August 31, 2015
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Roflumilast reduces allergen-induced airway inflammation in patients with asthma

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Various doses of roflumilast reduced allergen-induced airway inflammation in patients with asthma, according to study results.

“The studies presented here show that roflumilast has no acute bronchodilator actions in patients with mild to moderate asthma,” Philip Bardin, PhD, the director of the lung and sleep unit at Monash Health in Australia, and colleagues wrote. “This finding is not unexpected given that roflumilast is an anti-inflammatory agent and not a direct bronchodilator. However, the effects of roflumilast on airflow limitation in the allergen challenge model are notable.”

Bardin and colleagues reviewed data from eight placebo controlled, double blind phase 1 to 3 studies conducted across 14 sites in North America, Europe and South Africa from 1997 to 2005 to analyze the efficacy and mechanism of action of roflumilast in patients with asthma.

The analysis included 197 patients aged 18 to 70 years who either received 250 µg, 500 µg or 1,000 µg of roflumilast or placebo.

In one of the included studies, late asthmatic reaction reduced by 43% in patients treated with 500 µg of roflumilast (n = 20) compared with placebo (n = 21) (P = .001). Late asthmatic reaction also reduced by 27% in patients treated with 250 µg (n = 21) compared with placebo (P = .011).

Early asthmatic reaction also significantly decreased in patients who received 500 µg (28%; P = .005) and 250 µg (25%; P = .004) of roflumilast compared with placebo.

Another study demonstrated that a single dose of 1,000 µg (85%) of roflumilast improved forced expiratory volume in 1 second 9 hours after allergen challenge compared with placebo (76.1%) (P = .03).

A subgroup analysis from a different study indicated 500 µg roflumilast reduced sputum eosinophils by 43% in the intention-to-treat analysis (P = .021) and by 44% in the per-protocol analysis (P = .032) compared with placebo.

The adverse events patients experienced mostly mimicked side effects patients treated for COPD experience, according to the researchers.

“Overall, patients receiving roflumilast reported the same range of side effects — nausea, headache and diarrhea — as patients with COPD, regardless of background medication,” the researchers wrote. “However, unlike in COPD patients, weight loss as a side effect has not been an issue with roflumilast in asthma patients.” – by Ryan McDonald   

Disclosure: Bardin reports no relevant financial disclosures. Please see the full study for a list of all other researchers’ relevant financial disclosures.