New Approach to Asthma: Treating the Two Main Causes of Symptoms With One Easy-to-Use(1) Device

New Treatment Option Available April 16

Is Both Highly Effective and Convenient



Apr 18, 2001, 01:00 ET from GlaxoSmithKline

    RESEARCH TRIANGLE PARK, N.C., April 16 /PRNewswire/ --  A new asthma
 treatment available in the U.S. starting today may change the way many of the
 17 million(2) Americans with asthma manage their condition.
     Advair(TM) Diskus(R) (fluticasone propionate and salmeterol inhalation
 powder) is the first and only product that allows people to effectively treat
 the two main components of asthma, inflammation and bronchoconstriction, with
 one easy-to-use(1) device. Both components play crucial roles in causing
 asthma symptoms such as shortness of breath, wheezing, chest tightness, and
 coughing. Patients take one inhalation of Advair twice each day from the
 Diskus device, a breath-activated powder inhaler. Advair Diskus does not
 replace fast-acting inhalers for the treatment of sudden symptoms.
     "Advair Diskus offers two major benefits to patients -- it's very
 effective and it's easy to use," said Stuart Stoloff, MD, a member of the
 expert medical panel that helped the National Institutes of Health develop
 current asthma treatment guidelines, and an associate clinical professor at
 the University of Nevada in Reno. "It gets to the root of the problem, making
 it easy for people to treat the two main components of asthma, literally in
 the same breath."
     Research has established that the two main causes of asthma symptoms are
 inflammation, or swelling and irritation inside the airways, and
 bronchoconstriction, tightening of the muscles that surround the airways.
 Optimal therapy for many asthma patients requires treatment of both of these
 components. Advair Diskus contains both an inhaled corticosteroid (fluticasone
 propionate) to reduce inflammation and an inhaled long-acting bronchodilator
 (salmeterol) to help prevent bronchoconstriction.
 
     Clinical Trials
     Trials involving more than 1,200 patients evaluated Advair Diskus using
 several measures, including lung function, protection against worsening
 asthma, rescue medication use, and asthma symptoms.(3,4)
     In a clinical trial(3) conducted in patients who were symptomatic while
 receiving salmeterol alone or low to moderate doses of inhaled corticosteroids
 alone, Advair Diskus 100/50 was compared with fluticasone propionate 100 mcg
 alone and salmeterol 50 mcg inhalation powders alone, resulting in
 significantly greater improvement in lung function and superior protection
 against worsening asthma.
     Other endpoints that were measured in this study showed that Advair Diskus
 100/50, compared with fluticasone propionate 100 mcg alone or salmeterol 50
 mcg alone provided significantly more symptom-free days and resulted in
 significantly greater reduction in the need for rescue albuterol.
     In addition, most of the patients who received Advair Diskus 100/50 had a
 clinically significant improvement in lung function within 30-60 minutes of
 taking the first dose.
     Clinical trials with Advair Diskus showed that it was generally well
 tolerated and had a safety profile similar to that of its individual
 components given concurrently at the same doses.
 
     The Diskus Inhaler
     The Diskus device is easy to use(1): patients simply open, click the lever
 to prepare the dose, inhale when they are ready, and then close the device.
     Unlike traditional aerosol inhalers, the Diskus is breath-activated:
 patients use their own breath to inhale pre-measured doses of medication. No
 hand-breath coordination or spacers are needed, and research shows that even
 patients with severely compromised lung function (FEV1 20-30 percent of
 predicted) are able to get consistent and effective doses.
     A built-in dose counter helps patients keep track of remaining doses. Each
 Diskus device contains 60 doses (a 30-day supply of medication). Doses are
 individually measured and sealed in blister strips that help protect the
 medication from temperature and humidity changes.
 
     Global Experience
     Advair Diskus is currently available in 38 countries, where it is also
 sold under the trade names Seretide(R) and Viani(R). It was first approved in
 Sweden in December 1998 and is now marketed in many parts of Europe, Latin
 America, Asia, and in Canada. The product was introduced in the United Kingdom
 in 1999, where it is called Seretide. "The interest in Seretide has been
 remarkably high," said Tim Clark, MD, professor of pulmonary medicine,
 National Heart and Lung Institute, Imperial College, London. "Both patients
 and physicians appreciate the combination of convenience and effectiveness
 that this treatment offers. It simplifies what many people need to do to help
 keep their asthma under control."
 
     Product Information
     Advair Diskus is indicated for the long-term, twice-daily, maintenance
 treatment of asthma in patients 12 years of age and older. It is not indicated
 for the relief of acute bronchospasm.
     Advair Diskus is available in three strengths for dosing flexibility:
 Advair Diskus 100/50, Advair Diskus 250/50 and Advair Diskus 500/50. Each
 strength of Advair Diskus contains 50 mcg of salmeterol and either 100 mcg,
 250 mcg or 500 mcg of fluticasone propionate.
     Advair Diskus does not replace fast-acting inhalers for the treatment of
 sudden symptoms and should not be taken more than twice a day. People
 switching from an oral steroid like prednisone to Advair, which contains an
 inhaled steroid, need to be especially careful. While adjusting to the switch,
 a person is not as able to heal after surgery, infection, or serious injury.
 Advair should be used with caution in patients with cardiovascular disorders.
 Some patients may experience an increase in blood pressure or heart rate.
     Advair Diskus was developed and is marketed by GlaxoSmithKline
 (NYSE:   GSK), one of the world's leading research-based pharmaceutical and
 health care companies. GlaxoSmithKline is committed to improving the quality
 of human life by enabling people to do more, feel better and live longer.
 
     References
 
     1. Boulet LP, et al. Comparison of Diskus inhaler, a new multidose powder
 inhaler, with Diskhaler inhaler for the delivery of salmeterol to asthmatic
 patients. J Asthma. 1995;32(6):429-436.
 
     2. US Centers for Disease Control and Prevention. Forecasted state-
 specific estimates of self-reported asthma prevalence - United States, 1998.
 Morbidity and Mortality Weekly Report. 1998;47.
 
     3. Kavuru M, et al. Salmeterol and fluticasone propionate combined in a
 new powder inhalation device for the treatment of asthma: A randomized,
 double-blind, placebo-controlled trial. J Allergy Clin Immunol. 2000 June;105
 (6, Part 1):1108-1116.
 
     4. Shapiro G, et al. Combined salmeterol 50 mcg and fluticasone propionate
 250 mcg in the Diskus device for the treatment of asthma. Am Jr Respir Crit
 Care Med. 2000;161:527-534.
 
     For full Advair Diskus prescribing information, please contact Lisa
 Behrens or Bert Kittner at 919-483-2839.
 
 

SOURCE GlaxoSmithKline
    RESEARCH TRIANGLE PARK, N.C., April 16 /PRNewswire/ --  A new asthma
 treatment available in the U.S. starting today may change the way many of the
 17 million(2) Americans with asthma manage their condition.
     Advair(TM) Diskus(R) (fluticasone propionate and salmeterol inhalation
 powder) is the first and only product that allows people to effectively treat
 the two main components of asthma, inflammation and bronchoconstriction, with
 one easy-to-use(1) device. Both components play crucial roles in causing
 asthma symptoms such as shortness of breath, wheezing, chest tightness, and
 coughing. Patients take one inhalation of Advair twice each day from the
 Diskus device, a breath-activated powder inhaler. Advair Diskus does not
 replace fast-acting inhalers for the treatment of sudden symptoms.
     "Advair Diskus offers two major benefits to patients -- it's very
 effective and it's easy to use," said Stuart Stoloff, MD, a member of the
 expert medical panel that helped the National Institutes of Health develop
 current asthma treatment guidelines, and an associate clinical professor at
 the University of Nevada in Reno. "It gets to the root of the problem, making
 it easy for people to treat the two main components of asthma, literally in
 the same breath."
     Research has established that the two main causes of asthma symptoms are
 inflammation, or swelling and irritation inside the airways, and
 bronchoconstriction, tightening of the muscles that surround the airways.
 Optimal therapy for many asthma patients requires treatment of both of these
 components. Advair Diskus contains both an inhaled corticosteroid (fluticasone
 propionate) to reduce inflammation and an inhaled long-acting bronchodilator
 (salmeterol) to help prevent bronchoconstriction.
 
     Clinical Trials
     Trials involving more than 1,200 patients evaluated Advair Diskus using
 several measures, including lung function, protection against worsening
 asthma, rescue medication use, and asthma symptoms.(3,4)
     In a clinical trial(3) conducted in patients who were symptomatic while
 receiving salmeterol alone or low to moderate doses of inhaled corticosteroids
 alone, Advair Diskus 100/50 was compared with fluticasone propionate 100 mcg
 alone and salmeterol 50 mcg inhalation powders alone, resulting in
 significantly greater improvement in lung function and superior protection
 against worsening asthma.
     Other endpoints that were measured in this study showed that Advair Diskus
 100/50, compared with fluticasone propionate 100 mcg alone or salmeterol 50
 mcg alone provided significantly more symptom-free days and resulted in
 significantly greater reduction in the need for rescue albuterol.
     In addition, most of the patients who received Advair Diskus 100/50 had a
 clinically significant improvement in lung function within 30-60 minutes of
 taking the first dose.
     Clinical trials with Advair Diskus showed that it was generally well
 tolerated and had a safety profile similar to that of its individual
 components given concurrently at the same doses.
 
     The Diskus Inhaler
     The Diskus device is easy to use(1): patients simply open, click the lever
 to prepare the dose, inhale when they are ready, and then close the device.
     Unlike traditional aerosol inhalers, the Diskus is breath-activated:
 patients use their own breath to inhale pre-measured doses of medication. No
 hand-breath coordination or spacers are needed, and research shows that even
 patients with severely compromised lung function (FEV1 20-30 percent of
 predicted) are able to get consistent and effective doses.
     A built-in dose counter helps patients keep track of remaining doses. Each
 Diskus device contains 60 doses (a 30-day supply of medication). Doses are
 individually measured and sealed in blister strips that help protect the
 medication from temperature and humidity changes.
 
     Global Experience
     Advair Diskus is currently available in 38 countries, where it is also
 sold under the trade names Seretide(R) and Viani(R). It was first approved in
 Sweden in December 1998 and is now marketed in many parts of Europe, Latin
 America, Asia, and in Canada. The product was introduced in the United Kingdom
 in 1999, where it is called Seretide. "The interest in Seretide has been
 remarkably high," said Tim Clark, MD, professor of pulmonary medicine,
 National Heart and Lung Institute, Imperial College, London. "Both patients
 and physicians appreciate the combination of convenience and effectiveness
 that this treatment offers. It simplifies what many people need to do to help
 keep their asthma under control."
 
     Product Information
     Advair Diskus is indicated for the long-term, twice-daily, maintenance
 treatment of asthma in patients 12 years of age and older. It is not indicated
 for the relief of acute bronchospasm.
     Advair Diskus is available in three strengths for dosing flexibility:
 Advair Diskus 100/50, Advair Diskus 250/50 and Advair Diskus 500/50. Each
 strength of Advair Diskus contains 50 mcg of salmeterol and either 100 mcg,
 250 mcg or 500 mcg of fluticasone propionate.
     Advair Diskus does not replace fast-acting inhalers for the treatment of
 sudden symptoms and should not be taken more than twice a day. People
 switching from an oral steroid like prednisone to Advair, which contains an
 inhaled steroid, need to be especially careful. While adjusting to the switch,
 a person is not as able to heal after surgery, infection, or serious injury.
 Advair should be used with caution in patients with cardiovascular disorders.
 Some patients may experience an increase in blood pressure or heart rate.
     Advair Diskus was developed and is marketed by GlaxoSmithKline
 (NYSE:   GSK), one of the world's leading research-based pharmaceutical and
 health care companies. GlaxoSmithKline is committed to improving the quality
 of human life by enabling people to do more, feel better and live longer.
 
     References
 
     1. Boulet LP, et al. Comparison of Diskus inhaler, a new multidose powder
 inhaler, with Diskhaler inhaler for the delivery of salmeterol to asthmatic
 patients. J Asthma. 1995;32(6):429-436.
 
     2. US Centers for Disease Control and Prevention. Forecasted state-
 specific estimates of self-reported asthma prevalence - United States, 1998.
 Morbidity and Mortality Weekly Report. 1998;47.
 
     3. Kavuru M, et al. Salmeterol and fluticasone propionate combined in a
 new powder inhalation device for the treatment of asthma: A randomized,
 double-blind, placebo-controlled trial. J Allergy Clin Immunol. 2000 June;105
 (6, Part 1):1108-1116.
 
     4. Shapiro G, et al. Combined salmeterol 50 mcg and fluticasone propionate
 250 mcg in the Diskus device for the treatment of asthma. Am Jr Respir Crit
 Care Med. 2000;161:527-534.
 
     For full Advair Diskus prescribing information, please contact Lisa
 Behrens or Bert Kittner at 919-483-2839.
 
 SOURCE  GlaxoSmithKline