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Breo Ellipta Is New Drug Approved by FDA for the Treatment of Chronic Obstructive Pulmonary Disease
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clinnovo
Breo Ellipta a new drug was approved in May 10, 2013 by US-FDA for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. This drug is also approved to reduce exacerbations of COPD in patients having a history of exacerbations. Breo Ellipta was developed by GlaxoSmithKline and Theravance pharmaceuticals. The clinical trials of this drug included 7,700 subjects with COPD in two 6-months lung function trials, two 12-months exacerbation trials and 6 other trials of shorter duration.
COPD is a serious lung disease which is manifested by breathing difficulty and gradually worsens over time. Symptoms of the disease include chest tightness, chronic cough and excessive phlegm. Cigarette smoking is one of the leading causes of COPD. According to the National heart, lung and blood institute COPD is the third leading cause of death in the United States. COPD is characterized by occurrence of chronic bronchitis or emphysema, a pair of commonly co-existing diseases of the lungs in which the airways become narrow gradually which in turn limits airflow to and from the lungs, finally leading to shortness of breath (dyspnoea). In contrast to asthma the disease is usually poorly reversible. COPD is caused by noxious particles or gases, most commonly from tobacco smoking, which triggers an abnormal inflammatory response in the lungs .The diagnosis of COPD requires lung function tests. Important management strategies are smoking cessation, vaccinations, rehabilitation, and therapy (often using inhalers). Some patients need long-term oxygen therapy or even lung transplantation in severe cases.
Breo ellipta is a combination inhalation of fluticasone furoate (used as inhaled corticosteroid) and vilanterol which is used as long-acting beta-2-adrenergic agonist (LABA).This drug combination is indicated for the long-term, maintenance treatment of airflow obstruction in patients with COPD including chronic bronchitis and/or emphysema. Breo Ellipta 100 mcg/25 mcg has to be administered as inhalation once daily by the orally inhaled route only. The drug dosage 100mcg/25mcg refers to fluticasone furoate 100 mcg and vilanterol 25 mcg. In clinical trials subjects who were treated with the drug showed improved lung function and reduced exacerbations compared to placebo. This drug decreases inflammation in the lungs and helps the muscles around the airways of the lungs to stay relaxed thus increasing airflow and reduced exacerbations in patients with COPD. After inhalation, the patient has to rinse their mouth with water without swallowing to reduce the risk of oropharyngeal candidiasis. It is recommended that the drug should be taken at the same time every day.
Common side effects of Brea Ellipta include runny nose and sore throat, upper respiratory tract infection, headache, thrush in the mouth and/or throat. The use of this drug is contraindicated in patients having severe hypersensitivity to milk proteins or who have previously demonstrated hypersensitivity to either fluticasone furoate, vilanterol, or any of the excipients.
This medication should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing LABA, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled drugs. Patients using this drug should not use another medicine containing a LABA (e.g., Salmeterol, Formoterol fumarate, Arformoterol tartrate, Indacaterol) for any reason. LABA such as vilanterol, one of the active ingredients present in this drug increases the risk of asthma-related death. Thus it is not intended for the treatment of asthma. Systemic and local corticosteroid use may result in the increased risk of pneumonia in COPD. The more serious side effects of this drug include bone fracture and pneumonia but these are less common. The label of this drug will carry a warning of increased risk for asthma-related death.
Breathing is essential to sustain life. Breathing is regulated by the autonomous nervous system and we continue breathing throughout our life. Maintaining proper breathing process is essential for good health. Breathing helps in proper oxygen supply to all the cells and it is the key process helping our tissues and organs (composed of these cells) to function properly with enough supply of oxygen. In COPD patients due to various reasons, this breathing process becomes difficult and thus the new drug Breo Ellipta could be a pathfinder for the treatment of COPD.
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