Sponsor: CHIESI Pharmaceuticals / Chiesi Farmaceutici S.p.A. (Chiesi)

 The study drug is a long-acting bronchodilator (a drug that widens the airways in the lungs to improve breathing). It is supplied as an aerosol spray in a device commonly known as a metered-dose inhaler (MDI). So far, studies have only been carried out in patients with asthma. The results in those patients has been encouraging and showed a significant improvement in the patients’ ability to perform the lung function testing that was part of the research study. These studies also have shown that the drug, in the doses tested, appears to be safe, with side effects not different from the ones seen with similar existing drugs.

 The aim of this study is to evaluate the effect of the investigational drug CHF 4226 on subjects  lung function 24 hours after inhalation, for 2 weeks.  The study doctor should then be able to find out what effects (good and bad) CHF 4226 may have for subjects with  COPD, and to find the best dose of CHF 4226 to use to treat COPD.

 CHF 4226 has been shown to work as a bronchodilator and it is hoped it will be helpful to patients with COPD. Bronchodilators relax some of the muscles that surround the airways, helping to make it easier to breathe. Since the goal of this study is to help determine the best dose of CHF 4226 to use, three different dosage strengths of CHF 4226 will be studied. The results from using these dosage strengths will be compared to those from a placebo.

 Study is 3-6 weeks long, and seeking male and female current or past smokers. Study procedures include: breathing tests, laboratory tests, EKG’s and possible over night  EKG monitoring.