EUCTR2013-004632-30-PL进行中（未招募）不适用
A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, 12-Week Clinical Study to Assess the Efficacy and Safety of 80 or 160 mcg/Day of Beclomethasone Dipropionate Delivered via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Pediatric Patients 4 Through 11 Years of Age with Persistent Asthma
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •a1. Severity of disease: The patient has persistent asthma, with a forced expiratory volume in 1 second (FEV1) 40% to 90% of the value predicted for age, height, and sex at screening visit (SV).
- •b1. Current asthma therapy: The patient is currently being treated with 1 of the following:
- •- a stable daily dosage of an inhaled corticosteroid (ICS) in the range of 88-176 mcg/day of fluticasone propionate (or equivalent) for a minimum of 4 weeks (28 days) before SV
- •- a stable daily dosage of non-corticosteroid therapy, including leukotriene modifiers, theophylline, chromones, or short-acting ß2-agonists [SABAs] alone or in combination for a minimum of 4 weeks (28 days) before SV. Patients taking non-corticosteroid therapy will also need to meet uncontrolled asthma criteria before randomization
- •- a daily dose of ICS plus a LABA (at a dose less than or equivalent to fluticasone propionate 100 mcg/salmeterol 50 mcg twice daily) may be allowed but the patient will be required to discontinue this therapy and start fluticasone propionate MDI (44 mcg, 2 inhalations twice daily, for a total daily dose of 176 mcg/day or equivalent for at least 7 days to no more than 30 days before SV
- •c2. Reversibility of disease: The patient has demonstrated at least 12% reversibility of FEV1 within 30 minutes after 2-4 inhalations of albuterol/salbutamol hydrofluoroalkane (HFA) MDI (90 mcg ex-actuator) or equivalent at SV or on retesting. Patients aged 4-5 years who fail reversibility of FEV1 must demonstrate at least 12% reversibility of PEF after 2-4 inhalations of albuterol/salbutamol HFA MDI (90 mcg ex-actuator) or equivalent using the handheld peak flow meter. Nebulized albuterol/salbutamol at a total dose of 2.5 mg may be used at the investigator’s discretion. Reversibility values of 11.50-11.99 will be rounded to 12. A documented historical reversibility, including expiratory flow loops, of at least 12% to a beta-agonist in the previous 12 months before SV is acceptable for patients treated with ICS at baseline. Historical data is not acceptable for patients on non-corticosteroid therapy.
- •d. Written informed consent must be signed and dated by parent/legal guardian and the written informed assent form must be signed and dated by the patient (as applicable, per local regulations) before any study-related procedures are conducted.
- •e1. The patient is a male or female patient 4 through 11 years of age, inclusive, when informed consent/assent is signed (screening or prescreening visit, as applicable).
- •f. Asthma diagnosis: The patient has a diagnosis of asthma as defined by the NIH. The asthma diagnosis has been present for a minimum of 3 months and has been stable (defined as no exacerbations and no changes in medication) for at least 30 days before SV.
- •g1. The patient is able to perform acceptable and repeatable spirometry consistent with the ATS/ERS 2005 criteria
- •h. The patient is able to perform peak expiratory flow (PEF) (with assistance from parents/guardians/caregivers, as needed) with a hand-held peak flow meter.
- •i. The patient is able to use (with assistance from parents/guardians/caregivers, as needed) an MDI device without a spacer device and a BAI device.
- •j. The patient is able to withhold (as judged by the investigator) his or her morning regimen of asthma medication (non-corticosteroid therapy, ICS, or study drug) and rescue medication (eg, albuterol/salbutamol hydrofluoroalkane [HFA] MDI [or equivalent]) for at least 6 hours before SV and the tre
排除标准
- •a. The patient has a history of life-threatening asthma, defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, or hypoxic seizures.
- •b. The patient is pregnant or lactating, or plans to become pregnant during the study period or for 30 days after the patient’s last study-related visit (for eligible patients only, if applicable). Any patient becoming pregnant during the study will be withdrawn from the study.
- •c. The patient has participated in any investigational drug study within the 30 days (starting at the final follow-up visit of that study) preceding SV (or prescreening visit, as applicable), or plans to participate in another investigational drug study at any time during this study.
- •d. The patient has previously participated in a beclomethasone dipropionate BAI study as a randomized patient.
- •e. The patient has a known hypersensitivity to any corticosteroid or any of the excipients in the study drug or rescue medication formulation.
- •f. The patient has been treated with any known strong cytochrome P450 (CYP) 3A4 inhibitors (eg, azole antifungals, ritonavir, clarithromycin) within 30 days before SV or plans to be treated with any strong CYP3A4 inhibitor during the study.
- •g. The patient has been treated with any of the prohibited medications during the prescribed (per protocol) washout periods before SV.
- •h. The patient has used tobacco products within the past year (eg, cigarettes, cigars, chewing tobacco, or pipe tobacco, as applicable).
- •i. The patient has a culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract (URI or LRI), sinus, or middle ear that has not resolved at least 2 weeks before SV.
- •j. The patient has a history of alcohol or drug abuse within 2 years preceding SV, as applicable.
- •k. The patient has had an asthma exacerbation requiring oral corticosteroids within 30 days before SV, or has had any hospitalization for asthma within 2 months before SV.
- •l. Initiation or dose escalation of immunotherapy (administered by any route) is planned during the study period. However, patients who initiated immunotherapy 90 days or more before the screening visit (SV) and have been on a stable (maintenance) dose for 30 days or more may be considered for inclusion.
- •m. The patient has used immunosuppressive medications within 4 weeks (28 days) before SV.
- •n. The patient is unable to tolerate or unwilling to comply with the required washout periods and withholding of all applicable medications.
- •o. The patient has untreated oral candidiasis at SV. Patients with clinical visual evidence of oral candidiasis who agree to receive treatment and comply with appropriate medical monitoring may enter the study.
- •p. The patient has a history of a positive test for human immunodeficiency virus (HIV), active hepatitis B virus, or hepatitis C infection.
- •q. The patient is an immediate relative of an employee of the clinical investigational center.
- •r. A member of the patient’s household is participating in the study at the same time. (However, after the enrolled patient completes or discontinues participation in the study, another patient from the same household may be screened.)
- •s1. The patient has a disease/condition that, in the medical judgment of the investigator, would put the patient at risk through participation or that could affect the efficacy or safety analysis if the disease/condition worsened during the study.
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