E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute viral bronchiolitis (an infection of the lower airways) in infants under two years of age. This is usually caused by Respiratory Syncytial Virus (RSV). The diagnosis of viral bronchiolitis will be made clinically and infants must fulfil the following criteria: prolonged (wheezing) expiration, tachypnoe and dyspnoe, frequently leading to respiratory insufficienty. |
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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 |
The objective of this randomised, double-blind, placebo controlled study is to evaluate what effect different concentrations of hypertonic saline solution have on hospital stay in infants with viral bronchiolitis. The primary objective is the number of days of admission, including days after possible transfer to the Pediatric Intensive Care Unit (PICU) if there is need for mechanical ventilation. Infants are discharged from the study when they do not need supplemental oxygen, intravenous fluids or tube feeding during at least 12 hours. If the discharge criteria, as mentioned above, are reached, the study will be completed at that point. Even though the actual discharge from hospital can be postponed due to logistical or social reasons. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are the necessity for transfer to a Pediatric Intensive Care Unit (PICU), the duration of supplemental oxygen treatment and the necessity for supportive treatment such as tube feeding, antibiotic treatment or bronchus dilatation. It will also be studied what sorts of viruses are responsible for bronchiolitis (RSV, Influenza, Parainfluenza or Rhinovirus) and whether infants with these different viruses react differently to inhalation of hypertonic saline solution. Potential differences can result in subgroup-analysis.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Infants younger than 24 months admitted with a viral bronchiolitis (prolonged and/or wheezing exspiration, tachypnoe and dyspnoe), a Wang-score of two or more and without a positive reaction on Salbutamol inhalation are included, after informed parental consent. |
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E.4 | Principal exclusion criteria |
Exclusion criteria are: haemodynamically important congenital cardiac disease, chronic pre-existent respiratory disease, T-cell immunodeficienty and admission of the patient with a viral bronchiolitis not due to clinical reasons, for instance social problems. Infants who are treated with systemic corticosteroids will also be excluded from the study, as are infants suspected to have underlying asthma and/or allergy. This includes infants with eczema or food-allergy. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary end point is the time to discharge, including duration of the treatment following a possible transfer to a paediatric intensive care unit. Discharge is defined as the time from which no additional oxygen therapy is required (oxygen saturation in rest in room air > 95%) and / or no need for intravenous fluids or gastric tube feeding for at least 12 hours. These criteria apply even in cases where actual discharge from hospital is delayed for logistical or social reasons. |
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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 | 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 | No |
E.6.9 | Dose response | Yes |
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 | 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 | 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 | Yes |
E.8.2.3.1 | Comparator description |
different concentrations 2.93% as well as 5.85% of Natriumchloride. |
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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.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
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
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Infants can be included from August 2009 till April 2010. The trial will end when the last subject undergoing the trial is discharged from hospital. Should more than 20% of subjects be excluded from the study for medical reasons or as a result of side effects, or should any life threatening adverse effect occur, then the study will be prematurely aborted. |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |