Study to Investigate the Effects of an IMP on Patients with Asthma

• Research type

  Research Study

• Full title

  A randomized, partially-blinded, single-dose, 4-way cross-over study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally inhaled indacaterol maleate administered via the Concept1 device or as a PulmoSphere® formulation via the Simoon Device

• IRAS ID

  30719

• Contact name

  Brendan J Colgan

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2009-012600-48

• Research summary

  This study will involve the use of a new drug being developed as an inhaled medicine for the treatment of chronic obstructive pulmonary disease (COPD). It works by relaxing and opening the airways improving the passage of air into the lungs (bronchodilation) making it easier to breathe. Information available from studies conducted to date suggests that the new drug is an effective, once-daily bronchodilator that begins to work in the body quickly and continues to work over a 24-hour period. As there are currently no marketed once-daily treatments for COPD, such a medicine would be a significant treatment advance. This study will look at two different formulations of the new drug taken once-daily to find out if there are any differences between the two. The formulations are inhaled through different inhalation devices. One formulation has been tested in humans many times. The other has not been used in humans before (two dose levels of this formulation will be tested). Volunteers will be asked to inhale the study medicine 3 times and placebo (a dummy drug with no active ingredient inside) once over the course of the study. About 36 male and female patients with asthma will take part in this study at 4 centres in 3 countries (UK, Germany and Netherlands). Asthma patients are being enrolled into this study as they show a greater response to medicines that relax and open the airways compared to COPD patients. The first 18 volunteers enrolled will undergo pharmacokinetic (PK) assessments. The remaining volunteers will not. Volunteers will complete 4 treatment periods. There will be an interval of 14-17 days between doses for those volunteers undergoing the PK assessments; or 7-10 days for those who are not are not. The total maximum duration of the study (including pre- and post-study medical examination) will be approximately 77 days for the PK group and 56 days for the non-PK group.

• REC name

  HSC REC B

• REC reference

  09/NIR03/62

• Date of REC Opinion

  19 Nov 2009

• REC opinion

  Further Information Favourable Opinion