According to a latest study, a once-daily treatment regimen of combined fluticasone furoate and vilanterol has shown improved results at reducing aggravated symptoms of chronic obstructive pulmonary disease (COPD). The researchers believed that there was a void for randomized trials to be conducted to treat conditions that are closer to normal clinical practices.
In 2013, the drug was approved for use in the United States by the Food and Drug Administration (FDA) for long-term maintenance treatment of airflow obstruction in patients with COPD. Since during that period few clinical trials were conducted that followed usual clinical practice guidelines, the researchers conducted the in-depth controlled trial.
In a controlled effectiveness trial conducted in 75 general practices, researchers assigned 2,799 COPD patients at random to a once-daily inhalable dose of fluticasone furoate at a dose of 100μg and vilanterol at a dose of 25μg, which was the fluticasone furoate-vilanterol group, or the normal care group.
The main outcome that the researchers looked at was the rate of severe or medium aggravated COPD symptoms in patients who had an incident of exacerbation within the last year. The findings were published in New England Journal of Medicine (NEJM).
Secondary outcomes included rates of primary care visits which included contact with a general practitioner, nurse, or other health care professional and secondary care visits that included inpatient admission, outpatient visit with a specialist, or visit to the emergency department, modification of the initial trial treatment for COPD, and the rate of exacerbations among patients who had had an exacerbation within 3 years before the trial.
The results showed significant improvement in the fluticasone furoate–vilanterol group. Patients had exacerbation incidents reduced by 8.4%, compared to the usual care. There was no statistical significant difference in group outcomes in the rates of the first moderate or severe exacerbation and the first severe exacerbation in the time-event analysis. There were no excessively serious side effects of pneumonia in the fluticasone furoate–vilanterol group. The numbers of other serious side effects were similar in the two groups.
COPD is associated with progressive airway obstruction which is not completely reversible, can raise the inflammation in the airways and systemic effects or comorbidities. The main reason for COPD symptoms to originate is tobacco smoking, but other factors can also give rise to COPD symptoms. Several pathobiological factors can give rise to symptoms such as genetic determinants, lung growth and environmental stimuli.
COPD symptoms can become aggravated, known as exacerbations, in case of allergic reactions, bacterial infections or viral infections or both in patients with severe disease 78% of the time. The comorbidities of COPD can include lung cancer, diabetes or ischæmic heart disease.
Bronchodilators constitute the mainstay of treatment: β2 agonists and long-acting anticholinergic agents are frequently used, the former often with inhaled corticosteroids which is the case in this study.
The researchers tried to match the conditions found in everyday clinical practices. The researchers concluded that an easy once-daily treatment regimen of combined inhaled dose of fluticasone furoate and vilanterol was associated at reducing aggravated symptoms or exacerbations of (COPD) more effectively than the usual care treatment provided by patients’ physicians with regard to the frequency of moderate or severe exacerbations and was not associated with a significantly higher risk of serious adverse events.
The combination of fluticasone furoate and vilanterol has been shown previously to result in lower rates of exacerbations of COPD than vilanterol alone in conventional randomized, controlled trials to test the efficacy of such a treatment. But this trial showed that a wider population can benefit from benefit from treatment with fluticasone furoate-vilanterol.
There were no serious adverse reactions of pneumonia but there was a growing trend towards it when compared to treatment with bronchodilators alone. Pneumonia incidents also increased when compared with usual care.
The strength of this trial lies in its area of innovation, as it took place in a single urban setting with many health records interconnected with an EHR. All treatment plans were carried out by the usual caregivers and monitored using the EHR.
Fluticasone furoate is a steroid hormone synthetically derived from fluticasone. It’s is sold by GSK as Veramyst nasal spray, mainly prescribed for treating seasonal and chronic allergic rhinitis also known as hay fever, and can be given to both adults and children older than 1 year of age.
Vilanterol is an ultra-long acting β2 adrenoreceptor agonist, which causes the smooth muscles in the body to relax. Hence the effect of Vilanterol is to relax the bronchital passageways in the lungs to make it easier to breathe.
The prescription drug Breo Ellipta is a combination of vilanterol and fluticasone furoate, and is manufactured by GSK as well. It is used to treat COPD including chronic bronchitis, emphysema or both. It is not used to relieve sudden breathing problems, hence it won’t replace an inhaler. Breo Ellipta is used to clear up allergies in patients 18 years or older and should only be used if a patient’s healthcare provider prescribes it.
Patients should also be aware of some of the side effects of fluticasone furoate-vilanterol spray which may include back pain, cough, headache, minor nosebleed and sore throat. In case of severe allergic reactions these side effects may also appear: rash, difficulty in breathing, extremely watery nose or eyes, unusual nausea or vomiting, unusual tiredness or weakness. In this case, seek medical attention immediately.
Besides improving symptoms, these treatments are also thought to lead to some degree of disease modification. This comparative effectiveness trial that was conducted in a population of patients with COPD was largely unsupervised over the year-long period for which the trial was conducted. this unsupervised method of conducting the trial allowed important factors in usual clinical care to be considered, such as adherence, frequency of dosing, and persistence of good inhaler technique, to come into play.
Future research should be directed towards the development of agents that notably affect the course of disease.