PER-094-06已完成未知
A 12-Week Efficacy and Safety Study of Two Doses of Mometasone Furoate/Formoterol Combination Formulation Compared With Mometasone Furoate Monotherapy, in Persistent Asthmatics Previously Treated With High-Dose Inhaled Glucocorticosteroids
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
研究概览
简要总结
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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 at least 12 years of age, belong to any sex and race, and have a diagnosis of asthma of at least 12 months of evolution.
- •2. The subject must have been receiving a high dose of ICS for at least 12 weeks before Screening and have not used oral glucocorticoids within 30 days prior to Screening. Must have maintained a stable asthma treatment regimen at least 2 weeks before the Selection.
- •3. The subject must have suffered at least one severe exacerbation that required a cycle of oral glucocorticoids 2 to 12 months before the Selection.
- •4. If, at the physician´s discretion, the change in treatment for asthma that the subject is currently receiving does not entail any inherent harm.
- •5. To document the diagnosis of asthma, one of the following methods may be used: a) The subject must demonstrate an increase in absolute FEV1 of at least 12% and at least 200 mL within 15 minutes after administration of four inhalations of albuterol / salbutamol. b) The subject must demonstrate a PEF variability of more than 20%. c) The subject must demonstrate a diurnal variation of the PEF of more than 20%.
- •6. At the Screening Visit, the subject´s FEV1 should be ≥ 50% projected, when all restricted medications have been suspended during the appropriate intervals.
- •7. At the Start Visit, the subject´s FEV1 should be ≥ 50% and ≤ 85% projected, when all restricted medications have been suspended during the appropriate intervals.
- •8. Clinical analyzes performed at the Screening Visit must be within normal or clinically acceptable limits.
- •9. The subject must be willing to give written informed consent and be able to comply with dose and visit schedules.
- •9. Women of childbearing age should be using an adequate, medically acceptable method of contraception.
排除标准
- •1. Subject that demonstrates a change in the absolute FEV1 of> 20% at any time from the Selection Visit to the Start Visit.
- •2. Subject who needs to use more than eight inhalations per day of SABA via MDl or 2 or more nebulizations per day with SABA 2.5 mg in 2 consecutive days from the Selection Visit to the Start Visit.
- •3. Subject experiencing a decrease in peak morning or evening expiratory flow below the stability limit of the Selection Period on 2 consecutive days any before Randomization.
- •4. Subject experiencing any clinical deterioration of asthma whose outcome is emergency treatment, hospitalization for asthma, or treatment with additional medication for asthma excluded in the protocol.
- •5. The subject who has been treated in emergency services or admitted to the hospital for treatment of airway obstruction within the last 3 months.
- •6. The subject who has ever needed a respirator due to respiratory failure secondary to asthma.
- •7. The subject who has suffered an infection of the lower or upper respiratory tract within 2 weeks prior to the selection and start visits.
- •8. Smoker or ex-smoker subject who has smoked within the previous year or tanga a cumulative history of smoking of more than 10 pack-years or equivalent.
- •9. Subject with clinically significant alteration of vital signs.
- •10. Subject with evidence of clinically significant oropharyngeal candidiasis at onset or before, with or without treatment.
- •11. The subject with a clinically significant history of renal, hepatic, cardiovascular, metabolic, neurological, ophthalmological, hematological, respiratory, gastrointestinal, cerebrovascular diseases or other significant medical conditions or disorders that require treatment that could interfere with the study.
- •12. Subject with known allergy or intolerance to glucocorticoids, B2 agonists, or to any of the inactive excipients present in the medications used in the study.
- •13. Woman who is breastfeeding, pregnant, or plans to become pregnant while participating in the study.
- •14. Subject known to use illicit drugs.
- •15. Subject known to be HIV positive.
- •16. Subject unable to correctly use an oral metered dose inhaler.
- •17. The subject who has been taking any of the restricted medications before the Selection without complying with the required pharmacological washing periods.
- •18. The subject who can not comply with the provisions on permitted concomitant medications and prohibited medications.
- •19. No subject participating in this study may participate in the same study in another research center.
- •20. The subject should not be randomized in this study more than once.
- •21. No person directly related to the administration of this study may participate as a subject of the study. No family member of the research study staff will be able to participate in this study.
- •22. Subjects who have previously participated in a study with SCH 418131.
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