Safety, PK and Bronchodilatory Effects of GIS in COPD patients

• Research type

  Research Study

• Full title

  Single-Dose, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Bronchodilatory Effects of Glycopyrrolate Inhalation Solution (GIS) Using a High Efficiency Nebulizer in Patients with COPD

• IRAS ID

  18296

• Sponsor organisation

  Elevation Pharmaceuticals, Inc.

• Eudract number

  2009-010821-38

• ISRCTN Number

  1

• Research summary

  The purpose of this study is to find out the safety and how it works in the body when a drug called Glycopyrrolate is given to patients with COPD (Chronic Obstructive Pulmonary Disease). COPD is a lung condition. Glycopyrrolate is already currently used before surgical operations as an injection to help dry up bronchial (the windpipes leading to the lungs) secretions and as an oral tablet to treat gastric ulcer.This study looks at the effect this medication has on patients when given in the form of a liquid that is to be breathed in. To do this the liquid drug is placed inside a device called a nebuliser (a commonly used device which turns a liquid into a fine mist that can then be inhaled into the lungs where it can then be taken into the body). The nebuliser type to be used for Part 1 of the study will be a high efficiency nebuliser called an eFlow. A standard nebuliser will be used for Part 2 of the study.

• REC name

  Wales REC 2

• REC reference

  09/WSE02/20

• Date of REC Opinion

  16 Mar 2009

• REC opinion

  Favourable Opinion