2025-524914-26-00招募中2 期
A Phase II, Randomized, Double-blind, 3-Period Cross-over, Dose‑ranging Study to Assess the Efficacy and Safety of Glycopyrronium (GP) versus Placebo in Participants of 4 to Less than 12 Years of Age with Asthma Receiving Background Budesonide and Formoterol Fumarate (BFF) (FAROS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 11
- 主要终点
- Change from baseline in FEV1 at 1 hour post-dose measured at EoT (at 3 weeks).
研究概览
简要总结
Evaluate the effect of 2 different GP MDI doses relative to placebo MDI as an add-on treatment to BFF MDI on lung function in 4 to less than 12 years old participants with asthma
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •[01] Participants must be 4 to less than 12 years (has not reached his/her twelfth birthday by the time of signing informed consent/assent).
- •[10] Parents/legal guardian willing and, in the opinion of the investigator, able to adjust current asthma therapy, as required by the protocol.
- •[11] Demonstrate acceptable MDI administration technique with spacer as judged by the investigator.
- •[12] Received no asthma medication other than run-in BFF MDI BID and albuterol/salbutamol as needed between Visits 1 and 2, except for allowed medications defined in the CSP.
- •[02] Participants who have a documented history of physician-diagnosed asthma at least 12 weeks prior to Visit 1, according to the latest GINA guidelines. Healthcare records ≥ 12 weeks prior to Visit 1 must be provided to ensure consistent evaluation and follow up of treatment in those participants.
- •[03] Participants who have been using a stable and regular ICS (160 to 400 μg/day budesonide or equivalent dose, see Appendix E) plus one additional asthma controller medication for at least 12 weeks with stable dose ≥ 1 month prior to Visit
- •[04] Participants must have a Childhood Asthma Control Test score ≥ 19 at Visit 1 and Visit
- •[05] Participants must have a pre-bronchodilator FEV1 ≤ 95% of predicted normal value at Screening Visit (Visit 1), and at Randomization visit (Visit 2). Note: If participants did not withhold asthma medication(s) according to the protocol-defined washout periods, the visit should be rescheduled within the next 5 days to perform spirometry. It would be up to investigator’s judgment whether participants showing FEV1 < 50% should be excluded due to safety concerns. Participants who failed spirometry testing at any visit due to quality or FEV1 being out of range may return to the clinic to repeat spirometry testing within 5 days. If repeat spirometry fails, then participants must be screen failed. If the Principal Investigator determines the quality of the spirometry at Visit 2 is unacceptable, the site must repeat the spirometry assessment within 5 days of Visit 2, prior to randomizing the participant.
- •[06] BMI ≤ 95 percentile for age and body weight of ≥ 14 kg or higher.
- •[07] Female participants who experience menarche must have a negative urine pregnancy test from Screening (Visit 1). Post-menarchal female participants must be informed of the need to prevent pregnancy during the study using effective contraceptive methods including total sexual abstinence, barrier method or hormonal contraception that can achieve a failure rate of less than 1% per year when used consistently and correctly.
- •[08] Participants provided assent to join the study, as applicable. The participant’s parent(s) or the LAR will sign the ICF. The LAR has to be 18 years or older. The parents/LAR must be capable of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- •[09] Parents/LAR must be willing and able to assist the child with the procedures outlined in the protocol, e.g., compliance with study medication.
排除标准
- •[01] Life-threatening asthma defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s) within the 12 months prior to Screening (Visit 1).
- •[10] Participants with a known hypersensitivity to beta 2-agonists, corticosteroids, anticholinergics, or any component of the MDI.
- •[11] Participants who are medically unable to withhold their short-acting bronchodilators and other asthma medications for the 6-hour period required prior to spirometry testing at each study visit.
- •[12] Any marketed (e.g., omalizumab, mepolizumab, benralizumab, reslizumab) or investigational biologic within 3 months or 5 half-lives of Screening (Visit 1), whichever is longer and must not be used during study duration.
- •[13] Regular use of a nebulizer or a home nebulizer for receiving asthma medications.
- •[14] Use of any immunomodulators or immunosuppressive medication within 3 months or 5 half-lives prior to Screening (Visit 1), whichever is longer, and must not be used during study duration, except for corticosteroids for asthma exacerbation management. Note: Topical administration of immunosuppressive medication may be allowed at the discretion of the investigator.
- •[15] Unable to abstain from protocol-defined prohibited medications prior to and during Screening and treatment periods.
- •[16] Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half-lives prior to Screening (Visit 1), whichever is longer.
- •[17] Participants with an eGFR ≤ 60 mL/minute/1.73 m2 using the Schwartz formula prior to Visit
- •[18] Planned hospitalization during the study.
- •[19] Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- •[02] Historical or current evidence of a clinically significant disease including, but not limited to cardiovascular, hepatic, renal, hematological, neurological, endocrine, gastrointestinal, or pulmonary (e.g., active tuberculosis, bronchiectasis, pulmonary eosinophilic syndromes). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the participant at risk through participation, or that could affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
- •[20] Judgment by the investigator that the participant should not participate in the study if the participant and/or the parent/guardian is unlikely to comply with study procedures, restrictions, and requirements.
- •[21] Previous enrollment in the present study.
- •[03] Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, vital signs, or ECG, which in the opinion of the investigator, may put the participant at risk because of his/her participation in the study, or that could affect the efficacy or safety analysis if the disease/condition exacerbated during the study. Note: Exclude participants with QTcF interval > 450 msec and participants with high degree atrioventricular block II or III, or with sinus node dysfunction with clinically significant pauses who do not have a pacemaker.
- •[04] Hospitalization for asthma within 8 weeks of Screening (Visit 1).
- •[05] Narrow-angle glaucoma not adequately treated and/or change in vision, bladder dysfunction, bladder outlet obstruction/urinary retention or any other conditions where anticholinergic treatment is contraindicated and may be relevant, in the opinion of the investigator, within 3 months of Screening (Visit 1).
- •[06] Use of LAMA, either alone or as part of an inhaled combination therapy, in the 12 weeks prior to Screening (Visit 1).
- •[07] Current use of any systemic beta-blockers. Note: All medications approved for control of intraocular pressures are allowed, including topical ophthalmic non-selective beta-blockers.
- •[08] Respiratory infection involving antibiotic treatment within 4 weeks prior to Screening (Visit 1) and during Screening/Run-in.
- •[09] Systemic corticosteroid use for any reason (including asthma exacerbations) within 4 weeks and intramuscular and depo injections within 12 weeks of Screening (Visit 1) and during Screening/Run-in.
研究组 & 干预措施
Placebo MDI
Placebo
干预措施: Placebo MDI (Drug)
null, null
Test
干预措施: null, null (Drug)
BFF (PT009)
Test
干预措施: BFF (PT009) (Drug)
结局指标
主要结局
Change from baseline in FEV1 at 1 hour post-dose measured at EoT (at 3 weeks).
Change from baseline in FEV1 at 1 hour post-dose measured at EoT (at 3 weeks).
次要结局
- Change from baseline in morning pre-dose trough FEV1 at EoT (at 3 weeks).
研究者
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (11)
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