Asthma MedDRA version: 16.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Seebri Breezhaler, Enurev Breezhaler and Tovanor Breezhaler
Product Name: glycopyrronium bromide
Product Code: NVA237B
Pharmaceutical Form: Inhalation powder, hard capsule
Pharmaceutical
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Written informed consent must be obtained before any assessment is performed; Male and female adult patients aged 18 to =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs, drugs of a similar class, or any component thereof: Muscarinic antagonist agents, sympathomimetic amines, lactose or any of the other excipients of the study drug, long and short acting beta-2 agonists, corticosteroids; Women of child-bearing potential; Resting QTcF = 450 ms (male) or = 460 ms (female) at Visit 101 (assessed by central reader) and at Visit 102 (assessed by investigator at the site); Patients with a body mass index (BMI) of more than 40 kg/m2; Patients who have clinically significant renal, cardiovascular (such as but not limited to unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, myocardial infarction, arrhythmia, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of the efficacy and safety of the study treatment; Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention (BPH patients who are stable on treatment can be considered); Patients who have had an asthma exacerbation that required either treatment with additional or increased dose of systemic corticosteroids for at least 3 days, or an emergency room visit, or hospital treatment, or intubation in the 6 weeks prior to screening; Patients who have smoked or inhaled tobacco products within the 6 month period prior to screening, or who have a smoking history of greater than 10 pack years (Note:10 pack years = 1 pack /day x 10 yrs., or ½ pack/day x 20 yrs.); 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 must have been so for at least 3 months prior to run-in, and must be expected to remain unchanged throughout the course of the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superiority of NVA237 50 µg o.d. compared to placebo in addition to background therapy with LABA/ ICS (= 800 µg/day of budesonide or equivalent) in terms of trough FEV1 (the mean of values 23h 15min and 23h 45min post dosing) after 26 weeks of treatment in patients with asthma, who are poorly controlled despite treatment with LABA/ICS (= 800 µg/day of budesonide or equivalent).;Secondary Objective: Key: Demonstrate superiority of NVA237 50 µg od compared to pbo in addition to background therapy with LABA/ ICS (= 800 µg/day of budesonide or equivalent) for: • Time to 1st moderate or severe asthma exacerbation (52wks treatment) • ACQ-7 - wk26 Secondary: Compare efficacy NVA237 50 µg o.d. to pbo in addition to background therapy with LABA/ ICS (= 800 µg/day of budesonide or equivalent) for: • AQLQ(S) - 52wks treatment • SGRQ - 52wks treatment • ACQ-7, ACQ-6, ACQ-5 - 52wks treatment • Peak FEV1, FEV1 AUC0-3h post-dose, and mean pre-dose FEV1 - 52wks treatment • Trough FEV1 - 52wks treatment • FEV1 & FVC - individual timepoints • Morning & evening mean PEF (e-diary) • Asthma symptoms measured (ACD e-diary) • Rescue medication (e-diary) • Rate of moderate/severe asthma exacerbations • Time to 1st severe asthma exacerbation, and rate of severe asthma exacerbations • Time to 1st asthma exacerbation of any severity and rate of asthma exacerbations of any severity;Primary end point(s): Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 26: Spirometry testing will be performed in accordance with American Thoracic Society standards. Trough FEV1 defined as the mean of two measurements at 23 hours 15 minutes and 23 hour 45 minutes post dosing.;Timepoint(s) of evaluation of this end point: week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time to First Moderate or Severe Asthma Exacerbation Over 52 Weeks of Treatment: Asthma exacerbations are considered to be moderate if treatment with rescue systemic corticosteroids for greater than or equal to 3 days as outpatient or less than or equal to 24 hour emergency room visit was required. Asthma exacerbations are considered severe if treatment with rescue systemic corticosteroids for greater than or equal to 3 days and hospitalization or emergency department visit greater than 24 hours were required or death due to asthma. The time to the first moderate or severe asthma exacerbation is the study day on which the patient experienced first moderate or severe asthma exacerbation. For detailed list see full protocol;Timepoint(s) of evaluation of this end point: 52 weeks | — |
Countries
Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Croatia, Estonia, Finland, Germany, Hungary, India, Ireland, Italy, Latvia, Lithuania, Mexico, Netherlands, Philippines, Portugal, Romania, Serbia, Slovakia, Slovenia, South Africa, Spain, Turkey, United Kingdom, United States, Vietnam
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma AG
Outcome results
None listed