12 week treatment using NVA & Indacaterol in COPD

• Research type

  Research Study

• Full title

  A 12-week, multi-centre, randomised, double-blind, parallel-group study to assess the efficacy, safety and tolerability of the co-administration of NVA237 + indacaterol once daily vs. Indacaterol once daily in patients with moderate to severe COPD

• IRAS ID

  100114

• Contact name

  Amr Radwan

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2011-005673-23

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Chronic Obstructive Pulmonary Disease is a disease of progressive airflow obstruction which affects approximately 20% of chronic cigarette smokers. It is a major cause of poor health and death worldwide and contributes significantly to health care costs and comorbidity. Current treatment guidelines recommend the complementary use of one or more inhaled bronchodilators such as long-acting Ç?2-adrenergic receptor agonists [LABA] (e.g. salmeterol or indacaterol) and long-acting muscarinic receptor antagonists [LAMA] (e.g. tiotropium). These are established and widely-used treatments and may increase and sustain bronchodilation in patients with COPD. NVA237 is a long acting muscarinic antagonist (LAMA, which is inhaled once daily. Indacaterol is a licensed long acting Ç?2-adrenergic receptor agonist (LABA, which is also inhaled once daily).

• REC name

  London - City & East Research Ethics Committee

• REC reference

  12/LO/0550

• Date of REC Opinion

  8 Jun 2012

• REC opinion

  Further Information Favourable Opinion