close

Clinical Trials

Date: 2012-09-04

Type of information:

phase: 2

Announcement: completion and reporting of data from a phase 2 clinical trial
The data was presented by the trial’s Principal Investigator, Professor Mario Cazzola, at the European Respiratory Society (ERS) Annual Congress in Vienna.

Company: Verona Pharma (UK)

Product: RPL554

Action mechanism: RPL554 is a long acting bronchodilator/anti-inflammatory drug belonging to a class of drugs known as a mixed phosphodiesterase (PDE) 3/4 inhibitor. Verona Pharma is investigating its use for the treatment of respiratory diseases including asthma, chronic obstructive pulmonary disease (COPD) and allergic rhinitis (hay fever).

Disease: chronic obstructive pulmonary disease (COPD)

Therapeutic area: Respiratory diseases

Country: Italy

Trial details: The Phase II trial was a placebo-controlled cross-over study in 12 patients with mild to moderate COPD and was carried out at the Tor Vergata Clinic at the University of Rome, Italy.

Latest news: Verona Pharma, the drug discovery and development company with first-in-class drugs to treat respiratory diseases, has announced the completion and reporting of data from a clinical trial with its dual PDE3 and 4 inhibitor RPL554, in patients with chronic obstructive pulmonary disease (COPD). 
The data showed that a single dose of nebulized RPL554 to patients with COPD produced a rapid bronchodilator response, greater than a 15% increase in FEV1 (forced expiratory volume at 1 second). This magnitude of bronchodilator response was significantly larger than that produced by placebo and appeared to be at least equivalent to that produced by a standard dose of the reference bronchodilator beta2-agonist salbutamol in these patients.  In addition, inhalation of 0.018 mg/kg of RPL554 was well tolerated and did not cause any significant adverse effects.
This completes the first bronchodilator study in mild to moderate COPD patients at the Tor Vergata Clinic in Rome and is an expansion of the pilot part of the study announced by the Company on 10 November 2011.

Is general: Yes