EUCTR2004-000755-41-CZ进行中（未招募）1 期
A three-month, double-blind, double dummy, parallel group, controlled study comparing the efficacy and safety between 12 µg twice daily of Formoterol-HFA and 12 µg twice daily of Formoterol-DPI (Foradil/Aerolizer) in children with persistent asthma
Chiesi Farmaceurtici S.p.A0 个研究点目标入组 460 人开始时间: 2004年8月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 460
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
- •Boys and girls aged of 5 to 12 years inclusive and whose parents or guardians give written informed consent
- •Clinical diagnosis of persistent asthma
- •Patients on a stable dose of inhaled corticosteroids for at least one month before the screening visit and use of short-acting beta 2-agonists (SABAs) on at least two days in the week prior to screening and/or with clinical symptoms during at least two days (consecutive or not) in the week prior to screening visit.
- •The daily dose of inhaled corticosteroids should be in the following ranges:
- •- 100 - 400 µg of budesonide-DPI
- •- 100 - 500 µg of CFC-beclomethasone dipropionate
- •- 50 - 200 µg of HFA-ultrafine beclomethasone
- •-100 - 250 µg of fluticasone
- •Patients free of long-acting b2-agonists treatment (LABAs) at least for one month before the screening visit
- •FEV1 = or > 60% and = or < 90% of the predicted normal value.
- •A FEV1 reversibility = or > 12 % over baseline, after 15 minutes following inhalation of 200 µg of salbutamol
- •A cooperative attitude and ability to be trained in the proper use of a pMDI and DPI
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years)
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Having received an investigational drug within 2 months before the current study
- •Lacking the motor skills (co-ordination of actuation and inhalation)
- •Inability to perform outcome measurements optimally
- •Inability for patients/parents/guardians to fill in diary-cards
- •Potentially unreliable patients or patients with a history of noncompliance to medical therapy
- •Children whose parents/guardians don’t give written informed consent
- •History of malignancy or treatment for malignancy within 5 years
- •Significant medical condition or laboratory profile that might compromise patient safety, compliance, interfere with evaluation
- •Seasonal asthma or asthma occurring only during episodic exposure to an allergen or occupational chemical sensitizer
- •History of cystic fibrosis or bronchiectasis
- •Clinically significant cardiac, renal, neurological, hepatic, endocrine or any concomitant diseases which could interfere with the protocol according to investigator’s opinion
- •Vaccination with live-attenuated virus within one month of screening visit
- •Children with an abnormal QTc interval value defined as > 460 msec
- •FEV1 < 60 % or > 90 % of predicted normal value
- •A FEV1 reversibility < 12 % over baseline, after 15 minutes following inhalation of 200 µg of salbutamol
- •Hospitalization or acute asthma exacerbation in the 2 months preceding the screening visit
- •Respiratory tract infection, excluding sinusitis, in the month preceding the screening visit
- •Allergy to one component of medications used (formoterol fumarate, tetrafluoroethane-134a, anhydrous ethanol and hydrochloric acid and lactose).
- •History of side effects (intolerance) to any of the pMDI and DPI ingredients
- •Parenteral or oral corticosteroids in the previous 4 weeks (3 months for slow-release corticosteroids).
- •Any change in dose, schedule, formulation or product of inhaled corticosteroids, cromolyn sodium, nedocromil, antihistaminics, leukotriene antagonists within one month of screening visit.
- •Theophylline (except oral sustained-release theophylline).
- •Astemizole or terfenadine
- •Treatment with non-potassium sparing diuretics, beta-blocking drugs, quinidine, quinidine-like anti-arrythmics, tricyclic anti-depressants, fluoxetine or MAO inhibitors
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