The Dose-Response, Safety and Efficacy of EP-101 in Subjects with COPD

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Seven Arm, Four-Period Cross-over, Incomplete Block Design, 7-Day Dosing Study to Assess the Dose-Response, Safety, and Efficacy of EP-101 in Subjects with Moderate to Severe COPD

• IRAS ID

  80476

• Contact name

  D Singh

• Sponsor organisation

  Elevation Pharmaceuticals, Inc.

• Eudract number

  2011-001810-32

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  Not Known

• Research summary

  The purpose of this study is to find out the safety and effects in the body when a drug EP-101 is given to subjects with COPD (Chronic Obstructive Pulmonary Disease) using a high efficiency nebuliser (PARI eFlow nebuliser). COPD is a lung condition.The active ingredient in EP-101, glycopyrrolate, 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 is being tested to see if it has a bronchodilator effect (i.e. if 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). The study treatments are as follows:- EP-101 placebo (once daily)- EP-101 25æg (once daily)- EP-101 50æg (once daily)- EP-101 100æg (once daily)- EP-101 200æg (once daily)- Tiotropium bromide 18æg (once daily, open-label, via the Handihaler©)- Ipratropium bromide 500æg inhalation solution (three times-a-day, open-label, via a general purpose nebuliser)Each subject will randomly (by chance) receive 4 of the possible 7 study treatments Each treatment period will be separated by a wash-out of 7 ( 2) days. During each treatment period frequent evaluations will be carried out which include; physical examinations, blood sampling for pharmacokinetic evaluation (amount of study drug in the blood), lung function tests, ECG (heart tracings) and Vital Signs (Blood Pressure and Pulse).Approximately 133 subjects diagnosed with moderate to severe COPD will be enrolled into the study.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/NW/0402

• Date of REC Opinion

  23 Aug 2011

• REC opinion

  Further Information Favourable Opinion