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 25 µg of active moiety in the capsule
Product Code: NVA237
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN:
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Confirmed diagnosis of asthma for at least 6 months - Signed informed consent by parent(s)/legal guardian(s) and assent by the pediatric patient (depending on local requirements) - Patient on stable dose of inhaled low-to-medium dose ICS with one additional controller for at least 4 weeks prior to randomization - Pre-Bronchodilator FEV1 =60% to =90% of predicted normal at beginning of Run-in and randomization - FEV1 reversibility, done using up to 4 puffs of SABA (up to 400µg salbutamol or 360µg albuterol) at Run-in visit (Visit 20): increase > and/or = 12% (performed according to American Thoracic Society (ATS)/European Respiratory Society (ERS) 2019 guidelines). All patients must perform a reversibility test at start of Run-in. If reversibility is not demonstrated at Run-in, it may be repeated once on the same day. If reversibility is still not demonstrated after repeated assessment patients must be screen failed - Demonstrated acceptable inhaler use technique for Breezhaler and Diskus/Accuhaler prior to randomization, and able to complete spirometry procedures prior to randomization - A parent/legal guardian must be designated to complete all e-Diaryentries and attend all clinic visits with the patient - Parents/legal guardian must be willing and able to assist the child with the procedures outlined in the protocol, e.g. compliance with study medication, completion of electronic patient diary - Female patients of child-bearing potential, who might become sexually active, must be informed of the need to prevent pregnancy during the study using effective contraceptive methods. The decision on the contraceptive method should be reviewed at least every 3 months to evaluate the individual need and compatibility of the method chosen. Are the trial subjects under 18? yes Number of subjects for this age range: 42 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Systemic corticosteroid use for any reason within 3 months of Run-in - Patients on low to medium mono ICS alone-Patients requiring six or more puffs of rescue medication per day on more than two consecutive days in the four weeks prior to Screening (Visit 1) and/or in the four weeks prior to the Run-in visit-Patients who have had an asthma attack/exacerbation requiring a) systemic corticosteroids (SCS) or b) hospitalization or c) emergency room visit, within 3 months prior to Screening (Visit 1), or more than 3 separate exacerbations in the 12 months preceding the Screening visit-Patients with a known narrow-angle glaucoma, bladder dysfunction, bladder outlet obstruction or any other conditions where anticholinergic treatment is contraindicated prior to Screening (Visit 1)-Patients with a history of long QT syndrome or whose corrected QT interval (QTc) measured at start of Run-in and confirmed at Baseline (prior to randomization) (Fridericia method) is prolonged (> 450 msec for boys and girls) and confirmed by a central assessor (these patients should not be rescreened) - Suspected or documented active infections (bacterial, viral, fungal, mycobacterial or other, including active SARS-CoV-2, tuberculosis or atypical mycobacterial disease) of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 6 weeks of Screening (Visit1) - History of Type I diabetes or uncontrolled Type II diabetes - Patients who are sexually active at screening - Hemoglobin levels outside normal ranges at Run-in (Visit 20) - Female patients of childbearing potential (e.g., are menstruating) who do not agree to abstinence or, if they become sexually active during study participation, do not agree to the use of contraception as defined in the inclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the change from Baseline in trough forced expiratory volume in one second (FEV1) at week 2 of each treatment period ;Secondary Objective: ? To characterize systemic exposure following 2 doses of glycopyrronium (GLY) ? To evaluate the change from Baseline in peak expiratory flow (PEF) rate at week 2 of each treatment period ? To evaluate the change from Baseline in FEV1 at 30 min and 1 hour post dose at week 2 of each treatment period ? To evaluate the change from Baseline in rescue medication use over each treatment period ? To evaluate the safety and tolerability of each treatment, including in laboratory parameters including blood glucose and serum potassium ? To assess typical anti-muscarinic side effects (including dry mouth, fatigue, constipation and urinary retention) ;Primary end point(s): Change from Baseline in trough FEV1 at week 2 of each treatment period. ;Timepoint(s) of evaluation of this end point: Week 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Steady state PK parameters C0 will be provided for plasma glycopyrronium concentrations at pre-dose and post-dose time-points at the start and end of each 2 week treatment period. Systemic exposure following sparse PK sampling will be provided at pre-dose and post-dose time-points for each glycopyrronium dose level at the start and end of each 2 week treatment period. • Change from baseline in Morning and Evening PEF will be measured at the start and end of each 2 week treatment period. • Change from baseline in FEV1 will be measured at the start and end of each 2 week treatment period. • Change from baseline in rescue medication use will be recorded each morning and evening throughout the 2 week treatment by the participant using their electronic diary. • AESIs that are typical of anti-muscarinic agents will be assessed from the start of run-in to 30 days after end of treatment, up to maximum duration of 16 weeks. ;Timepoint(s) of evaluation of this end point: Week 2 | — |
Countries
Bulgaria, Colombia, Guatemala, Hungary, Poland, Russian Federation, South Africa, Spain, United Kingdom
Contacts
Public ContactPublic Information Desk
Novartis Hungary Kft.
Outcome results
None listed