Asthma
Conditions
Interventions
investigational material(s)
Generic name etc : NVA237 (glycopyrronium bromide)
INN of investigational material :
Therapeutic category code : 225 Bronchodilators
Dosage and Administration for Investig
Sponsors
Novartis Pharma K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * Male and female adult patients aged >= 18 or == 4 weeks * Pre-bronchodilator FEV1 of >= 50% and == 200 ml during reversibility testing
Exclusion criteria
Exclusion criteria: * Patients who have had an asthma exacerbation that required either treatment with systemic corticosteroids for at least 3 days, or an emergency room visit, or hospital treatment within 6 weeks prior to screening and patients with a history of life-threatening asthma attacks * Patients who have had a respiratory tract infection within 4 weeks prior to screening * Patients who have smoked or inhaled tobacco products within the past 6 month of screening * Patients with a history of chronic lung diseases other than asthma, including (but not limited to) chronic obstructive pulmonary disease, bronchiectasis, sarcoidosis, interstitial lung disease, cystic fibrosis, and tuberculosis (unless tuberculosis is confirmed as no longer active by imaging) * Patients on Maintenance Immunotherapy (desensitization) for allergies for at least 3 months prior to Run-in who are expected to change therapy throughout the course of the study * Patients who during the Run-in period are shown to be intolerable to LABA withdrawal * Patients who have discontinued LAMA therapy in the past (e.g. due to intolerance or perceived lack of efficacy) Other protocol defined inclusion/exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Trough FEV1 [ Time Frame: Following 1 week of treatment ] To evaluate the bronchodilator effects of NVA237 (25 microgram and 50 microgram) compared with placebo in terms of trough FEV1 (mean of 23h15min and 23h45min post -dose) following 1 week of treatment in the respective treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| FEV1 AUC [ Time Frame: Following 1 week of treatment ] To evaluate the bronchodilator effects of NVA237 (25 microgram and 50 microgram) compared with placebo in terms of Standardized FEV1 AUC following 1 week of treatment in the respective treatment period Peak FEV1 [ Time Frame: Following 1 week of treatment ] To evaluate the bronchodilator effects of NVA237 (25 microgram and 50 microgram) compared with placebo in terms of Peak FEV1 following 1 week of treatment in the respective treatment period FEV1 [ Time Frame: Following 1 week of treatment ] To evaluate the bronchodilator effects of NVA237 (25 microgram and 50 microgram) compared with placebo in terms of FEV1 following 1 week of treatment in the respective treatment period | — |
Outcome results
None listed