QVA cross over study in mod to sev COPD

• Research type

  Research Study

• Full title

  A multicentre, randomised, blinded, double-dummy, placebo-controlled, 3-period cross over study to evaluate the effect of QVA149 on patient reported dyspnea in moderate to severe chronic obstructive pulmonary disease (COPD), using tiotropium as an active control.

• IRAS ID

  81038

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2011-000229-63

• ISRCTN Number

  n/a

• Research summary

  Chronic Obstructive Pulmonary Disease (COPD) is a progressive disease of airflow obstruction which 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 Ç?2 -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 Ç?2-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 in participants with moderate to severe COPD to support the worldwide registration of QVA149. The participants will be asked to complete a questionnaire regarding their shortness of breath in terms of tasks, activities and effort at the beginning of the study and then after each of the 3 periods of study medication. The study will aim to recruit approximately 234 adult outpatients, with 36 of these from the UK. Participants will be randomly selected to receive the 3 study treatments (QVA149, tiotropium or placebo). The order in which the participants will receive the treatment will be unknown, but there are a possible 6 combinations. The participants will receive each study treatment for 6 weeks, with a washout of 2 weeks between each treatment period.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  11/SC/0275

• Date of REC Opinion

  7 Sep 2011

• REC opinion

  Further Information Favourable Opinion