E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
children with recurrent respiratory symptoms) |
|
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 |
As good responsiveness to corticosteroids is a hallmark of asthma (1), this response is likely able to discriminate between asthmatic children and non-asthmatic subjects. So far, response to inhaled corticosteroids has not been used as a predictor of asthma in studies, although several international guidelines advocate a trial treatment with inhaled corticosteroids for a likely diagnosis of asthma in young children. This study can test whether such guideline advises hold in clinical practice. |
|
E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
The medical trial of this application is a sub-study. Below the overall aim of the study is stated:
title: Early diagnosis of asthma in young children by using non-invasive biomarkers of oxidative stress/airway inflammation, and early lung function measurements
date: 25-10-2006 (of protocol)
The overall aim of the study: is an early asthma diagnosis in young children by the use of non-invasive biomarkers of airway inflammation /oxidative stress in exhaled air, and early lung function measurements.
The key-objectives are: 1) Which non-invasive inflammatory biomarkers in exhaled air, or lung function indices (baseline airway resistance, response after a bronchodilator, or response after a 1-month treatment with an inhaled corticosteroid) can reliably predict asthma at an early age? 2) What are the differences in inflammatory biomarkers and lung function indices between asthmatic children and non-asthmatic subjects? What are the best predictors of an early asthma diagnosis? |
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E.3 | Principal inclusion criteria |
Children aged 2-3 years, with recurrent respiratory symptoms suggestive of astma; |
|
E.4 | Principal exclusion criteria |
mental retardation, cardiac abnormalities, congenital anomalies, other respiratory diseases, chronic inflammatory diseases (e.g. Morbus Crohn, rheumatoid arthritis), inability to perform the exhaled air and lungfunction procedures properly |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Effects of medication on: - Nitric oxide (NO) in exhaled breath - Breathogram of volatile substances in expired air - Exhaled breath condensate - Lungfunction measurements of airway resistance - Respiratory symptoms and quality of life |
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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 | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | Yes |
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) | 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 | No |
E.8.1.6 | Cross over | Yes |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
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
|
This is described in the protocol. |
|
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 |