Viral Induced Paediatric Asthma (VIPA) II Study – Intervention Phase

• Research type

  Research Study

• Full title

  Viral Induced Paediatric Asthma (VIPA) II Study - Early proof of efficacy trial of IFN-ß in childhood asthma

• IRAS ID

  71361

• Contact name

  Graham Roberts

• Sponsor organisation

  Southampton University Hospital NHS Trust

• Eudract number

  2011-001842-13

• ISRCTN Number

  n/a

• Research summary

  Up to 80% of asthma attacks in children are caused by the common cold virus (rhinovirus). There are no effective therapies to prevent asthma attacks in children. Interferon beta is a protein produced by cells to fight viruses. Studies have shown that cells from the airways of asthmatic adult volunteers were less able to produce interferon beta when exposed to rhinovirus. This finding offers both a Mechanism which might explain the clinical observation, and a therapy (inhaled Interferon beta) to treat or prevent asthma attacks induced by rhinovirus. Initial results show that Interferon beta has the same potential function in cells from children. Studies already completed in Southampton have demonstrated good tolerance and safety of nebulised Interferon beta in adult non-asthmatic volunteers and in patients with controlled asthma. A study with adults with asthma, who receive nebulised Interferon beta when they catch a cold, is currently being conducted. In Our study involving children we aim to recruit 50 children aged 5-11 years with a history of asthma attacks caused by common colds. Participants will be reviewed as soon as upper respiratory tract infection symptoms begin to collect nasal washin's and throat swabs for virus detection, saliva and blood samples. Participants will be given a 14 day course of once-daily Interferon beta via a handheld nebuliser. We will record asthma symptoms and lung function to assess treatment effects in this early paediatric trial.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  11/SC/0173

• Date of REC Opinion

  19 Dec 2011

• REC opinion

  Further Information Favourable Opinion