Study to assess QVA149 in patients with moderate to severe COPD

• Research type

  Research Study

• Full title

  A multicenter, randomized, double-blind, placebocontrolled study, to assess the long term safety of 52 weeks treatment with QVA149 (110µg indacaterol / 50µg glycopyrrolate) in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD)

• IRAS ID

  46638

• Contact name

  Amr Radwan

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2009-013235-38

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Chronic Obstructive Pulmonary Disease (COPD) is a disease of progressive airflow obstruction with affects approximately 20% of chronic cigarette smokers. Frequent COPD exacerbations (worsening) are associated with impaired related quality of life and rapid decline in lung function. QVA149 is a new combination medicine that combines a licensed drug called Indacaterol with a new one called NVA237. Indacaterol is a long-acting B2 adrenergic agonist (LABA) intended for once daily treatment. NVA237 is a long acting muscarinic antagonist (LAMA), which is also inhaled once a day. As a combination, QVA149 will be delivered once a day via a Single Dose Dry Powder Inhaler (SDDPI). Currently there is no fixed dose combination of a LABA and LAMA. A combination of a short acting B2-adrenerigic agonist (SABA) and a short acting muscarinic antagonist (SAMA) is available for the treatment of COPD; however this is not routinely prescribed in the UK. The purpose of this study is to provide important long term safety data for QVA149 (110æg Indacaterol /50æg Glycopyrrolate) in patients with moderate to severe chronic obstructive pulmonary disease (as per the GOLD Guidelines 2008). Data obtained from the study is intended to be used to support the registration of QVA149 worldwide, and to satisfy regulatory authorities who require at least 100 patients to be exposed to study medication for a minimum of one year. The study will aim to recruit approximately 339 adult patients, with 60 of these patients in the UK. Patients will be randomised into the 2 treatment arms of the study, with a randomisation ratio 2:1, QVA149: Placebo and stratified according to smoking history.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  10/H0402/22

• Date of REC Opinion

  15 Apr 2010

• REC opinion

  Further Information Favourable Opinion