Evaluation of the safety and efficacy of two doses of beclomethasone dipropionate - formulated with HFA (QVAR®), compared with placebo, supplied both in inhalers that are activated by breathing, and in metered dose inhalers and administered to children with asthma mild to moderate

IVAX RESEARCH, INC.,0 个研究点目标入组 0 人开始时间: 2005年10月10日最近更新: 2023年9月4日

试验速览

阶段: 未知
状态: 已完成
发起方

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

入选标准

•1. Children with an age between 5 and 11 years old.
•2. Documented clinical evidence of asthma for a minimum of six months and that has been stable for at least 30 days.
•3. The ability to perform an acceptable and reproducible spirometry.
•4. The ability to make the determinations of the PEF.
•5. Reversible bronchoconstriction.
•6. Children must be healthy, with a medical history
•clinically acceptable
•7. The parent or guardian must be willing to provide written informed consent.

排除标准

•1. The patient has used inhaled corticosteroids within the previous 30 days.
•2. The patient has allergy or sensitivity to BDP or other components of the formulations used in the MEC.
•3. The patient shows an increase or decrease in FEVi> 20% between the screening visit and the baseline.
•4. The patient is not willing to use an MDI without a spacer device.
•5. The patient requires using> 12 aspirations per day of albuterol for 3 consecutive days.
•6. There is evidence that the patient has growth retardation.
•7. The patient has been treated with methotrexate, cyclosporine, gold or other cytotoxic agents.
•8. The patient is receiving step doses of immunotherapy,
•oral immunotherapy or immunotherapy for short-course rhinitis.
•9. There is evidence that the patient has oropharyngeal candidiasis.
•10. The patient had exposure to investigational drugs within the previous 30 days.
•11. The patient requires continuous treatment with B-blockers, MAO inhibitors, tricyclic antidepressants, anticholinergics, inhaled cromoline or nedocromil, nebulizer therapy after the screening visit.
•12. The patient is unable to tolerate or unwilling to comply with the appropriate detoxification periods for all applicable medications.
•13. The patient has had treatment at some time for asthmatic episodes that have threatened the patient´s life.
•14. The patient has received any of the following treatments or has met any of the following conditions within the six weeks prior to the screening visit: Oral or injected corticosteroids, an upper respiratory tract infection and / or sinusitis associated with exacerbation of asthmatic symptoms, treatment in the emergency room or hospitalization due to asthmatic symptoms.
•15. History and / or presence of acute or chronic non-asthmatic lung disease.
•16. Presence of cardiovascular disease.
•17. History of glaucoma or cataracts.
•18. Presence of systemic infections by fungi, bacteria, parasites or a viral infection.
•19. Improbability to adhere to treatment.

研究者

发起方

IVAX RESEARCH, INC.,

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