LAS100977 in patients with persistent asthma

• Research type

  Research Study

• Full title

  A Phase IIa, randomised, single dose, double-blind, double dummy, 6 way complete cross-over, placebo controlled clinical trial to assess the efficacy, safety and tolerability of 4 doses of LAS100977 QD compared to placebo and an active comparator in patients with persistent asthma.

• IRAS ID

  79415

• Sponsor organisation

  Almirall. S.A.

• Eudract number

  2011-000428-14

• Research summary

  Asthma affects the airways ?? the tubes carrying air in and out of the lungs. People with asthma have sensitive airways which become irritated in some situations. The airways become narrow and sometimes produce more mucusflud that helps protect the airways) than usual. This makes it difficult to breathe.Asthma can??t be cured, but with the right treatment most people with asthma can lead normal lives. Inhaled corticosteroids (drugs similar to chemicals produced naturally by the human body) remain the main treatment for asthma and work by controlling its symptoms. The downside of corticosteroid treatment for asthma is their non-specific action (corticosteroids also affect other processes of the human body) and their side effects. LAS100977 belongs to a new therapeutic class of drugs currently being developed. Research has shown that LAS100977 has the potential to relieve asthma symptoms with once-daily treatment. LAS100977 works by attaching on a protein (Ç?2-adrenergic receptor) found on the surface of the cells that make up the lung airways and subsequently causing the airways to expand.Almirall is sponsoring a study to assess the effect, safety and tolerability of different single daily doses of LAS100977 in patients with persistent asthma. This study is randomised and double blind meaning that the treatment a patient will receive is allocated randomly, like tossing a coin, and neither the patient nor the study doctor will know which of the following six treatments the patient is receiving. -LAS100977 (0.313 micrograms) -LAS100977 (0.625 micrograms-LAS100977 (1.25 micrograms)-LAS100977 (2.5 micrograms)-Salbutamol ?? an approved asthma drug-placebo (sugar pill)This is a multicentre study which will take place in a maximum of 10 sites in total in Germany and in UK and is expected to recruit 54 patients.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/NW/0367

• Date of REC Opinion

  12 Jul 2011

• REC opinion

  Further Information Favourable Opinion