| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
|
| 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 |
|
| 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 compare breath patterns of organic volatile compounds detected detected by biosensors in healthy and asthmatic children; 2 to compare breath analysis with biosensors with measuremenet of exhaled nitric oxide, an independent noninvasive method for assessing lung inflammation; 3 to investigate the effect of montelukast Singulair 61650; and fluticasone Flixotide 61650; on breath patterns detected by biosensors in children with stable mild persistent asthma. |
|
| E.2.2 | Secondary objectives of the trial |
|
| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria |
| 1. Male or females children, aged 6 to 14 years, have atopic mild persistent asthma at step 2 of the Guidelines for the Diagnosis and Management of Asthma issued by the National Heart, Lung, and Blood Institute of the National Institute of Health as defined by a history of symptoms more than twice a week but less than daily step 2 . 2. Current asthma treatment includes short-acting inhaled 61538;-agonist alone as needed. 3. Positive skin prick testing. 4. Patient fulfills all the following signs and symptoms of asthma by visit 2 a History of symptoms including, but not limited to dyspnea, wheezing, chest tightness, cough, or sputum production for at least 12 months. b A forced expiratory volume in one second FEV1 of at least 80 of the predicted value pre-bronchodilator while withholding 61538;-agonist for at least six hours. This must be demonstrated twice at visits 1 and 2. c Patient has a diagnosis of asthma as defined by 1 an increase in FEV1 or PEF of 8805;12 absolute value , 20 to 30 minutes after inhaled 61538;-agonist administration at visits 1, OR 2 a positive methacholine PC20 provocative concentration causing a 20 fall in FEV1 of 8 mg/ml or lower which was performed within the previous 12 months, OR 3 a fall in FEV1 of at least 15 after an exercise challenge which was performed within the previous 12 months. 61538;-agonist reversibility and the methacholine and exercise challenge tests may be satisfied within the previous 12 months if there is adequate source documentation. 5. Patient is able to chew a tablet and inhale drug from a dry powder inhaler. 6. Patient is judged to be in good, stable physical and mental health except for his/her asthma based on the medical history, physical examination, and routine laboratory data, and appears able to successfully complete this trial. 7. Ability to perform reproducible spirometry. 8. Nonsmoker including no use of smokeless tobacco products in the past year for adolescents . 9. Ability of parent to provide informed consent, as evidenced by signing a copy of the consent form approved by the institutional review board of the subject s respective study institution, with assent from the child. |
|
| E.4 | Principal exclusion criteria |
| 1. Parent/legal guardian is, in the opinion of the investigator, mentally or legally incapacitated preventing informed consent from being obtained, or cannot read or comprehend written material. 2. Patient is hospitalized. 3. Patient has undergone any major surgical procedure within four weeks of visit 1. 4. Patient has, in addition to asthma, any active, acute or chronic pulmonary disorder documented by history or physical examination. 5. Patient has ever been intubated for asthma, has required acute asthma therapy treated in an emergency room/urgent care facility/office setting within one month or has been hospitalized for asthma within three months of visit 1 or required 2 or more hospitalizations for asthma in the past year. 6. Patient has FEV1 80 predicted on visit 1, nighttime awakenings from asthma 2 or more times per week, or PEF variability of 30 or more. 7. Patient received 4 or more oral corticosteroid bursts for asthma exacerbations in the past year. 8. Patient has unresolved symptoms and signs of an upper respiratory tract infection URI within three weeks of visit 1 or during the run-in period. 9. Patient has a history of an anaphylactic allergic reaction related to administration of either a marketed or investigational drug or is otherwise hypersensitive to inhaled 61538;-agonist or oral montelukast or inhaled fluticasone or their components. 10. Patient has a clinically significant, active disease of the gastrointestinal, cardiovascular, hepatic, neurological, renal, genitourinary, or hematological systems, or an immunodeficiency, or an autoimmune disorder. 11. Patient has a history of any illness that would require treatment with an excluded medication, could be immediately life threatening, would pose restriction on participation or successful completion of the study, or would pose an additional risk to the patient by administering the study drugs. 12. Patient has taken the following medications a Oral, intravenous, intramuscular, intra-articular or inhaled corticosteroids within 4 weeks of visit 1 with the exception of nasal corticosteroids administered on a continuous basis. b Leukotriene modifiers, theophylline derivatives, or mast cell stabilizers for asthma within 2 weeks before visit 1. c Received treatment within the previous 4 week with medications known to significantly interact with montelukast. d Antibiotics for 61502;7 consecutive days in the 4 weeks prior to visit 1. e IV gammaglobulin or immunosuppressants within one month of visit 1. 13. Patient has started immunotherapy within six months of visit 1. 14. Patient is unable or unwilling to comply with the study procedures as determined during the run-in period, including compliance with study medication. 15. Girls for whom onset of pregnancy during the study cannot be excluded. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| Concentrations of exhaled nitric oxide |
|
| 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 | Yes |
| E.6.4 | Safety | No |
| 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 | 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) | 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 | 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) | Yes |
| E.8.2.2 | Placebo | No |
| 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 | 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
| |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 0 |
| E.8.9.1 | In the Member State concerned days | |
| 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 |
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