RELIEF-1

• Research type

  Research Study

• Full title

  A prospective, multicenter, single-arm study evaluating the safety and feasibility of Targeted Lung Denervation for the treatment of severe uncontrolled asthma.

• IRAS ID

  222622

• Contact name

  Pallav Shah

• Contact email

  pallav.shah@ic.ac.uk

• Sponsor organisation

  Holaira Inc.

• Clinicaltrials.gov Identifier

  NCT02872298

• Duration of Study in the UK

  4 years, 0 months, 0 days

• Research summary

  Is Targeted Lung Denervation (TLD) safe and feasible in the treatment of severe, uncontrolled asthma?
  Asthma affects over five million people in the UK today. Of these, a small proportion (less than 5%) have severe asthma that is difficult to control. Despite being a relatively small sub-group, these patients contribute to at least 50% of the total health care burden for this disease.
  Asthma can cause troublesome symptoms including breathlessness, wheeze and cough. These are caused in part by contraction of the smooth muscle lining the airways. This smooth muscle contraction is controlled by the vagus nerve. Currently we use inhaled medications such as tiotropium to help open up the airways by blocking the actions of the vagus nerve on the airways. This isn't effective for everyone, and means taking inhalers every day. Furthermore its effects can wear off during the course of the day. An operation to cut the vagus nerve improves lung function by stopping the nerve from causing contraction of airway muscle. However this is not routinely done as it is associated with significant risks and effects on other organs.
  The Holaira Targeted Lung Denervation (TLD) system is a minimally invasive way to cut or significantly reduce the connections of the vagus nerve that only supply the lungs. TLD has the potential to produce sustained improvements in lung function which are similar to the peak effects of inhalers such as tiotropium. This is a single-arm safety and feasibility study, so all eligible patients will undergo the treatment procedure, which involves a general anaesthetic and a lung camera test called a bronchoscopy. The primary outcome measure is the frequency of side-effects or adverse events requiring treatment, which are deemed to be related to the device and/or procedure. Patients will continue follow-up to three years.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  17/LO/0590

• Date of REC Opinion

  6 Jun 2017

• REC opinion

  Further Information Favourable Opinion