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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