Asthma MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Seebri Breezhaler
Product Name: Glycopyrronium bromide 44 µg (of active moiety delivered) or 50 µg(of active moiety in the capsule)
Product Code: NVA237
Pharmaceutical Form: Inhalation po
Sponsors
Novartis Pharma AG
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 44
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sarcoidosis, interstitial lung disease, cystic fibrosis, and tuberculosis (unless tuberculosis is confirmed as no longer active by imaging).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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the bronchodilator effects of NVA237 (25 ug and 50 ug) compared to placebo in terms of trough FEV1 (mean of 23h 15 min and 23 h 45 min post -dose) following 1 week of treatment in the respective treatment period ;Primary end point(s): Trough FEV1 (mL) after 1 week of treatment defined as the mean of the two FEV1 values measured at 23 h 15 min and 23 h 45 min post-dose. ;Timepoint(s) of evaluation of this end point: Day 7;Secondary Objective: To evaluate the bronchodilator effects of NVA237 (25 ug and 50 ug) compared with placebo: ? In terms of Standardized FEV1 AUC following 1 week of treatment in the respective treatment period ? In terms of Peak FEV1 following 1 week of treatment in the respective treatment period ? In terms of FEV1, FVC and FEV1/FVC ratio following 1 week of treatment in the respective treatment period ? In terms of Safety and tolerability in the respective treatment period (laboratory tests, vital signs, ECG and adverse events) ? As determined by patient diary data and electronic PEF meter in the respective treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Standardized AUC in FEV1 across different time intervals (5 min – 1 h, 5 min – 4 h, 5 min – 23 h 45 min) • Peak FEV1 during 5 min – 4 h. • FVC and FEV1/FVC at day 7 • PEF pre-dose morning and evening • Number of rescue puffs during the previous night and during the day;Timepoint(s) of evaluation of this end point: Day 7 | — |
Countries
Belgium, Germany, Japan, Latvia, Lithuania, United States
Contacts
Public ContactMedizinischer Infoservice (MCC)
Novartis Pharma GmbH
Outcome results
None listed