GlaxoSmithKline announces extended asthma control therapy indication for children above a year of age.
GLAXOSMITHKLINE Pharmaceutical (GSK) recently announced an extended indication for fluticasone propionate 50mcg, a pressurised metered-dose inhaler which has a marked anti-inflammatory effect in the lungs.
An inhaled glucocorticosteroid, Flixotide™, which is available in a dosage of 50mcg, has now been approved for asthmatic children aged above one year. The drug reduces symptoms and exacerbations of asthma in patients previously treated with bronchodilator alone or with other prophylactic therapy .
“The option of this younger age indication spells good news for patients suffering from uncontrolled asthma. Asthma is the most common chronic disease among children. This scenario occurs in all countries regardless of level of development,” said Chairman of the Asthma Council Malaysia, Dr Norzila Mohamed Zainudin.
Globally, close to 300 million people suffer from asthma, and this figure is expected to rise by another 100 million by the year 2025.
Locally, the estimated prevalence of asthma in Malaysia is 4.2%. Among children up to 14 years old, the estimated prevalence is observed to be 4.5%, and among adults aged 15 years and above, it is 4.1% .
“Many asthma patients have unmet needs related to their illness, and unfortunately, this leads to poor asthma control. This can be attributed to the different perceptions of disease control and treatment goals by patients and their physicians.
Generally speaking, patients simply want to feel well and avoid disruption of their social activities, while physicians emphasise the need to reduce airway inflammation and hyperresponsivness to achieve asthma control.
This is especially important in asthmatic children to minimise airway remodelling, which may result in fixed airway obstruction later in their adult life,” added Dr Norzila.
Asthma is a chronic lung disease characterised by recurrent breathing problems and symptoms such as breathlessness, wheezing, chest tightness, and coughing.
During normal breathing, air flows freely into and out of the lungs. However, when asthma is not under control, the airways of the lungs become thick, swollen, and inflamed, making it overly sensitive to environmental changes and conducive for an asthma attack.
Asthma symptoms vary from hour to hour, from day to day, from week to week, and over months.
They are often worse at night and in the early hours of the morning. The severity of asthma also varies from individual to individual.
Although asthma cannot be cured, it can be effectively treated. Research shows that with proper treatment, nearly all asthma patients can achieve and maintain good asthma control, enabling them to participate in school, work, and other normal activities while preventing visits to the emergency department and hospital.
The causes of asthma are not well understood, and the rapid increase in asthma prevalence around the world is one of the biggest mysteries in modern medicine.
Ten years ago, scientists thought that diesel exhaust and other pollutants might be causing the asthma epidemic.
However, they now believe that the picture is more complex. Many scientists are examining the role of genetic factors in causing asthma, and researchers are also looking at how the immune system develops in early life.
The causes of asthma attacks, however, are better understood. People with asthma have chronic inflammation in their lungs and airways that narrow more easily than those of people without asthma in response to a variety of factors.
The factors that can set off an asthma attack (sometimes called “triggers”) include inhaled allergens (such as dust mites, pollen, and cat and dog allergens), tobacco smoke, air pollution, exercise, strong emotional expressions (such as crying or laughing hard), chemical irritants, and certain drugs (aspirin and beta-blockers).
Each person with asthma reacts to a different set of factors, and identification of these factors and how to avoid them is a major step for each individual in learning how to control their disease.
“Childhood asthma causes considerable morbidity especially during periods when it is insufficiently controlled. This is reflected in the frequent symptoms, higher rates of unscheduled emergency department visits and hospitalisation, as well as absenteeism from school. These combine to interfere with normal daily activities and education and result in a considerable burden for the whole family of an asthmatic child ,” explained medical affairs manager of GlaxoSmithKline, Dr Thravin G Nathan.
“While treatment has improved with the availability of first-line therapies, managing young children with asthma remains a challenge.
“Recognising this, fluticasone propionate 50mcg joins existing therapies to provide physicians with a new treatment option for those aged one to four years. With its proven safety profile in children, young asthmatics now have a first-line controller therapy,” he added.
A recent analysis concluded that for children with mild-to-moderate persistent asthma, low-dose fluticasone had lower cost and higher effectiveness compared with montelukast, especially in those with more airway inflammation.
Asthma medications are divided into two categories – the relievers and controllers. Reliever medications have a short term effect that can help stop the symptoms that accompany an asthma attack, while controller medications help with keeping the asthma under control over a period of time by reducing the inflammation and the mucous that is in the airways. Controller medications such as fluticasone also help to reduce the sensitivity of the lungs to any triggers that could cause an asthma attack.
A double-blind, placebo-controlled, six-month study conducted among 34 children aged between six and 24 months demonstrated the efficacy and safety of two doses of fluticasone propionate 50mcg in young children with recurrent wheezing and risk factors for asthma.
The solution had improved asthma symptoms without any significant side effects on growth, bone metabolism and serum cortisol levels .
The drug is not for use in acute attacks, but for routine long-term management, and treatment with it should not be stopped abruptly. Consult your doctor for further information.
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