Cross-over study with NVA237 vs tiotropium in early morning symptoms
Research type
Research Study
Full title
Multicenter, randomized, blinded, two-period cross-over study to assess the effect of glycopyrronium bromide (44 µg QD) versus tiotropium (18 µg QD) on morning activities and pulmonary function in patients with moderate to severe COPD
IRAS ID
135909
Contact name
Anthony Gunstone
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2013-002483-84
Clinicaltrials.gov Identifier
Research summary
Chronic Obstructive Pulmonary Disease is a disease of progressive airflow obstruction which affects approximately 20% of chronic cigarette smokers. It is a major cause of poor health and death worldwide and contributes significantly
to health care costs and comorbidity.Tiotropium is the current standard of care for the maintenance therapy of moderate to severe COPD patients. However, some weaknesses of tiotropium are its 24h bronchodilator profile, showing some decreased activity in the before dosing hours, as well as a documented slow onset of action. Glycopyrronium is a LAMA currently approved by the European Medicines Agency (EMA) for the maintenance treatment of COPD patients. Both active drugs showed an equivalent efficacy and safety profile, but glycopyrronium appeared to have a faster onset of action versus tiotropium, with higher levels of bronchodilation in the four hours following administration of the drug in previous studies.
Both NVA237 and tiotropium are long acting muscarinic antagonists (LAMA) which are inhaled once daily. The trial is looking at the first hours after dosing and their impact on pulmonary function, COPD symptoms and ability to perform dailiy activities by the patient.
The study will last for up to 100 days for each patient including two 28 day treatment periods. The aim is to recruit 120 patients in 4 countries in Europe (UK, Germany, Italy and Spain). In the UK, the aim is that approximately 36 patients will be randomised across 6 different sites.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
13/YH/0401
Date of REC Opinion
6 Feb 2014
REC opinion
Further Information Favourable Opinion