E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
mild asthma and allergic rhinitis |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
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 |
1. To assess real-world effectiveness of Montelukast in Children (2 – 14 years) with asthma and allergic rhinitis.
2. To evaluate asthma-related medical resource use during 12 months following Montelukast and ICS treatment.
3. To establish a benchmark group using ICS treatment under usual circumstances to compare changes in effectiveness from baseline and track resource use.
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
a. Patients’ caregiver understands the study procedures and agrees to
participate by signing the appropriate informed consent form.
b. Patient is a male or female and between the ages of 2 and 14 years
(inclusive) at Visit 1.
c. Patients diagnosed with asthma, classified as mild persistent asthma
according to GINA guidelines at the time of inclusion.
d. Patients diagnosed with comorbid allergic rhinitis.
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E.4 | Principal exclusion criteria |
a. Prior treatment with high dose ICS (i.e., requires a dose higher than beclomethasone dipropionate 400 μg per day, or equivalent), other medications used in severe cases.
b. Patients with suspected rhino-sinusitis (i.e., fetid breathing, mucopurulent nasal discharge, post nasal drip, X-ray finding etc.)
c. Patients with cystic fibrosis, congenital heart disease.
d. Patients with Chinese medication use at inclusion.
e. Inappropriate patients with investigator judgment.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint will be Daytime Asthma Symptom Score at 12 weeks. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
At 2 weeks: Daily Rhinitis Symptom Score, Daytime Asthma Symptom Score
At 12 weeks: Daily Rhinitis Symptom Score, Daily Asthma Symptom Score, ‘as-needed’ Short acting β-agonist use, Overnight asthma symptoms score, frequency of asthma attacks and asthma exacerbations, the number of asthma free days, Global Asthma Assessment by Patient/Caregiver and by Physician, Global Allergic Rhinitis Assessment
by Patient/Caregiver and by Physician, Willingness to Continue Therapy, Adherence Rate.
At 12 months: Asthma-related medical resources use including SABA, CS, unscheduled office visits for asthma, emergency department visits, frequency of hospitalizations, assessment of OTC and alternative medication use, allergic rhinitis medication use.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At 2 weeks: Daily Rhinitis Symptom Score, Daytime Asthma Symptom Score
At 12 weeks: Daily Rhinitis Symptom Score, Daily Asthma Symptom Score, ‘as-needed’ Short acting β-agonist use, Overnight asthma symptoms score, frequency of asthma attacks and asthma exacerbations, the number of asthma free days, Global Asthma Assessment by Patient/Caregiver and by Physician, Global Allergic Rhinitis Assessment
by Patient/Caregiver and by Physician, Willingness to Continue Therapy, Adherence Rate.
At 12 months: Asthma-related medical resources use including SABA, CS, unscheduled office visits for asthma, emergency department visits, frequency of hospitalizations, assessment of OTC and alternative medication use, allergic rhinitis medication use.
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
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.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |