A Phase II, Double-blind, Randomized, Multiple Dose, Cross Over, Three-treatment, Three-period, Six Sequence Placebo Controlled Trial to Evaluate Efficacy, Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety and Tolerability of Glycopyrronium (Bromide) in Children From 6 to Less Than 12 Years of Age With Asthma.

  • STATUS
    Recruiting
  • End date
    Feb 12, 2024
  • participants needed
    36
  • sponsor
    Novartis Pharmaceuticals
Updated on 22 October 2022

Summary

The purpose of this study is to characterize the bronchodilator effect, systemic exposure and safety/tolerability of two different doses of inhaled glycopyrronium, when compared to placebo. Outcome of this study will be used to determine the dose of inhaled glycopyrronium for the development of fixed dose combination indacaterol/mometasone/glycopyrronium (QVM149) for children aged 6 to less than 12 years old with moderate to severe asthma.

Description

The study design is a double-blind, placebo controlled, randomized sequence, three-treatment, three-period, six-sequence, cross-over multiple-dose study to evaluate efficacy, pharmacokinetics, pharmacodynamics, and safety and tolerability of glycopyrronium bromide (bromide) in children from 6 to less than 12 years of age with asthma with forced expiratory volume in one second (FEV1) ≥60% and ≤ 90% of the predicted normal value for the participant.

This study will consist of 4 phases: Screening, Run-in, Treatment and Follow-up.

After the screening phase, participants will enter the Run-in Phase to further assess eligibility and those participants that meet all eligibility criteria will be randomized. Study treatment will be administered in addition to background asthma LABA+ICS controller therapy (salmeterol xinafoate 50µg/fluticasone propionate 100µg) from entering the run-in period, through to the end of the treatment phase, including the 2 wash-out periods. Participants will be randomized to one of 6 different sequences with an equal (1:1:1:1:1:1) randomization ratio. The Treatment Phase will last 10 weeks, and every sequence is divided in three treatment periods: Glycopyrronium bromide 12.5 µg, Glycopyrronium bromide 25µg or matching placebo dry powder in capsules for inhalation, via Breezhaler. Each treatment period lasts 2 weeks and 2 consecutive treatment periods are separated by a 2-week wash-out period. Participants who discontinue their study treatment prematurely will be required to return to the clinic for an Early Termination Visit. 30 days after last treatment date, a final telephone contact must be conducted for safety follow-up.

The total duration of the trial for a participant (from screening to follow up) is approximately 20 weeks including safety follow-up.

Details
Condition Asthma
Treatment Placebo, Glycopyrronium bromide 25ug, Glycopyrronium bromide 12.5ug
Clinical Study IdentifierNCT05222529
SponsorNovartis Pharmaceuticals
Last Modified on22 October 2022

Eligibility

Yes No Not Sure

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-Diary entries 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

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 (Visit 1)
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
Additional protocol-defined inclusion / exclusion criteria may apply
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