A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group, Dose-Ranging Study of MK-0633 in Adult Patients with Chronic Asthma - MK-0633 Asthma Dose-Ranging Phase IIb study

Merck & Co., Inc.0 个研究点目标入组 828 人开始时间: 2008年8月21日最近更新: 2019年11月25日

适应症

试验速览

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•Patient has a consistent clinical history, for at least 1 year, of symptoms of chronic asthma that may include, but are not limited to, dyspnea, wheezing, chest tightness, cough, and/or sputum production; While withholding short-acting ß-agonists for at least 6 hours and LABAs for at least 14 hours (withholding LABAs for 12-14 hours is acceptable, but not preferred), patient has a FEV1 =45% and =85% of the predicted value, documented at least once during Visits 1 or 2; While withholding short-acting ß-agonists for at least 6 hours and LABAs for at least 14 hours (withholding LABAs for 12-14 hours is acceptable, but not preferred), patient has evidence of reversibility of airway obstruction defined as an increase of FEV1 of 12% or greater 20 to 30 minutes after ß-agonist administration, documented at least once during Visit 1 or 2; Patient has a daytime and nighttime ß-agonist administration average =1 puff per day, as recorded on the patient’s diary card between Visits 2 and 3.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Patient has evidence of another clinically significant, active pulmonary disorder such as bronchiectasis or COPD documented by history, physical examination, or chest x-ray; Patient has a clinically unstable disease of the ophthalmologic, neurological, hepatic, renal, connective tissue, genitourinary, gastrointestinal, cardiovascular or hematologic systems.; Patient has any of the following abnormalities on screening (Visit 1) laboratory studies:Impaired renal function defined as creatinine =1.5 mg/dL; or Hemoglobin <11 g/dL; or WBC count <3000/mm3 ; or Platelet count <100,000/mm3; or Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) levels >1.5 times the upper limits of normal (ULN). Note: One retest will be allowed for patients at Visit 1 with: ALT and/or AST >1.5 x ULN and =2 x ULN.; Patient is unable to comply with the study procedures or protocol, including completion of the diary card and compliance with study medication.; Patient is unable to perform acceptable, reproducible spirometry; Patient has required an oral corticosteroid rescue for worsening asthma between Visit 1 and Visit 2 or between Visit 2 and Visit 3.

发起方