PER-077-06已完成未知
RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SECURITY OF TWO DAILY DOSES OF THE GW685698X OF 200 MCG, A DAILY DOSE IN THE MORNING OF GW685698X 200 MCG AND 400 MCG, AND A DAILY DOSE BY THE NIGHT OF THE GW685698X OF 200 MCG AND 400 MCG, COMPARED WITH THE PLACEBO DURING 8 WEEKS IN ADOLESCENT AND ADULT SUBJECTS (FROM 12 YEARS TO OLDER) WITH PERSISTENT ASTHMA.
GLAXOSMITHKLINE PERU S.A.,0 个研究点目标入组 0 人开始时间: 2006年10月6日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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. Type of Patient: Ambulatory.
- •2. Age: 12 years of age or older at visit 1 (or ≥ 18 years of age or older if local regulations or the regulatory condition for study medication allows only adult patients to enroll).
- •3. Gender: Men or eligible women. Women are eligible to participate only if they are not gestating or breastfeeding. In order to be eligible to enter the study, women with the potential to have a family must commit to consistently and correctly using an acceptable method of birth control.
- •4. Diagnosis of Asthma.
- •5. Severity of the Disease: A better morning value (AM) of the forced expiratory volume in the first second (FEV1) between 50% and 80% of the value predicted during Visit 1.
- •6. Reversibility of the Disease: Reversibility ≥ 12% and 200 mL of FEV1 demonstrated within 30 minutes after administering 200 to 400 mcg of albuterol / salbutamol aerosol for inhalation in Visit 1.
- •7. Concurrent Therapy Against Asthma: Patients should be using an inhaled corticosteroid daily at least 3 months before Visit 1; and should be kept in a stable dose for 4 weeks before Visit 1.
- •8. Short Action Beta 2 Agonists: All patients should be able to replace the short-acting beta 2 agonists with albuterol / salbutamol spray for inhalation at Visit 1.
- •9. Informed Consent: All patients must be able and willing to give written informed consent to participate in the study.
- •10. Compliance: Patients must be able to meet all the requirements of the study.
排除标准
- •1. History of Potentially Lethal Asthma.
- •2. Asthma Medications: The following medications for asthma should not have been used prior to visit 1, at the intervals indicated below; and should not be taken during the study: A) Within the previous 24 hours: short-acting oral beta 2 agonists. B) Within the previous 2 weeks: a) Combination therapy containing beta 2 agonists and inhaled corticosteroids for asthma. b) Slow release bronchodilators. c) Anticholinergics. d) Long-acting beta 2 agonists. e) Ketotifen. f) Nedocromil sodium. g) Sodium cromoglycate. h) Long-acting oral beta-2 agonists. C) Within the previous 4 weeks: Anti-leukotrienes. D) Within the previous 12 weeks: a) Systemic corticosteroids. b) Anti-IgE.
- •3. Other Medications: Potent known inhibitors of the CYP3A4 system should not have been used.
- •4. Respiratory Infections: History of a respiratory tract infection within 4 weeks prior to Visit 1.
- •5. Exacerbations of Asthma: History of an asthma exacerbation within the previous 4 weeks, any exacerbation of asthma requiring corticosteroids administered orally within 3 months prior to Visit 1, or any hospitalization due to an exacerbation of asthma within 6 months prior to Visit 1.
- •6. Research Medication: A patient must not have used any investigational drug within 30 days prior to Visit 1 or within ten half lives (t 1/2) of the drug.
- •7. Abnormal Result in the Ultrasound Study of the Gallbladder: A patient should not have an abnormal result in the ultrasound study of the gallbladder in Visit 1 or a history of current gallbladder disease.
- •8. Diseases / Concurrent Abnormalities: Historical or current evidence of clinically significant and uncontrolled disease.
- •9. Oropharyngeal Examination: A patient will not be eligible for the introductory period if he / she had evidence of oropharyngeal candidiasis at Visit 1.
- •10. Drug Allergy: Any adverse reaction including immediate or delayed hypersensitivity to any beta 2 agonist, sympathomimetic drug, or any therapy with intranasal, inhalational or systemic corticosteroids.
- •11. Allergy to Milk Proteins: History of severe allergy to milk proteins.
- •12. Immunosuppressive medications: A patient should not be using or require the use of immunosuppressive medications during the study.
- •13. Attendance: A patient will not be eligible if he / she or his / her father or mother or legal representative has any illness, disability or if he / she lives in a geographic location that generates the probability of affecting compliance with any aspect of the protocol of the present study or with the scheduled visits. It also excludes from the participation in the study the presence of any neurological or psychiatric disease or a history of drug or alcohol abuse that could interfere with the appropriate compliance with the protocol requirements by the patient.
- •14. Use of tobacco: A patient must not have used tobacco products within the previous year and must not have had a historical use> 10 packs per year.
- •15. Affinity with the Researcher´s Headquarters: A patient will not be eligible if he or she is an immediate family member of the researcher, assistant researcher or coordinator of the participating study, or if he or she is an employee of the participating researcher.
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