long term safety of QVA149 (1yr study)

• Research type

  Research Study

• Full title

  A placebo and active controlled study to assess the long-term safety of once daily QVA149 for 52 weeks in Chronic Obstructive Pulmonary Disease (COPD) patients with moderate to severe airflow limitation

• IRAS ID

  109880

• Contact name

  Anzal Qurbain

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2012-002057-38

• ISRCTN Number

  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 adrenerigic agonist (LABA) intended for once daily treatment. NVA237 is a long-acting muscarinic antagonist (LAMA), which is also inhaled once a day. Currently there is no fixed dose combination of a LABA and LAMA and QVA149 will be delivered once a day via a Single Dose Dry Powder Inhaler (SDDPI). 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 airflow limitation. This study will provide long-term safety data comparing QVA149 with placebo and a standard of care treatment (tiotropium) in this group of patients. The study is designed to show that the non-inferiority of QVA149 compared to placebo in regards to the overall number of serious adverse events reported. Data obtained from the study is intended to be used to support the registration of QVA149 worldwide, and to satisfy regulatory authorities which require at least 100 patients to be exposed to study medication for a minimum of one year. The study will aim to recruit approximately 1224 adult patients, with 50 of these patients in the UK. Patients will be randomised into the 3 treatment arms of the study, with a randomisation ratio 1:1:1, QVA149:Tiotropium:placebo and stratified according to current smoking status, use of inhaled corticosteriods and airflow limitation

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  12/LO/1281

• Date of REC Opinion

  1 Oct 2012

• REC opinion

  Further Information Favourable Opinion