A double-blind, double-dummy, randomized, placebo- and active-controlled, three-way crossover study to evaluate the effect of Budesonide/Formoterol Spiromax® 80/4.5 mcg Inhalation Powder and Symbicort® Turbohaler® 100/6 mcg on the short-term lower leg growth rate in prepubescent children with persistent asthma.

Teva Branded Pharmaceutical Products R&D, Inc.0 个研究点开始时间: 2010年7月5日最近更新: 2012年3月19日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Teva Branded Pharmaceutical Products R&D, Inc.

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 clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. Written informed consent signed and dated by both parents/guardians before conducting any study related procedure
•2. Male and female prepubescent (Tanner stage 1) subjects aged 6 to 11 years, inclusive at the SV
•3. Subjects must have a documented history and physician confirmed and documented diagnosis of asthma for at least 3 months before the SV
•4. Subjects must be currently using inhaled ß2-agonists or inhaled corticosteroids in doses of Budesonide DPI = 400 mcg or Budesonide MDI = 800 mcg daily or other ICS equipotent to these doses
•5. Documented normal growth development (height between 3- and 97-percentiles according to standard growth charts)
•6. Peak expiratory flow rate (PEF) and forced expiratory volume in 1 second (FEV1) is >80% of predicted values based on established values for individual subjects
•7. Demonstrated satisfactory technique in the use of Spiromax and Turbohaler devices at the SV as outlined in Appendices 2 and 3 (of the protocol)
•8. Willingness and ability to accurately complete subject diary with the assistance of their parents/guardians
•9. Parents or legal guardians are capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the Investigator, capable of giving informed consent and complying with all study requirements (e.g. visits, daily diary completion).
•RANDOMIZATION CRITERIA
•1. No occurrence of an upper or lower respiratory tract infection during the Run-In Period
•2. No asthma exacerbation, defined as any worsening of asthma requiring any treatment other than rescue medication. This includes requiring the use of systemic corticosteroids and/or emergency room visit or hospitalization
•3. Normal visual oropharyngeal exam at the randomization visit (V1)
•4. Subject continues to be in general good health, meeting the selection criteria.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

排除标准

•1. Subjects having entered puberty (Tanner stage >1)
•2. History of life-threatening asthma (an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures)
•3. A culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear within 3 days preceding the SV
•4. Febrile illness with temperature > 39°C for more than five consecutive days within seven days of the SV
•5. Major surgery requiring general anesthesia within seven days of the SV
•6. Any asthma exacerbation requiring oral corticosteroids within 3 months of the SV
•7. Hospitalization due to asthma twice or more within 12 months prior to the SV or within 3 months of the SV
•8. Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular disease, hepatic disease, renal disease, hematological disease, neurological disease, pulmonary disease (including but not limited to chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, bronchopulmonary dysplasia, or chronic obstructive pulmonary disease), immunologic disease, or malignancy
•9. Current or prior (i.e., in the 4 weeks preceding the SV) use of high-dose ICS (>220 mcg/day of fluticasone propionate or equivalent ICS) for routine control of asthma
•10. Continuous use of a long-acting ß2-agonist (inhaled or oral) for asthma symptoms
•11. Known or suspected sensitivity to budesonide, formoterol, or any of the constituents of the dry powder inhalers
•12. History of severe allergy to milk proteins
•13. Clinical evidence of oral candidiasis at the SV
•14. History or current presence of glaucoma or posterior subcapsular cataracts
•15. Non-vaccinated or active infection with chickenpox or measles
•16. Administration of systemic, oral, or depot corticosteroids within 12 weeks of the SV
•17. Use of any oral or inhaled or injected asthma medication within 1 week of the SV (e.g., anticholinergics, cromolyn or nedocromil, theophylline compounds, except for study defined inhaled corticosteroids and inhaled short acting ß2-agonists
•18. Treatment with any known potent CYP3A4 inhibitors within 4 weeks preceding the SV (e.g., ritonavir, ketoconazole, itraconzole)
•19. Use of any medications that could affect the course of asthma, growth rate, or interact with study medications (e.g., anticonvulsants, ß-adrenergic blockers, intranasal steroids, and topical steroids)
•20. Parent or legal guardian has an infirmity, disability, or geographical location which may impair study compliance (e.g., completion of daily diary, non-availability for study visits/procedures, non-compliance with study medication)
•21. Participation in an investigational drug trial during 30 days preceding the SV
•22. Subject is an immediate family member of the participating Investigator, sub-Investigator, study coordinator, or employee of the participating Investigator.

研究者

发起方

Teva Branded Pharmaceutical Products R&D, Inc.

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