The Safety, Efficacy and Pharmacokinetics of EP-101 in COPD Patients

• Research type

  Research Study

• Full title

  Randomized, Placebo-Controlled, Double-Blind, Dose Ranging, Single-Dose, 6-Way Crossover Study to Assess the Safety, Efficacy and Pharmacokinetics of EP-101 Using eFlow Nebulizer in Patients with COPD.

• IRAS ID

  46154

• Contact name

  Dave Singh

• Sponsor organisation

  Elevation Pharmaceuticals, Inc.

• Eudract number

  2010-018987-17

• Research summary

  The purpose of this study is to find out the safety and how it works in the body when a drug EP-101 is given to subjects with COPD (Chronic Obstructive Disease). COPD is a lung condition. EP-101 is already currently used before surgical operations as an injection to help dry up bronchial (windpipes) secretions and to reverse the side effects of some anaesthetic drugs and also given as an oral tablet to treat gastric ulcers. EP-101 also has a bronchodilator effect (i.e. it opens up the airways). This study looks at the effect this medication has on subjects given in the form of a liquid that is to be breathed in. To do this the drug is placed inside a device called a nebuliser (a commonly used device which turns a liquid into a fine mist that can be inhaled into the lungs where it can then be taken into the body). The study treatments are as follows: 1. EP-101 12.5 mcg/0.5 mL oral inhalation 2. EP-101 50 mcg/0.5 mL oral inhalation 3. EP-101 100 mcg/0.5 mL oral inhalation 4. EP-101 200 mcg/0.5 mL oral inhalation 5. EP-101 400 mcg/0.5 mL oral inhalation 6. Placebo 0.5 mL oral inhalation Each subject will receive all 6 study treatments as a single dose oral inhalation via the e-flow. Each treatment visit will be separated by a wash-out of 5-12 days. A total of 42 subjects with moderate to severe COPD will be enrolled. During each treatment period frequent procedures will be carried out which include, blood sampling, lung function tests, ECG (heart tracings ) and Vital Signs ( Blood Pressure and Pulse).

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/H1008/36

• Date of REC Opinion

  21 Jun 2010

• REC opinion

  Further Information Favourable Opinion