The U.S. Food and
Drug Administration (FDA) has approved the first and only asthma medication
that simultaneously treats both of the underlying components of the disease:
inflammation and bronchoconstriction. The new medication will offer many
asthma patients an effective and convenient approach to treating their
condition, improving their lung function and helping control their symptoms.
Advairtm Diskus ® (fluticasone propionate and salmeterol inhalation
powder) is the first and only dual-action asthma medication to be approved for
use in the United States. It contains an inhaled corticosteroid (fluticasone
propionate) to reduce swelling and irritation inside the lungs' airways
(inflammation), and an inhaled long-acting bronchodilator (salmeterol) to help
prevent tightening of the muscles that surround the airways
(bronchoconstriction). Together, inflammation and bronchoconstriction cause
asthma symptoms, including shortness of breath, wheezing, chest tightness, and
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.
"With the approval of Advair Diskus, we have a medicine that can have a
major impact on asthma management," said Dr. Stuart Stoloff, clinical
associate professor of family and community medicine at the University of
Nevada, and a member of the expert medical panel that helped develop current
national asthma treatment guidelines. "It can help people control their
asthma by getting to the root of the problem -- treating asthma's two
components at once, and literally in the same breath. It's like giving asthma
the one-two punch."
Patients take one inhalation twice a day, once in the morning and once at
night, from the Diskus, a breath-activated powder inhaler.
A New Approach to Asthma Treatment
For many of the 17 million Americans with asthma, undertreatment can mean
frequent symptoms and attacks, missed work and school, activity limitations,
and a decline in lung health and function. Along with education about proper
asthma management, effective and easy-to-use medications are a crucial part of
keeping asthma under control and lessening the impact of the disease.
Advair Diskus represents an evolution in thinking about effective asthma
management. Most asthma treatments have been designed to either relieve
bronchoconstriction, by relaxing the smooth muscle surrounding the airways, or
reduce airway inflammation, by blocking cellular processes that can lead to
chronic swelling and irritation in the airways. However, research has revealed
that both bronchoconstriction and inflammation play crucial roles in the
disease and that both contribute to asthma symptoms. Hence the dual-component
approach of Advair Diskus.
Current national asthma treatment guidelines, published by the National
Heart, Lung, and Blood Institute,(1) recommend using an inhaled long-acting
bronchodilator with inhaled corticosteroids as one of the preferred treatment
options for asthma patients who have daily symptoms.
Clinical trials with Advair Diskus 100/50 and Advair Diskus 250/50 showed
that treating both components of asthma (inflammation and bronchoconstriction)
was associated with greater asthma control than either fluticasone propionate
or salmeterol inhalation powders alone at the same doses.
Trials involving more than 1,200 patients evaluated several measures --
including lung function, protection against worsening asthma, rescue
medication use, symptoms, and nighttime awakenings due to asthma. Following
is a summary of trial results(2) for Advair Diskus 100/50 (fluticasone
propionate 100mcg and salmeterol 50mcg), the lowest strength of the
Lung function: Advair Diskus 100/50 improved FEV1 ("forced expiratory
volume in one second," a standard measure of lung function) by 25 percent at
study endpoint compared to baseline, versus 15 percent for fluticasone
propionate 100mcg alone and five percent for salmeterol 50mcg alone.
Protection against worsening asthma: Only three percent of patients taking
Advair Diskus 100/50 withdrew from the study because their asthma was getting
worse, compared to 11 percent for fluticasone propionate 100mcg alone and
35 percent for salmeterol 50mcg alone. The trial criteria for worsening asthma
included a decrease in lung function, an increase in the use of rescue
albuterol, and an emergency room visit or hospitalization due to asthma.
Other endpoints that were measured in this study included:
Symptom reduction: Patients taking Advair Diskus 100/50 had nearly twice
as many symptom-free days (48 percent) at study endpoint compared to baseline
as those taking fluticasone propionate 100mcg alone (27 percent) and
salmeterol 50mcg alone (21 percent).
Albuterol use: Advair Diskus 100/50 resulted in a reduction in use of
rescue albuterol that at study endpoint compared to baseline was more than six
times greater than salmeterol 50mcg alone and more than four times greater
than fluticasone propionate 100mcg alone.
Onset of action: Approximately half of all patients who received Advair
Diskus 100/50 had clinically significant improvement in lung function (greater
than or equal to 15% improvement in FEV1) within 30 minutes of taking the
first dose; approximately two-thirds of all patients demonstrated greater than
or equal to 15% improvement in FEV1 within one hour. (It is important to
remember, however, that Advair Diskus will not replace fast-acting inhalers
used for sudden attacks.)
Nighttime awakenings were also evaluated in this study. Despite little
room for improvement, Advair Diskus 100/50 further increased the percentage of
nights without awakenings compared to fluticasone propionate and salmeterol
alone at the same doses. These differences were significant versus salmeterol,
and they approached, but did not reach, statistical significance versus
Trials with Advair Diskus showed that it was generally well tolerated and
had a favorable safety profile similar to that of its individual components
given concurrently at the same doses. The most common side effects (greater
than or equal to 8%) observed in the studies were upper respiratory tract
infection, sore throat, viral respiratory infection, bronchitis and headache.
Advair Diskus should not be used for transferring patients from oral
corticosteroid therapy. Particular care is needed for patients who have been
transferred from oral corticosteroids to inhaled corticosteroids because,
while adjusting to the switch, a patient may not be able to heal after
surgery, infection, or serious injury. Advair Diskus should not be used to
relieve acute asthma symptoms. Patients should be prescribed a short-acting
beta-agonist (e.g., albuterol) when acute symptoms occur. Also, Advair Diskus
should not be initiated in patients during rapidly deteriorating or
potentially life-threatening episodes of asthma.
Advair Diskus will be available in three strengths: Advair Diskus 100/50,
Advair Diskus 250/50 and Advair Diskus 500/50. Each contains 50mcg of
salmeterol and either 100mcg, 250mcg or 500mcg of fluticasone propionate.
Advair Diskus was developed and is marketed by Glaxo Wellcome
(1) Practical Guide for the Diagnosis and Management of Asthma, National
Heart, Lung, and Blood Institute, National Institutes of Health. NIH
Publication No. 97-4053, October 1999.
(2) Kavuru M, Melamed J, Gross G, and 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.
For full Advair Diskus prescribing information, please contact Lisa
Behrens or Veronica Grosshandler at 919-483-2839.