PER-049-05已完成未知
Comparative Study of the Effect of Two Doses of Mometasone Furoate Dry Powder Inhaler 200 mcg and 400 mcg QD PM, Fluticasone Propionate 250 mcg BID, and Montelukast 10 mg QD PM, on Bone Mineral Density in Adults With Asthma
试验速览
- 阶段
- 未知
- 状态
- 已完成
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
- 年龄范围
- 0 至 0（—）
入选标准
- •1. The subject must be willing to give written informed consent.
- •2. The subject must agree to inform his or her attending physician of his participation in the study.
- •3. The subject must be a woman between 18 and 40 years of age or a male between 18 and 50 years of age, of any race.
- •4. The subject must have had asthma for at least 3 months.
- •5. The subject should never have been treated with an ICS to control asthma, or should not have taken ICS for at least the last 3 months.
- •6. The subject should have a pre-bronchodilator FEV1> 60% and <90% predicted.
- •7. Prior to randomization, the subject should have an increase in absolute FEV1> 12%, with an absolute increase in volume of at least 200 ml, after the reversibility tests.
- •8. Years of clinical laboratory tests (complete blood count, blood chemistry, urinalysis) must be within normal or acceptable limits.
- •9. The subject must have a level of 25-hydroxyvitamin D> 15 ng / ml.
- •10. The subject must be free of any clinically relevant disease.
- •11. Non-pregnant women of childbearing age should use a method
- •adequate, medically acceptable contraception.
- •12. The subject must have two valid densitometries, confirmed by the local DXA center.
排除标准
- •1. The subject requires the use of> 12 inhalations per day of salbutamol on 2 consecutive days.
- •2. The subject has an increase or decrease in FEV1 greater than or equal to 20% between the Screening and Baseline visits.
- •3. The subject was treated with methotrexate, cyclosporine, gold or another cytotoxic agent to control asthma or for a concomitant condition within the last 3 months.
- •4. The subject has a history of tobacco use in pipe or cigar.
- •5. The subject is a smoker or ex-smoker and smoked during the last year or has a history of cumulative smoking of more than 10 packs per year.
- •6. The subject experienced an infection of the upper or lower respiratory tract within the last 2 weeks.
- •7. The subject required more than 7 days of oral steroid treatments on 2 occasions within the last 12 months, or required an acute administration of systemic steroids in the last month.
- •8. The subject once required the help of a respirator due to respiratory failure secondary to asthma.
- •9. The subject was treated in an emergency department due to a clinical exacerbation of asthma (CAE), or hospitalized for the treatment of an airway obstruction on one occasion in the last 3 months or two or more occasions in the last 6 months.
- •10. The subject presents clinical signs of chronic bronchitis, bronchiectasis, emphysema or cystic fibrosis.
- •11. The subject participated in a research study in the last 30 days.
- •12. It is known that the subject is allergic or has intolerance to the ICS, beta agonists or drugs used in this study or to any of the excipients.
- •13. The average of two densitometries of the lumbar spine in the Selection presents more than 2 standard deviations (SD) below the normal of the young adult.
- •14. Any condition existing at the beginning that may affect
- •considerably the ability of the subject to wander normally.
- •15. Subject has a history of clinically relevant renal, hepatic, cardiovascular, metabolic, neurological, hematological, respiratory, digestive, cerebrovascular diseases or disorders or any other clinically relevant disease or disorder.
- •16. The subject was treated within the last year with medication known to interfere with bone metabolism.
- •17. Subject has a history and / or presents infraocular pressure> 22 mm Hg in one of the two eyes, glaucoma and / or posterior subcapsular cataracts.
- •18. Pregnant, breast-feeding, pre-menopausal women or
- •postmenopausal (by natural or surgical).
- •19. The subject presents a clinically relevant abnormal baseline vital sign.
- •20. The subject´s body mass index (BMI) exceeds 35 kg / m2.
- •21. It is known that the subject is HIV positive.
- •22. It is known that the subject is an alcoholic or a drug addict.
- •23. Subject shows signs of oropharyngeal candidiasis.
- •24. The subject´s normal sleep / wake cycle is reversed.
研究者
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