Indacaterol 150mcg o.d vs tiotropium 18mcg o.d in COPD

• Research type

  Research Study

• Full title

  A phase IIIb multicenter, 52 week treatment, randomized, blinded, double dummy, parallel group efficacy study comparing the effect of inhaled indacaterol 150 mcg o.d. vs inhaled tiotropium 18 mcg o.d. on lung function, rate of exacerbations and related outcomes in patients with COPD

• IRAS ID

  16038

• Contact name

  Amr Radwan

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2008-007944-33

• 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. Frequent COPD exacerbations (worsening) are associated with impaired related quality of life and more rapid decline in lung function. Indacaterol is a new inhaled treatment for Chronic Obstructive Pulmonary Disease (COPD). It is a long-acting B2-adrenerigic receptor agonist (LABA) intended for once daily treatment. Various inhaled B2-adrenergic receptor agonists are on the market and are widely used for treatment of COPD and asthma. Short-acting B2-agonists such as salbutamol are indicated for quick relief of COPD symptoms as required. The LABAs formoterol and salmeterol are recommended for regular twice daily use. There is currently no once daily B2-agonist on the market and increased duration of action and reduced side effect profile would represent an advance over the B2-agonists currently available. Data from earlier studies suggest that indacaterol is suitable for once daily dosing. Tiotropium (Spiriva) is a once daily inhaled anti-cholinergic used for the treatment of COPD. The purpose of the study is to show that indacaterol 150mcg once daily is better than or as good as tiotropium 18mcg once daily over a 52 week treatment period. This will be assessed by comparing the patients' abilities to breathe out when the level of drug is at its lowest (trough Forced Expiratory Volume 1 - FEV1 and rate of exacerbation (worsening symptoms) over 52 weeks.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  09/H0402/15

• Date of REC Opinion

  2 Mar 2009

• REC opinion

  Favourable Opinion