Kathy Rickard

A comparison of multiple doses of fluticasone propionate and beclomethasone dipropionate in subjects with persistent asthma

BACKGROUND Inhaled corticosteroids are recommended for the treatment of persistent asthma. Comparative clinical studies evaluating 2 or more doses of these agents are few. OBJECTIVE We sought to compare the efficacy and safety of 2 doses of fluticasone propionate (88 micrograms twice daily and 220 micrograms twice daily) with 2 doses of beclomethasone dipropionate (168 micrograms twice daily and 336 micrograms twice daily) in subjects with persistent asthma. METHODS Three hundred ninety-nine subjects participated in this randomized, double-blind, parallel-group clinical trial. Eligible subjects were using daily inhaled corticosteroids and had an FEV1 of 45% to 80% of predicted value. Clinic visits, including spirometry, were conducted every 1 to 2 weeks. Subjects recorded symptoms, use of albuterol, and peak expiratory flows on daily diary cards. RESULTS Fluticasone propionate treatment resulted in significantly (P </=.034) greater improvements in objective pulmonary function parameters than did beclomethasone dipropionate treatment and significantly greater reductions in daily albuterol use (P </=.010) and asthma symptoms (P </=.027). Both low-dose (88 micrograms twice daily) and medium-dose (220 micrograms twice daily) fluticasone propionate significantly increased FEV1 compared with higher doses of beclomethasone dipropionate (P =. 006). Low-dose and medium-dose fluticasone propionate improved FEV1 by 0.31 L (14%) and 0.36 L (15%), respectively, compared with improvements of 0.18 L (8%) and 0.21 L (9%) with low-dose and medium-dose beclomethasone dipropionate. The adverse event profiles were similar for both medications. CONCLUSION Fluticasone propionate provides greater asthma control at roughly half the dose of beclomethasone dipropionate, with a comparable adverse event profile.

Impact of exhaled nitric oxide measurements on treatment decisions in an asthma specialty clinic

BACKGROUND Asthma management in an outpatient setting is best accomplished by clinical evaluation coupled with spirometry and symptom evaluation, but these assessments do not provide information about airway inflammation. Exhaled nitric oxide (fraction of exhaled nitric oxide [FeNO]) measures T-helper cell type 2-mediated airway inflammation and may be a useful adjunct in asthma management. OBJECTIVE To determine whether the use of FeNO in the specialist management of asthma results in more effective and cost-effective treatment decisions. METHODS Fifty subjects 7 to 60 years old with established asthma participated in this observational study. Subjects were evaluated by clinical examination, spirometry, and symptom assessment using the Asthma Control Test, and clinicians estimated airway inflammation and made treatment decisions based on these assessments. Then, FeNO was measured, and changes in therapy based on FeNO levels were documented. The estimated cost impact of using FeNO was calculated presuming ongoing FeNO use in patient management. RESULTS Without FeNO, the clinicians assessment of airway inflammation was incorrectly classified in 50% of subjects. FeNO results substantially altered treatment decisions in more than one third of subjects, notably medication augmentation in 10 (20%) and medication decreases in 8 (16%). Use of FeNO in addition to standard of care was estimated to save

40 Low-dose inhaled fluticasone propionate provides greater asthma symptom control as compared with oral zafirlukast in patients with persistent asthma

629 per subject per year. CONCLUSION Measurement of FeNO augments routine clinical assessment of asthma by measuring airway inflammation. Knowledge of FeNO affects medication treatment decisions to augment or decrease pharmacotherapy, which has important long-term asthma management implications, most notably the potential to lower the costs and morbidity associated with asthma exacerbation. TRIAL REGISTRATION ClinicalTrials.gov identifier NCT01729247.

A Cost Comparison of β2‐Agonist Bronchodilators Is Not a Cost‐Effectiveness Comparison

40 Low-Dose Inhaled Fluticasone Propionate Provides Greater Asthma Symptom Control as Compared With Oral Zaftrlukast in Patients With Persistent Asthma Michael Welch*, Christopher Kalbergf, Lisa Edwardsf, Marty Johnsonf. Kathy Rickardf *Allergy 19 Asthma Medical Group, San Diego, CA tGlaxo Wellcome, Research Triangle Park, NC The NIH guidelines for asthma management recognize inhaled corticosteroids as the most effective controller medications for the treatment of the inflammatory component of persistent asthma. Leukotrienes are a relatively new class of controller medications, but their position in asthma therapy is not fully established. In this l2week study, the effect of a low dose of inhaled fluticasone propionate (FP, 88mcg BID) on asthma symptom control was compared with oral zafulukast (ZAF, 20mg BID) in patients 5 I2 years of age with persistent asthma. Eligible patients used only short-acting beta2-agonists prior to study entry and demonstrated signs of inadequate asthma control. Baseline FEV I values (expressed as percent of predicted normal) were 67% in the FP group. and 68% in the ZAF group. Treatment with FP resulted in significantly greater improvements in all measures of asthma symptom control compared with ZAF.

Low-dose fluticasone propionate compared with montelukast for first-line treatment of persistent asthma: a randomized clinical trial.

In his recent article, “Cost Comparison of PIAgonist Bronchodilators Used in the Treatment of Asthma,”’ Dr. Charles Nightingale raises the point that clinicians must remain aware of the most cost-effective approach to providing effective clinical treatment of asthma with inhaled P2-agonist bronchodilators. The author’s understanding of what cost-effectiveness means and which therapies are most cost-effective, however, bears closer scrutiny. Dr. Nightingale states that “agents that can be dosed as needed (i.e., albuterol) are likely to be more cost-effective choices for formularies than bronchodilators such as salmeterol, which must be given twice/day on a regular basis.” This conclusion, however, is founded on several incorrect assumptions: the first is that salmeterol, a long-acting P2-agonist, is interchangeable with short-acting Pl-agonists (e .g . , albuterol) , regardless of the severity of the patient’s asthma. The most recent National Institutes of Health guidelines on the long-term management of asthma, known as the Global Initiative for Asthma (GINA) ,’ recommend that a short-acting bronchodilator be used as needed as a “reliever” for symptoms, and a long-acting bronchodilator be used daily as a “controller” for persistent symptoms. The guidelines further state that patients who require asthma medication more than once a week over a 3-month period (i.e., patients who progress from intermittent asthma to mild persistent asthma) should be treated with antiinflammatory medication, such as inhaled corticosteroids, with or without a daily longacting bronchodilator plus inhaled short-acting P2-agonists as needed (up to 4 times/day) to