Formoterol HFA-pMDI versus Salmeterol HFA-pMDI on small airways

• Research type

  Research Study

• Full title

  A Single-centre, Double-blind, Double-dummy, Randomised, Crossover Study to investigate the effect of Formoterol HFA-pMDI versus Salmeterol HFA-pMDI on small airways physiological parameters in COPD patients.

• IRAS ID

  26295

• Contact name

  Peter J Barnes

• Sponsor organisation

  Chiesi Farmaceutici SpA

• Eudract number

  2008-008656-16

• ISRCTN Number

  not issued

• Research summary

  COPD (chronic obstructive pulmonary disease) is a lung disease that involves the large and small airways. The purpose of this study is to obtain information regarding the effects of a drug product called formoterol, developed by Chiesi Farmaceutici, and determine whether it acts on large, small, or both sets of airways. This will be important to help our understanding of the treatment COPD. The product used in this study is formoterol fumarate and has already been studied in patients with COPD, showing it to be effective and well tolerated. Formoterol has been used for a number of years to treat the symptoms of COPD, a disease that affects the lungs causing difficulties in breathing. Formoterol, when inhaled, helps open up airways lasting approximately 12 hours and in this way is useful in the treatment of the difficulty in breathing. This study will evaluate the effect on the airways using non-invasive physiological markers involving easily performed breathing tests. Formoterol will be compared to a similar product, salmeterol, which is also used to open up the lung airways.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  09/H0707/70

• Date of REC Opinion

  5 Nov 2009

• REC opinion

  Further Information Favourable Opinion