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 | 8.1 |
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 |
In pediatric patients aged 2 to 5 years with episodic asthma Primary 1 To investigate the regimen-related efficacy of montelukast daily dosing and intermittent, episode-driven dosing compared with placebo in decreasing the number of asthma episodes culminating in asthma attack over a 1-year treatment period. |
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E.2.2 | Secondary objectives of the trial |
. Key Secondary 2 To investigate, over a 1-year treatment period, the regimen-related efficacy of montelukast daily dosing and intermittent, episode-driven dosing compared with placebo in improving a the respiratory symptoms daily average mean of wheeze and difficulty breathing assessed over 3 days prior to asthma attacks; or b the respiratory symptoms daily average mean of wheeze, difficulty breathing, interference with activity and cough assessed during the 12-day treatment period of asthma episodes; 3 To compare the regimen-related safety profile of montelukast daily dosing and intermittent, episode-driven dosing with placebo over the 1-year treatment period. Other Secondary 4 To investigate the regimen-related efficacy of montelukast daily dosing and intermittent, episode-driven dosing compared with placebo in improving the number of asthma attacks over the 1-year treatment period, the number of asthma episodes over the 1-year treatment period |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
a. Patient is a male or female between the ages of 2 years 24 months and 5 years 71 months inclusive. b. Parent/legal guardian agrees to the patient s participation in the study as indicated by parental/legal guardian signature on the consent form. The patient and parent/guardian are willing to comply with procedures, and both patient and parent/guardian are able to keep scheduled clinic visits. Note It is expected that the parent/guardian designated as the primary caregiver for the patient will remain the same throughout the study. Occasionally, circumstances may arise under which this is not possible. In such cases, an alternative caregiver may be designated at the discretion of the investigator in consultation with the Clinical Monitor. c. Patient has a history of episodic asthma symptoms such that in the 12 months prior to Visit 1, patient had at least 3, but not more than 6, episodes of asthma symptoms e.g., cough, wheeze, shortness of breath for approximately 3 days, each involving 946;-agonist treatment, AND one of these episodes occurred within 6 months of Visit 1, AND episodes are separated in time by periods without asthma symptoms may be obtained as verbal medical history from parent/guardian . d. In the 12 months prior to Visit 1, patient had at least 1 corticosteroid treatment oral, rectal, or inhaled OR was hospitalized for asthma at least 1 time may be obtained as verbal medical history from parent/guardian . e. Patient is judged to be in otherwise good, stable health on the basis of medical history, physical examination and routine/baseline laboratory data, and appears to be able to successfully complete this trial. f. Parents/guardians are able to read and comprehend the questions in the diary. g. Patients can chew a tablet. |
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E.4 | Principal exclusion criteria |
a. Parent/guardian is, in the opinion of the investigator, mentally or legally incapacitated, thereby preventing informed consent. b. Patient is hospitalized. c. Patient has participated in a clinical trial involving an investigational or marketed drug within 8 weeks of Visit 1. d. Patient has had any major surgical procedure within 4 weeks of Visit 1. e. Patient has any clinically significant, active disease of the gastrointestinal, cardiovascular, hepatic, neurological, renal, genitourinary or hematological systems, or has hypertension. f. Patient has a history of any clinically significant adverse experience of a serious nature related to administration of either a marketed or investigational drug e.g., angioedema, anaphylaxis or is otherwise sensitive to marketed or investigational drugs. g. Patient has significant or unexplained abnormalities on the Visit 1 physical examination. Respiratory h. Patient has a history of persistent asthma symptoms such that daytime symptoms occur 1 time per week and nighttime symptoms occur 2 times per month. i. Patient has any active acute or chronic pulmonary disorder, other than asthma, documented by history or physical examination. j. Patient has required intubation for asthma in the past. k. Patient has any unresolved signs or symptoms of an acute asthma episode in the past 2 weeks. l. Patient has any signs or symptoms of a respiratory tract infection in the past 2 weeks. m. Patient has any evidence of active, clinically significant sinus disease in the past 4 weeks. Medication n. Patient is on immunotherapy. o. Patient has used any long-term controller medications inhaled corticosteroids, leukotriene modifiers, cromolyn/nedocromil or theophylline in the past 2 weeks or for 61619;4 months, cumulatively, in the 12 months prior to Visit 1. Procedural p. Patient is in a situation or has a condition which, in the investigator s opinion, may interfere with optimal participation in the study. q. Patient and parent/guardian are unable or unwilling to comply with study procedures, including adequate data entry into the diary and medication compliance. Exclusion Criteria at Visit 2 r. Patient has significant or unexplained abnormalities on the laboratory safety tests Appendix 2 . s. Patient and parent/guardian are unable or unwilling to comply with study procedures as determined during Period I, including adequate data entry into the diary and medication compliance. Exclusion Criterion at Visit 3 t. Patient and parent/guardian are unable or unwilling to comply with study procedures as determined during Period I, including adequate data entry into the diary and medication compliance. |
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E.5 End points |
E.5.1 | Primary end point(s) |
number of astmatic episodes in one year treatment |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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.8.5 | The trial involves multiple Member States | Yes |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 2 |