Cystic fibrosis (CF) is a chronic condition in which patients experience difficulty breathing because of the accumulation of thick mucus in the lungs and the inflammation caused by its buildup.
In 1997, Flovent was approved by the U.S. Food and Drug Administration (FDA) for use in asthma patients age 4 and older. It is also used to treat patients with rhinitis (runny nose) due to seasonal allergies. Also available as an inhalation powder sold as Arnuity Ellipta by GSK, it was approved by the FDA for asthma patients age 12 and older.
Flovent is not an approved treatment for patients with CF. However, the CF center at Stanford and the Cystic Fibrosis Foundation have recommended its use in CF patients to help relieve chest congestion and improve breathing.
In Canada, public funding is available for Flovent based on the province. For instance, in Nova Scotia, Flovent is covered by public funding for CF patients, but those in Alberta will have to pay for the treatment.
How fluticasone works
Fluticasone belongs to a group of therapeutics called corticosteroids — a synthetic version of the naturally occurring hormone cortisol. Corticosteroids are anti-inflammatory agents and help to subdue an overactive immune system.
The exact mechanism of fluticasone is not completely clear. However, it has been shown to lower the production of molecules that trigger inflammation in lung cells and prevent tissue damage. As a result, fluticasone reduces airway swelling and irritation and supports easy breathing.
Fluticasone in clinical trials
Fluticasone has not been thoroughly tested in clinical trials for patients with CF specifically.
One study (NCT00220259) evaluated the effect of long-term use of fluticasone in CF patients. Researchers assessed the effect of fluticasone by withdrawing it after treatment for two months and monitored patients for chest exacerbations. A total of 240 patients, age 6 and older, from 12 centers were included in this study. They were randomly assigned either to receive the treatment or a placebo for two months, after which they were again randomly chosen to receive their regular inhalation or a placebo for the next six months. The team monitored the patients for worsening lung condition, a decline in lung function, use of new antibiotics, or the need to use a bronchodilator.
In a similar study, 171 CF patients were randomly assigned to receive either fluticasone oral inhalation or a placebo for the two months. After that, the participants were again randomly selected to either continue fluticasone treatment or switch to a placebo for the next six months. Fewer patients in the fluticasone group (9 percent) left the study because of lung-related adverse events compared to those in the placebo group (15 percent). Researchers found that the time of onset of the first chest exacerbation episode was not different in the fluticasone and placebo groups. Similarly, both groups showed no significant change in lung function, antibiotic use, or the need for bronchodilator use. Overall, discontinuing long-term fluticasone use did not appear to be harmful to CF patients.
Common side effects associated with fluticasone use include headache, voice changes (hoarseness), fever, runny or stuffy nose, ear infection, painful white patches in the throat and mouth, and sore throat.
Some severe side effects may also occur, such as rash, itching, swelling of the face and throat, hives, difficulty breathing, wheezing, and coughing.
In some rare instances, prolonged use of fluticasone can result in vision problems such as cataracts or glaucoma.
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