Three (3) trials included adult and adolescent subjects aged 12 years and older: 1 trial compared fluticasone propionate/salmeterol inhalation powder (Advair Diskus) with fluticasone propionate inhalation powder , 1 trial compared mometasone furoate/formoterol with mometasone furoate, and 1 trial compared budesonide/formoterol with budesonide. Improvements in morning PEF observed with Advair Diskus 500/50 were similar to improvements observed with concurrent therapy.Reduction in asthma symptoms and use of rescue VENTOLIN Inhalation Aerosol and improvement in morning and evening PEF also occurred within the first day of treatment with Advair Diskus, and continued to improve over the 12 weeks of therapy in both trials.In a 12-week U.S. trial, Advair Diskus 100/50 twice daily was compared with fluticasone propionate inhalation powder 100 mcg twice daily in 203 children with asthma aged 4 to 11 years. In these 2 trials, exacerbations were defined as worsening of 2 or more major symptoms (dyspnea, sputum volume, and sputum purulence) or worsening of any 1 major symptom together with any 1 of the following minor symptoms: sore throat, colds (nasal discharge and/or nasal congestion), fever without other cause, and increased cough or wheeze for at least 2 consecutive days. There was not a symptomatic definition of exacerbation in these 2 trials. The photos shown are samples only Not all photos of the drug may be displayed. No tumors were seen at 200 mcg/kg (approximately 3 times the MRHDID for adults and children based on comparison of the AUCs).In a 24-month oral and inhalation carcinogenicity study in Sprague Dawley rats, salmeterol caused a dose-related increase in the incidence of mesovarian leiomyomas and ovarian cysts at doses of 680 mcg/kg and above (approximately 66 and 35 times the MRHDID for adults and children, respectively, on a mcg/mSalmeterol produced no detectable or reproducible increases in microbial and mammalian gene mutation in vitro.

Tell your doctor about any illness or infection you have had within the past several weeks.It is not known whether this medicine will harm an unborn baby. The incidence of pneumonia in the subjects treated with Advair Diskus was higher in subjects older than 65 years (9%) compared with the incidence in subjects younger than 65 years (4%). ο  increase in mucus (sputum) production                                   ο  chills          ο  change in mucus color                                                             ο  increased cough          ο  fever                                                                                         ο  increased breathing problems          ο  feeling tired                                                                              ο  nausea and vomiting          ο  lack of energy                                                                          ο  low blood pressure (hypotension)          ο  rash                                                                                            ο  swelling of your face, mouth, and tongue          ο  hives                                                                                          ο  breathing problems          ο  increased blood pressure                                                           ο  chest pain          ο  tremor                                                                                        ο  nervousness         •  upper respiratory tract infection                                                      •  bronchitis         •  throat irritation                                                                                •  cough         •  hoarseness and voice changes                                                         •  headache         •  thrush in your mouth or throat.

Subjects receiving Advair Diskus 100/50 had clinically meaningful improvements in overall asthma-specific quality of life as defined by a difference between groups of ≥0.5 points in change from baseline AQLQ scores (difference in AQLQ score of 1.25 compared with placebo).Efficacy results in this trial were similar to those observed in Trial 1.