivity to milk proteins

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Indications for ADVAIR DISKUS 250/50 for COPD

  • ADVAIR DISKUS 250/50 is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. ADVAIR DISKUS 250/50 is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations.
  • ADVAIR DISKUS 250/50 twice daily is the only approved dosage for the treatment of COPD because an efficacy advantage of the higher strength ADVAIR DISKUS 500/50 over ADVAIR DISKUS 250/50 has not been demonstrated.
  • ADVAIR DISKUS is NOT indicated for the relief of acute bronchospasm.

In patients with COPD with a history of exacerbations, ADVAIR DISKUS 250/50 significantly reduced the mean annual rate of moderate/severe exacerbations by 30% vs salmeterol (P <0.001)."scrollbars=yes, resizable=yes, width=400, height=400,top=500, left=500"1

Study design: Head-to-head comparison of ADVAIR DISKUS 250/50 versus salmeterol 50 mcg, 52-week, randomized, double-blind, parallel-group, multicenter study. During a 4-week run-in, all patients were stabilized with ADVAIR DISKUS 250/50 twice daily (bid).

Patients: 782 patients (efficacy results based on 776 patients) with FEV1* ≤50% of predicted; mean baseline FEV1 33% of predicted with a history of ≥1 COPD exacerbation in the previous year that was moderate/severe.

COPD exacerbation criteria: Worsening of 2 or more major symptoms (dyspnea, sputum purulence, sputum volume) or 1 major and 1 minor symptom (sore throat, colds [nasal discharge and/or nasal congestion], fever without other cause, and increased cough or wheeze) for 2 or more consecutive days.

Criteria for exacerbation severity: Exacerbations were defined as moderate to severe if they required treatment with oral corticosteroids (OCS), antibiotics, or hospitalization.

No concurrent use of inhaled long-acting bronchodilators (beta-agonists and anticholinergics), inhaled corticosteroids, ipratropium/albuterol combination products, oral beta-agonists, and theophylline was allowed.

*FEV1 = forced expiratory volume in 1 second.

In a replicate study, ADVAIR DISKUS 250/50 significantly reduced the mean annual rate of exacerbations by 30% vs salmeterol, P <0.001."toolbar=yes, scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50"2

Adverse events reported for >5% of patients in either group"toolbar=yes, scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50"1


Adverse Event
ADVAIR DISKUS 250/50
(N = 394)
Salmeterol
(N = 388)
Any event, n (%) 347 (88) 334 (86)
Nasopharyngitis
151 (38)
141 (36)
Pharyngolaryngeal pain
137 (35)
138 (36)
Pyrexia
74 (19)
68 (18)
Headache
45 (11)
46 (12)
COPD
38 (10) 46 (12)
Rhinorrhea 39 (10) 45 (12)
Nasal congestion 34 (9) 36 (9)
Upper respiratory tract infection 31 (8) 31 (8)
Pneumonia 29 (7) 15 (4)
Diarrhea 24 (6) 25 (6)
Back pain 23 (6) 23 (6)
Sinusitis 28 (7) 17 (4)
Cough 14 (4) 25 (6)

In patients with COPD with a history of exacerbations, ADVAIR DISKUS 250/50 significantly reduced the mean annual rate of exacerbations requiring oral corticosteroids (OCS) by 40% vs salmeterol (P <0.001)."toolbar=yes, scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50"1

Study design: Head-to-head comparison of ADVAIR DISKUS 250/50 versus salmeterol 50 mcg, 52-week, randomized, double-blind, parallel-group, multicenter study. During a 4-week run-in, all patients were stabilized with ADVAIR DISKUS 250/50 twice daily.

Patients: 782 patients (efficacy results based on 776 patients) with FEV1* ≤50% of predicted; mean baseline FEV1 33% of predicted with a history of ≥1 COPD exacerbation in the previous year that was moderate/severe.

COPD exacerbation criteria: Worsening of 2 or more major symptoms (dyspnea, sputum purulence, sputum volume) or 1 major and 1 minor symptom (sore throat, colds [nasal discharge and/or nasal congestion], fever without other cause, and increased cough or wheeze) for 2 or more consecutive days.

Criteria for exacerbation severity: Exacerbations were defined as moderate to severe if they required treatment with OCS, antibiotics, or hospitalization.

No concurrent use of inhaled long-acting bronchodilators (beta-agonists and anticholinergics), inhaled corticosteroids, ipratropium/albuterol combination products, oral beta-agonists, and theophylline was allowed.

*FEV1 = forced expiratory volume in 1 second.

In a replicate study, ADVAIR DISKUS 250/50 significantly reduced the mean annual rate of exacerbations requiring OCS by 34% vs salmeterol, P <0.001.2

In the two 1-year trials, the most common events that occurred with a frequency of >5% and more frequently in the subjects treated with ADVAIR DISKUS than with salmeterol were nasopharyngitis, upper respiratory tract infection, nasal congestion, back pain, sinusitis, dizziness, nausea, pneumonia, candidiasis, and dysphonia.

Indications for ADVAIR DISKUS 250/50 for COPD

  • ADVAIR DISKUS 250/50 is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. ADVAIR DISKUS 250/50 is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations.
  • ADVAIR DISKUS 250/50 twice daily is the only approved dosage for the treatment of COPD because an efficacy advantage of the higher strength ADVAIR DISKUS 500/50 over ADVAIR DISKUS 250/50 has not been demonstrated.
  • ADVAIR DISKUS is NOT indicated for the relief of acute bronchospasm.

830422R0 March 2018