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 |
To determine the safety and tolerability of Captisol-Enabled Budesonide Inhalation Solution (CBIS) delivered via an electronic nebuliser (eFlow, PARI, Munich, Germany) in asthmatic children 5 to 12 years of age using clinical endpoints (heart rate and blood pressure), 10-hour overnight urinary creatinine-corrected cortisol, 8 am salivary cortisol, and adverse events (AEs) after two weeks exposure. To determine the local tolerability of CBIS using clinical symptoms (e.g., cough, stridor, dysphonia).
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E.2.2 | Secondary objectives of the trial |
To compare the efficacy of CBIS delivered via eFlow to conventional budesonide inhalation suspension (Pulmicort Respules) delivered via a general purpose nebuliser (LC Plus, PARI, Munich, Germany) using fractional exhaled nitric oxide (FeNO), clinical asthma symptoms and pulmonary function tests after twice daily treatments for 2 weeks. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male or female paediatric subjects who are steroid-requiring or steroid-free will be eligible for the study if they meet all of the following inclusion criteria: 1.Age 5 to 12 years, inclusive, at the Screening Visit. Note: Females, who may be of childbearing potential (menses have started), will have a urine pregnancy test at the beginning of the study 2.History of asthma for greater than or equal to 6 months prior to the Screening Visit as confirmed with clinical signs and symptoms. 3.For steroid-requiring subjects, the dose of inhaled steroid medication received prior to the Screening Visit must be less than or equal to 500 mcg/day beclomethasone dipropionate or equivalent. 4.History of FEV1 of > 60% of predicted normal values following appropriate withholding of inhaled beta-agonist and corticosteroid medication. 5. Negative pregnancy test (if of child bearing age) 6.Must otherwise be healthy as judged by general physical examination, medical history and routine clinical laboratory screening. 7.Provide written informed consent (parent or legal guardian) and, as appropriate, subject assent. 8.Willing and able to attend scheduled visits and complete the entire study. 9.Subjects on inhaled budesonide medication, must be willing to discontinue or replace current treatment.
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E.4 | Principal exclusion criteria |
Paediatric subjects will not be eligible for the study if they meet any of the following exclusion criteria: 1.History of life-threatening asthma, as defined in the GSAMP. This category includes those paediatric subjects with a history of near-fatal asthma requiring intubation or a hospitalisation or an Urgent Care Facility visit for asthma in the past year. 2.Current evidence or history of any clinically significant disease or abnormality. “Clinically significant” is defined as any disease that, in the opinion of the Investigator, would put the subject at risk through study participation, or which would affect the outcome of the study. 3.History of concomitant lung disease. 4.An upper or lower respiratory tract infection within 4 weeks prior to the Screening Visit. 5.Current evidence of oral candidiasis. 6.Current evidence or history of hypersensitivity or idiosyncratic reaction to inhaled budesonide. 7.Receipt of an investigational drug within 30 days of the Screening Visit. 8.Use of more than 12 puffs of Salbutamol per day.
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E.5 End points |
E.5.1 | Primary end point(s) |
1.Exhaled Nitric oxide 2.Clinical asthma scores (daytime asthma symptoms, nighttime awakenings, and rescue salbutamol use), 3.AM PEFR 4.Pulmonary Function Tests (FEV1, FEV25-75, FVC, FEV% predicted normal and PEFR) 5. Safety (Adverse events, urinary cortisol, vital signs and salivary cortisol). |
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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 | Yes |
E.7.1.3.1 | Other trial type description |
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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 | 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 | Yes |
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 | 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.8.9.1 | 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 | 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 |