Evaluate the Effects of Formoterol and Beclomethasone Dipropionate Combination Therapy on Small Airways Function
Evaluate the Effects of Formoterol and Beclomethasone Dipropionate Combination Therapy on Small Airways Function
Inuvair® is a novel fixed combination product used in the treatment of asthma and under
 clinical development for the treatment of COPD. Thanks to the extrafine particle size, it is
 able to target the whole bronchial tree, including the small airways and hence, is expected
 to act in these airways and it may thus be beneficial in COPD in that sense. In COPD, its
 action on the small airways is not directly demonstrated thus far. By way of contrast, dear
 evidence is present that treatment with bronchodilators alone does not beneficially alter
 small airway function. The study hypothesis states that the effects of inhaled
 corticosteroids or ICS/LABA combinations on small airway is present and can be objectivated.
Inclusion Criteria:

 -  clinical diagnosis COPD according to last updated GOLD guidelines (post-
 bronchodilator FEV/FVC below 0,70, FEV1 <80% predicted)

 -  ex-smokers (ie 1 year from the last cigarette) with at least 10 pack years.

 -  GOLD stage II and III (FEV1 > 30% predicted)

 -  by preference naïve to inhaled corticosteroids; in those taking inhaled
 corticosteroids this medication will be stopped 1 month prior to enrollment in the
 study

 -  Patients must have proven small airways dysfunction on routine spirometry as reflected
 by a drop in FEF25-75 and FEF75 of at least 50%. Moreover, patients must have proven
 small airways dysfunction on MBW as reflected by Sacin >0,120 that is considered
 abnormal.

 Exclusion Criteria:

 -  Current smoking

 -  Active COPD exacerbation

 -  gold stage I and IV