QVA in mod to severe COPD 6m study

• Research type

  Research Study

• Full title

  A 26 week treatment, multicentre, randomised, double-blind, parallel-group, placebo and active controlled (open label) study to assess the efficacy, safety and tolerability of QVA149 (110/50 µg q.d.) in patients with moderate to severe chronic obstructive pulmonary disease (COPD)

• IRAS ID

  58715

• Contact name

  Amr Radwan

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2009-017772-25

• ISRCTN Number

  No number provided

• Clinicaltrials.gov Identifier

  No number provided

• 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 adrenerigic 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 used in the UK. The purpose of this study is to provide important efficacy and safety data for QVA149 (110æg indacaterol/50æg glycopyrrolate) in patients with moderate to severe chronic obstructive pulmonary disease (GOLD 2008). Data obtained from the study is intended to be used to support the registration of QVA149 worldwide. The study will aim to recruit approximately 2138 adult outpatients, with 50 of these patients in the UK. Patients will be randomised into one of 5 treatment arms (QVA149, QAB149, NVA237, open label tiotropium or placebo)with a randomisation ratio 2:2:2:2:1.

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  10/H1107/52

• Date of REC Opinion

  15 Sep 2010

• REC opinion

  Further Information Favourable Opinion