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| |  ALA/ATS MEETING: Study Results Show QVAR Is Safe And Effective In Asthma Patients HONOLULU, HI -- May 5, 1999 -- The safety of Hoechst Marion Roussel's QVAR(TM) (hydrofluoroalkane-134a beclomethasone dipropionate) was examined in four abstracts of a long-term safety study presented this week at the American Lung Association/American Thoracic Society (ALA/ATS) and Asthma '99 meetings. A long-term, open-label, multinational study was conducted to determine the long-term safety of QVAR, an ozone-friendly, pressurised metered dose inhaler (pMDI). The study examined the safety of the product through 12 months; the ease of switching patients from chlorofluorocarbon (CFC)-BDP, a traditional CFC-propelled pMDI, QVAR; and asthma control following a switch from CFC-BDP to QVAR. "The results of this long-term study are encouraging, particularly when a switch to CFC-free inhalers is imminent," said Robert Cohen, M.D., of the Allergy & Asthma Center in Lawrenceville, GA. and an investigator of the study. Patients stabilised on CFC-BDP were randomised to either remain on their CFC-BDP dose (400-1600 micrograms (mcg) per day) or switch to approximately half the dose (200-800 mcg per day) of QVAR. Approximately one-in-five (20.1 percent) patients in the CFC-BDP group reported adverse events attributed to their inhaler compared with 16.7 percent in the QVAR group. A trend existed for QVAR-treated patients to have a later time to onset of the first occurrence of either an acute asthma episode or increased asthma symptoms and to suffer fewer attacks than CFC-BDP-treated patients. The proportion of patients who suffered one or more acute asthma exacerbations during the 12-month treatment period was 16.9 percent for QVAR and 22.7 percent for CFC-BDP. Morning peak expiratory flow (AM PEF) was maintained over the 12 months for QVAR and CFC-BDP. No differences or clinically significant changes from baseline in mean plasma cortisol levels were found between the groups. The proportion of patients with a plasma cortisol level below the lower limit of the normal reference range was small for the two treatment groups (1.3-6.0 percent QVAR /3.3-8.5 percent CFC-BDP). The number of patients with an abnormal response to cosyntropin at month 12 also was small (1 QVAR/0 CFC-BDP). Cosyntropin is a synthetic hormone that stimulates the adrenal glands and enables the measurement of the level of cortisol in an individual's bloodstream. A majority of patients (60 percent) expressed an overall preference for QVAR while 13 percent expressed an overall preference for CFC-BDP. Eighty-eight percent found the QVAR inhaler to be an acceptable or very acceptable alternative to the previous CFC-BDP MDI and 96 percent found the switch to the new QVAR inhaler to be very easy or somewhat easy. Furthermore, during the first two weeks following randomisation, 80 percent of patients switched from CFC-BDP to QVAR remained stable with regard to their AM PEF, 15 percent experienced an improvement in asthma control and five percent worsened. In the CFC-BDP group, 75 percent remained stable, 14 percent improved and 10 percent worsened. In addition, mean change from baseline in FEV1 as a percent of predicted, at the end of eight weeks of treatment, demonstrated no statistical difference between the groups. Another abstract presented at the ALA/ATS meeting, 400 MCG QVAR Extrafine Aerosol demonstrated Equivalent Improvement in Asthma Control to 400 MCG CFC-Fluticasone Propionate, examined asthma control in patients taking 400 mcg HFA-134a BDP and 400 mcg CFC-fluticasone proprionate (FP) (Flovent(TM)) over six weeks. Patients who were still experiencing symptoms on doses as high as 500 mcg daily CFC-BDP or 250 mcg CFC-FP were randomised to receive either 400 mcg QVAR or 400 mcg CFC-FP. At baseline, the average AM PEF for the QVAR group was 381.3 (plus or minus 9.77) litres per minute compared to 378.3 (plus or minus 10.78) for the CFC-FP group. Total daily beta-agonist puffs at baseline for the QVAR group was 4.98 (plus or minus 0.435) compared to 4.96 (plus or minus 0.477) for the CFC-FP group. At weeks five to six, the average AM PEF for the QVAR group was 398.9 (plus or minus 10.01) compared to 404.3 (plus or minus 10.79) for the CFC-FP group. Total daily beta-agonist puffs at weeks five to six for the QVAR group was 3.49 (plus or minus 0.380) compared to 3.85 (plus or minus 0.409) for the CFC-FP group. Also, there was no significant difference between groups in plasma cortisol values or reported deterioration in asthma. A peak flow meter is a small, easy-to-use instrument that measures lung function. The peak flow meter measures how fast a person can blow out air after a maximum inhalation. This is called the peak expiratory flow rate, or PEFR. People with asthma cannot always feel the early changes taking place in their airways because these changes often occur gradually. By the time symptoms of asthma develop, a person can be experiencing a 25 percent or greater decrease in lung function. Use of a peak flow meter provides an important indicator of asthma control. It can serve as an early warning sign and in some cases may show a decrease in lung function one to three days before other respiratory symptoms become evident. The peak flow numbers, along with early warning signs, can be used to make decisions about asthma treatment.
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