Treatment of asthma MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Product Name: MK-0633
Product Code: MK-0633, L-001330395
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: MK-0633
Other descriptive name: 4-(4-fluorophenyl)-7-[[5-(1S)-1-hydroxy-1-(triflu
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Objective 1: To demonstrate that MK-0633, compared with placebo, results in dose related improvement in FEV1 over the last 4 weeks of the 6-week active treatment period in patients aged 18 to 70 years with chronic asthma. Objective 2: To determine the dose-related safety and tolerability of MK-0633 over 6 weeks in patients aged 18 to 70 years with chronic asthma.;Secondary Objective: To demonstrate that MK-0633, compared with placebo, results in dose-related improvement in asthma symptoms scores (both daytime and nighttime) over the last 4 weeks (diary data collected at weeks 4, 5 and 6) of the 6-week active treatment period in patients aged 18 to 70 years with chronic asthma.;Primary end point(s): The primary efficacy endpoint for this study is prebronchodilator FEV1. | — |
Countries
Czech Republic, Hungary
Outcome results
None listed