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临床试验/PACTR202607586774191
PACTR202607586774191进行中（未招募）3 期

A double-dummy, double-blind, randomized, parallelgroup, active controlled study to evaluate the efficacy and safety of QVM149 (indacaterol acetate / glycopyrronium bromide / mometasone furoate) compared to salmeterol xinafoate/fluticasone propionate in children from 12 years to less than 18 years of age with asthma.

Novartis Pharma AG0 个研究点目标入组 32 人开始时间: 2026年7月8日最近更新:
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适应症

试验速览

阶段
3 期
状态
进行中（未招募）
入组人数
32
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
6 Year(s) 至 12 Year(s)（—）
性别
All

入选标准

  • •5.1 Inclusion criteria
  • •Participants eligible for inclusion in this study must meet all of the following criteria:
  • •Male and female adolescent subjects aged from = 12 years old to less than 18 years old at
  • •screening visit.
  • •Signed informed consent must be obtained prior to participation in the study. Written and
  • •signed informed consent by parent(s)/legal guardian(s) for the pediatric participant and assent by
  • •the pediatric participant (depending on local requirements) must be obtained before any
  • •study-specific assessment is performed.
  • •Patients with a documented diagnosis of persistent asthma (according to GINA 2022) for a period
  • •of at least 1 year prior to screening.
  • •Subjects who have used high dose ICS with LABA in combination for asthma for at least 3 months
  • •and at stable doses for at least 1 month prior to screening.
  • •Subjects must be symptomatic / inadequately controlled according to the investigator's opinion
  • •despite treatment with high stable doses of ICS with LABA in combination before screening.
  • •A history of one or more documented severe asthma exacerbations within the 12 months prior to
  • •screening that required either:
  • •Treatment with systemic corticosteroids (tablets, suspension or injection). OR
  • •Hospitalization (defined as an in subject stay or >24-hour stay in an observation area in the
  • •emergency room of other equivalent facility).
  • •NOTES: Investigators must use appropriate means to ensure the accuracy of the subject’s
  • •exacerbation history (subject history at screening documented in source notes, pharmacy records,
  • •hospital records, or chart records are acceptable).
  • •Subjects must have ACQ-5 score = 1.5 at end of run-in visit prior to randomization (prior
  • •to double-blind treatment) and qualify for treatment with high dose LABA/ICS/LAMA.
  • •Pre-bronchodilator FEV1 = 60 % and < 90 % of the predicted normal value for the subject
  • •according to ATS/ERS 2019 criteria after withholding bronchodilators (see Table 6-7) at both run-in
  • •and before randomization.
  • •Withholding/washout period of bronchodilators prior to spirometry:
  • •SABA for = 6 hours
  • •FDC or free combinations of ICS/LABA for = 48 hours
  • •Short acting anticholinergics (SAMA) for = 8 hours
  • •Xanthines = 7 days
  • •In case of combination ICS/LABA at screening, ICS alone should be continued until run-in
  • •Wash-out period of each drug should be adhered to as above and should not be longer. If wash-out
  • •period is considered to be longer please contact the Novartis Medical Monitor.
  • •A one-time repeat of percent predicted FEV1 (pre-bronchodilator FEV1) is allowed at
  • •run-in as well as before randomization. Repeat of run-in spirometry can be done later on the same
  • •day/visit (only to retest FEV1 criteria, not for reversibility, and before any salbutamol/albuterol
  • •inhalation) or in an ad-hoc visit to be scheduled on a later date (within 5 days of original
  • •run-in) that would provide sufficient time to receive confirmation from the spirometry data central
  • •reviewer of the validity of the assessment before randomization. Run-in medication can be dispensed
  • •at run-in visit however the dispensed medication should only be started by the patient if
  • •reversibility is met as per ATS/ERS criteria and if all other eligibility criteria as per protocol
  • •A one-time re-screen is allowed in case the subjects fail to meet the criteria at the repeat,
  • •provided the subjects return to t

排除标准

  • •5.2 Exclusion criteria
  • •Participants meeting any of the following criteria are not eligible for inclusion in this study.
  • •Subjects who have smoked or inhaled tobacco products within the 6 months period prior to
  • •screening, or who have a smoking history of greater than 10 pack years (Note:1 pack is equivalent
  • •to 20 cigarettes. 10 pack years = 1 pack /day x 10 yrs., or ½ pack/day x 20 yrs.) or use of
  • •nicotine inhalers such as e-cigarettes at the time of screening.
  • •Subjects who have had an asthma attack/exacerbation requiring systemic steroids OR
  • •hospitalization (> 24 hours) OR emergency room visit (= 24 hours) within 6 weeks of screening. If
  • •subjects experience an asthma attack/exacerbation requiring systemic steroids or emergency room
  • •visit between screening and end of run-in they may be re- screened 6 weeks after recovery from the
  • •exacerbation.
  • •Subjects who have ever required intubation for a severe asthma attack/exacerbation.
  • •Subjects who have a clinical condition which is likely to be worsened by ICS administration
  • •(e.g. glaucoma, cataract and fragility fractures) who are according to investigator's medical
  • •judgment at risk participating in the study. Subjects with narrow- angle glaucoma, bladder-neck
  • •obstruction or severe renal impairment or urinary retention.
  • •Subjects who have had a respiratory tract infection or asthma worsening as determined by
  • •investigator within 4 weeks prior to screening or between screening and end of run-in. Subjects may
  • •be re-screened 4 weeks after recovery from their respiratory tract infection or asthma worsening.
  • •Subjects with evidence upon visual inspection (laboratory culture is not required) of
  • •clinically significant (in the opinion of investigator) oropharyngeal candidiasis at end of run-in
  • •or earlier, with or without treatment. Subjects may be re-screened once their candidiasis has been
  • •treated and has resolved.
  • •Subjects with any chronic conditions affecting the upper respiratory tract (eg.
  • •Subjects with any chronic conditions affecting the upper respiratory tract (eg. chronic
  • •sinusitis) which in the opinion of the investigator may interfere with the study evaluation or
  • •optimal participation in the study.
  • •Subjects with a history of chronic lung diseases other than asthma, including (but not limited
  • •to) sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis
  • •and active tuberculosis.
  • •Subjects with type I diabetes or uncontrolled type II diabetes.
  • •Subjects who have a clinically significant laboratory abnormality before the end of run-in.
  • •Use of other investigational drugs within 30 days or 5 half-lives of enrollment, or until the
  • •expected pharmacodynamic effect has returned to baseline, whichever is longer.
  • •Subjects who, either in the judgment of the investigator or the responsible Novartis personnel,
  • •have a clinically significant condition such as (but not limited to) unstable ischemic heart
  • •disease, New York Heart Association (NYHA) Class III/IV left ventricular failure arrhythmia,
  • •uncontrolled hypertension, cerebrovascular disease, psychiatric disease, neuro-degenerative
  • •diseases or other neurological diseases, uncontrolled hypo- and hyper-thyroidism and other
  • •autoimmune diseases, hypokalemia, hyperadrenergic state, or ophthalmologic disorder or subjects
  • •with a medical condition that might compromise subject safety or compliance, interfere with

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