E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003553 |
E.1.2 | Term | Asthma |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 β-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 β-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 β-agonist administration, documented at least once during Visit 1 or 2; Patient has a daytime and nighttime β-agonist administration average ≥1 puff per day, as recorded on the patient’s diary card between Visits 2 and 3. |
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E.4 | Principal 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 <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.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint for this study is prebronchodilator FEV1.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 85 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |