Study to investigate the effect of a medication on patients with COPD

• Research type

  Research Study

• Full title

  A randomized, open-label, multicenter, two-period crossover study to evaluate the 24 hour bronchodilator profile of Tiotropium Bromide Respimat® administered once daily versus twice daily in patients with Chronic Obstructive Pulmonary Disease (COPD)

• IRAS ID

  11792

• Sponsor organisation

  Novartis

• Eudract number

  2008-006305-16

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The reason for this study is to find out how taking the medicine, tiotropium bromide rispimat© once daily in the morning (5 microgram) comparts to taking it twice daily (2.5 microgram in the morning and 2.5 microgram in the evening). Tiotropium bromide is a type of medicine called a bronchodilator. Bronchodilators work by relaxing the muscles around the airways helping to open the airways quickly and making breathing easier. Tiotropium bromide rispimat© is a solution for inhalation which is currently approved -on the market- (available for doctors to priscribe) in the European Union and is given via the rispimat© (soft mist) inhaler. The approved dose is 5 micrograms (two puffs of 2.5 micrograms) from the rispimat inhaled once daily, at the same time of the day.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  09/H0406/4

• Date of REC Opinion

  30 Jan 2009

• REC opinion

  Further Information Favourable Opinion