Studies confirm potential of oral COPD drug

An anti-inflammatory tablet being developed for the treatment of chronic obstructive pulmonary disease (COPD) significantly improved patients' lung function in four Phase III trials, researchers report.

The trials – published in the same issue of The Lancet – involved more than 4500 patients in ten countries. Two of the trials examined the effects of roflumilast after 12 months, whilst each of the other two trials had a follow-up period of six months. All participants were aged over 40 years and each received either 500 micrograms of roflumilast per day, or placebo.

The 12-month trials enrolled a total of 3091 patients with severely reduced airflow, bronchitic symptoms and a history of exacerbations. Pooled data showed that prebronchodilator FEV1 (forced expiratory volume in one second) increased by 48ml in those who received roflumilast compared with those who were given placebo. Furthermore, patients in the roflumilast group experienced 17% fewer moderate or severe exacerbations than those in the placebo group.1

The shorter trials tested roflumilast in 1676 patients with moderate-to-severe COPD who had impaired lung function despite bronchodilatory treatment. Compared with placebo, roflumilast improved prebronchodilator FEV1 by an average of 49ml in individuals already receiving salmeterol. The improvement was even greater in patients receiving tiotropium-an average of 80ml.2

Adverse effects associated with roflumilast included nausea, diarrhoea and weight loss.

Roflumilast – currently under development by Nycomed – is a phosphodiesterase 4 enzyme inhibitor, targeting cells and mediators in the body believed to be important in the COPD disease process. If approved, roflumilast would be the first oral anti-inflammatory treatment for COPD.

"COPD can devastate people's lives and exacerbations can be extremely frightening, so a novel tablet like roflumilast is really exciting for those of us treating patients. Roflumilast acts differently to bronchodilators as it acts on the underlying condition, not primarily impacting on everyday symptoms," says Peter Calverley, Professor of Respiratory Medicine at the University of Liverpool, UK, lead author of two of the studies.

Nycomed submitted an application for approval to market roflumilast to the European Medicines Agency earlier this year.

NICE guidance on COPD

REFERENCES

  1. Calverley PMA et al. Lancet 2009: 374; 685-94.
  2. Fabbri LM et al. Lancet 2009: 374; 695-703.
Want news like this straight to your inbox?
Sign up for our bulletins

Have you registered with us yet?

Register now to enjoy more articles and free email bulletins

Register
Already registered?
Sign in

Register or Subscribe to MIMS

GPs can get MIMS print & online and GPonline for free when they register online – take 2 minutes, and make sure you get your free MIMS access! If you're not a GP, you can subscribe to MIMS for full access.

Register or subscribe

MIMS Dermatology

Read the latest issue online exclusively on MIMS Learning.

Read MIMS Dermatology

MIMS Adviser

Especially created for prescribing influencers.

Request free copy

Mobile apps

MIMS: access the full drug database and quick-reference tables on the go

MIMS Diagnosis and Management: concise information on signs and symptoms, investigations and diseases