Indacaterol 150mcg od vs tiotropium 18 mcg od in moderate-severe COPD

• Research type

  Research Study

• Full title

  A 12 week treatment,multi-centre, randomised, parallel group, blinded, double-dummy study to compare the effcacy and safty of Indacaterol (150 mcg o.d.) devlivered via a SDDPI with tiotropium (18 mcg o.d.) delivered via a HandiHaler® in patients with moderate to severe COPD.

• IRAS ID

  17831

• Sponsor organisation

  NOVARTIS Pharma Services AG

• Eudract number

  2009-010665-23

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Chronic Obstructive Pulmonary Disease (COPD) is a disease of progressive airflow obstruction which affects approximately 20% of chronic cigarette smokers. There is a high level of unmet medical need in the treatment of COPD patients, including effective symptomatic relief or treatment of dyspnea, limited exercise tolerance, mucus hypersecretion, cough and poor quality of life [GOLD Guidelines, 2007].Indacaterol maleate is a novel long acting inhaled B2-adrenergic receptor agonist intended for once daily treatment in patients with COPD or asthma (as part of a fixed dose combination with mometasone). Once daily treatment may provide an advantage over the currently marketed long acting inhaled B2-receptor agonists formoterol (Foradil©) and salmeterol (Serevent©) which are recommended for regular treatment twice daily in patients with COPD. Tiotropium is a long-acting, inhaled anticholinergic and is the currently the only approved once daily treatment for COPD.The safety, tolerability, pharmacokinetics and efficacy of inhaled indacaterol have been investigated in an extensive Phase I - III program, involving healthy subjects and patients with asthma or COPD, and following single and multiple doses (once a day for up to 52 weeks). The purpose of this study is to compare the efficacy and safety of indacaterol (150 æg o.d..) with tiotropium (18 æg o.d..) after 12 weeks (84 days) treatment. The data from this study will complement existing safety and efficacy data for indacaterol against other active treatments for COPD.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  09/H0402/52

• Date of REC Opinion

  2 Jun 2009

• REC opinion

  Further Information Favourable Opinion