Low-dose inhaled corticosteroids and the prevention of death from asthma

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The most commonly reported side effects were: oral thrush , nausea , headache , and pain in the pharynx or larynx . More rarely reported side effects (occurring in <1% of patients during the clinical trial) include: tachycardia , palpitations , dry mouth , allergic reaction ( bronchospasm , dermatitis , hives ), pharyngitis , muscle spasms , tremor , dizziness , insomnia , nervousness , and hypertension . Patients experiencing an allergic reaction or increase in difficulty breathing while using this medication should immediately discontinue its use and contact their physician. [4]

BREO ELLIPTA for the treatment of asthma was studied in 18 double-blind, parallel-group, controlled trials (11 with placebo) of 4 to 76 weeks' duration, which enrolled 9,969 subjects with asthma. BREO ELLIPTA 100/25 was studied in 2,369 subjects and BREO ELLIPTA 200/25 was studied in 956 subjects. While subjects aged 12 to 17 years were included in these trials, BREO ELLIPTA is not approved for use in this age group [see Use in Specific Populations ]. The safety data described below are based on two 12-week efficacy trials, one 24-week efficacy trial, and two long-term trials.

31 papers reporting the results of 26 trials were included in the review . For studies that compared a step down approach to a constant moderate/low ICS dose, there were no significant differences in lung function, symptoms, rescue medications or asthma control between the two treatment approaches. Significant but clinically small improvements in percent predicted FEV1 ( WMD , 95% CI to ) and non significant improvements in the change in morning PEF were found for high dose ICS compared to moderate dose ICS. There were no significant differences in efficacy between high and low dose ICS. For moderate dose ICS, compared to low dose ICS, there were significant improvements in the change in morning PEF l/min from baseline (WMD , 95% CI to ) and nocturnal symptoms (SMD -, 95% CI - to - ) . Commencing ICS at double or quadruple a base moderate or low dose had no greater effect than commencing with the base dose. Several studies reported greater improvement in airway hyperresponsiveness for high dose ICS.

Level of control (Columns 2 to 4) is based on the most severe component of impairment (symptoms and functional limitations) or risk (exacerbations). Assess impairment by patient's or caregiver's recall of events listed in Column 1 during the previous 2 to 4 weeks and by spirometry and/or peak flow measures. Symptom assessment for longer periods should reflect a global assessment, such as inquiring whether the patient's asthma is better or worse since the last visit. Assess risk by recall of exacerbations during the previous year and since the last visit. Recommendations for adjusting therapy based on level of control are presented in the last row.

Low-dose inhaled corticosteroids and the prevention of death from asthma

low-dose inhaled corticosteroids and the prevention of death from asthma

31 papers reporting the results of 26 trials were included in the review . For studies that compared a step down approach to a constant moderate/low ICS dose, there were no significant differences in lung function, symptoms, rescue medications or asthma control between the two treatment approaches. Significant but clinically small improvements in percent predicted FEV1 ( WMD , 95% CI to ) and non significant improvements in the change in morning PEF were found for high dose ICS compared to moderate dose ICS. There were no significant differences in efficacy between high and low dose ICS. For moderate dose ICS, compared to low dose ICS, there were significant improvements in the change in morning PEF l/min from baseline (WMD , 95% CI to ) and nocturnal symptoms (SMD -, 95% CI - to - ) . Commencing ICS at double or quadruple a base moderate or low dose had no greater effect than commencing with the base dose. Several studies reported greater improvement in airway hyperresponsiveness for high dose ICS.

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