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临床试验/PER-016-99
PER-016-99已完成未知

A RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY TO EVALUATE THE EFFECT OF THE ADDITION OF MONTELUKAST SODIUM OR SALMETEROL XINAFOATE TO INHALED FLUTICASONE IN ASTHMATIC ADULTS

MERCK SHARP & DOHME PERÚ S.R.L.,0 个研究点目标入组 0 人开始时间: 1999年10月29日最近更新:
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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

年龄范围
0 至 0（—）

入选标准

  • •a.Patient understands the study procedures and agrees to participate by signing the appropriate informed consent form.
  • •b.Patient is a male or female and at least 15 and not more than 65 years of age at Visit 1. Female patients of childbearing potential must demónstrate a b-hCG level consistent with a non-gravid State at randomization and agree to use appropriate contraceptives (oral or single barrier); beginning at least 7 days before Visit 1 and continuing at least 14 days after Visit 9 or discontinuation visit.
  • •c.Patient has been a regular user of inhaled corticosteroids at dosages for at least eight weeks before Visit 1 (Prestudy Visit).
  • •d.Patient fulfills all the following signs and symptoms of asthma by Visit 3:
  • •1) A consistent clinical history, at least one year in duration, of intermittent or persistent symptoms including, but not limited to dyspnea, wheezing, chest tightness, cough, or sputum production.
  • •2) A forced expiratory volume in one second (FEVi), while withholding P-agonist for at least six hours, of between 50% and 90% (inclusive) of the predicted valué on at least two occasions at Visits 1, 2 or 3.
  • •3) Evidence of reversible airway obstruction, as defíned by an increase in FEVi or peak expiratory flow rate of >12% (absolute value) of predicted, 20 to 30 minutes after inhaled p -agonist administration on at least one occasion at Visits 1, 2, 3 or within the previous 12 months.
  • •4) A predetermined level of daytime symptoms (bi-weekly score of at least 56) and beta-agonist use (average of at least one puff/day) as recorded during the two weeks between Visits 2 and 3.
  • •e.Patient´s present asthma treatment Includes only short-acting inhaled beta-agonists and inhaled corticosteroids at the prestudy visit.
  • •f.Patient is currently a nonsmoker and has been a nonsmoker for at least six months prior to Visit 1, with a smoking history of no more than twelve pack-years [i.e., one pack (20 cigarettes) per day for twelve years].
  • •g.Patient is judged to be in good, stable physical and mental health (except for his/her asthma) based on the medical history, physical examination, and routine laboratory data and appears able to successfully complete this trial.

排除标准

  • •a.Patient is under the age of legal consent and consent cannot be obtained from parent or guardián.
  • •b.Patient is, in the opinión of the investigator, mentally or legally incapacitated preventing informed consent from being obtained, or cannot read or comprehend written material.
  • •c.Patient is hospitalized.
  • •d.Patient is a female who is <8 weeks postpartum or is breast feeding an infant.
  • •e.Patient intends to move or to vacation away from home for periods of time that would preclude their participation in the study.
  • •f.Patient has undergone any major surgical procedure within four weeks of Visit 1.
  • •g.Patient has participated in a clinical trial involving an investigational or marketed drug within four weeks of Visit 1.
  • •h.Patient is currently a regular user or a recent past abuser (within the past five years), of alcohol or illicit drugs.
  • •i.Patient has, in addition to asthma, any active, acute or chronic pulmonary disorder documented by history or physical examination.
  • •j.Patient has been treated in an emergency room within one month or has been hospitalized for asthma within three months of Visit 1.
  • •k.Patient has unresolved symptoms and signs of an upper respiratory tract infection (URI) within three weeks of Visit 1 or during the run-in period.
  • •l.Patient has evidence of active, clinically significant sinus infection (if previously present, it must have resolved within one week of Visit 1).
  • •General Medical
  • •m.Patient has a recent history (within three months of study start) of a clinically significant psychiatric disorder other than mild depression (does not interfere with work or social activities).
  • •n.Patient has a history of an anaphyiactic allergic reaction related to administration of either a marketed or investigational dnig or is otherwise hypersensitive to inhaled p-agonist, inhaled or oral corticosteroid or their components.
  • •o.Patient has a clinically significant, active disease of the gastrointestinal, cardiovascular, hepatic, neurological, renal, genitourinary, or hematological systems, or has uncontrolled hypertension (>160/95).
  • •p.Patient has a history of any illness that would require treatment with an excluded medication, could be immediately Ufe threatening (ventricular arrhythmia, neoplasia, incompletely cured or treated in the last three months), ´brittle´ diabetes mellitus would pose restriction on participation or successful compietion of the study, or would pose an additional risk to the patient by administering the study drug.
  • •q.Patient has significant and unexplained abnormalities on Period I laboratory measurements.
  • •r.Patient is at least 40% over or under normal weight for height and body build (based upen the Metropolitan Life Insurance Co., Height and Weight Tables).
  • •Medications
  • •s.Patient has taken the following anti-asthma medication before Visit 1:
  • •1) Oral, intravenous, intramuscular, cutaneous or intra-articular corticosteroids within one month
  • •2) Cromolyn, nedocromil or leukotriene receptor antagonists within two weeks
  • •3) TheophyIIine within one week
  • •4) Oral or long acting inhaled beta-agonists or inhaled anticholinergic agents within two weeks
  • •5) Terfenadine, fexofenadine, loratadine or cetirizine within one week (astemizole within 3 months).
  • •t.Patient has taken any medication specifically excluded within 14 days of Vi

研究者

发起方
MERCK SHARP & DOHME PERÚ S.R.L.,

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