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Adverse Reactions

12-week study: Adverse reactions with ≥2% incidence in any treatment group

ADVERSE REACTION BREO 100/25
(n=346)
BREO 200/25
(n=346)
FLUTICASONE
FUROATE 100 mcg
(n=347)
Headache
8% 8% 9%
Nasopharyngitis
6% 7% 7%
Influenza
3% 3% 1%
Upper Respiratory Tract Infection
2% 2% 3%
Sinusitis
1% 2% <1%
Bronchitis
<1% 2% 2%
Oropharyngeal Pain
2% 2% 1%
Cough
2% 1% 1%

Placebo-controlled 12-week study: Adverse reactions with ≥2% incidence in any treatment group and more common than in placebo

ADVERSE REACTION BREO 100/25
(n-201)
FLUTICASONE
FUROATE 100 mcg
(n=205)
PLACEBO 
(n=203)
Nasopharyngitis
10% 7% 7%
Oral Candidiasis*
2% 2% 0%
Headache
5% 4% 4%
Oropharyngeal Pain
2% 2% 1%
Dysphonia 2% 1% 0%

*Includes oral candidiasis and oropharyngeal candidiasis

24-week study: In addition to those listed in the tables above, adverse reactions occurring in ≥2% of patients treated with BREO 200/25 included:

  • Viral Respiratory Tract Infection
  • Pharyngitis
  • Pyrexia
  • Arthralgia

52-week study: In addition to those listed in the tables above, adverse reactions occurring in ≥2% of patients treated with BREO 100/25 or BREO 200/25 for 12 months included:

  • Pyrexia
  • Back Pain
  • Extrasystoles
  • Upper Abdominal Pain
  • Respiratory Tract Infection
  • Allergic Rhinitis
  • Pharyngitis
  • Rhinitis
  • Arthralgia
  • Supraventricular Extrasystoles
  • Ventricular Extrasystoles
  • Acute Sinusitis
  • Pneumonia

24- to 76-week study: In a 24- to 76-week study of patients with a history of ≥1 asthma exacerbations within the previous 12 months:

  • Asthma-related hospitalizations occurred in 1% of patients treated with BREO 100/25 compared with 0.7% in patients treated with FF 100 mcg
  • There were no asthma-related deaths or asthma-related intubations observed in this trial

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REFERENCES:

  1. Bernstein DI, Bateman ED, Woodcock A, et al. Fluticasone furoate (FF)/vilanterol (100/25 mcg or 200/25 mcg) or FF (100 mcg) in persistent asthma. J Asthma. 2018;55(8):890-897.
  2. Bleecker ER, Lötvall J, O’Byrne PM, et al. Fluticasone furoate-vilanterol 100-25 mcg compared with fluticasone furoate 100 mcg in asthma: a randomized trial. J Allergy Clin Immunol Pract. 2014;2(5):553-561.
  3. Bateman ED, O’Byrne PM, Busse WW, et al. Once-daily fluticasone furoate (FF)/vilanterol reduces risk of severe exacerbations in asthma versus FF alone. Thorax. 2014;69(4):312-319.
  4. Data on file, GSK.
  5. O’Byrne PM, Bleecker ER, Bateman ED, et al. Once-daily fluticasone furoate alone or combined with vilanterol in persistent asthma. Eur Respir J. 2014;43:773-782.
  6. Kerwin E, Barnes N, Gibbs M, et al. Fluticasone furoate/vilanterol once daily improves night-time awakenings in asthma patients with night symptoms; post-hoc analyses of three randomized controlled trials. J Asthma. 2018;55(8):890-897.
  7. Data on file, GSK. Study 201594.