TASMA: Targets of Bronchial Thermoplasty in Severe Asthma

• Research type

  Research Study

• Full title

  Unravelling Targets of Therapy in Bronchial Thermoplasty in Severe Asthma: TASMA study

• IRAS ID

  150245

• Contact name

  Pallav Shah

• Contact email

  pallav.shah@ic.ac.uk

• Sponsor organisation

  Academic Medical Center

• Duration of Study in the UK

  1 years, 1 months, 29 days

• Research summary

  5% of asthma patients suffer from severe asthma. Bronchial Thermoplasty(BT)is novel,innovative device-based treatment of severe asthma energy delivery in larger airways during bronchoscopy. Although proven effective on clinical outcomes in recent randomised trials, the mechanism of action for BT is largely unknown.

  After consent BT will be performed and patients will be randomised to either immediate or delayed BT-treatment group. The delayed BT group serves first as a control group BT for a 6 month period and then treated with BT. Off protocol follow-up of patients will be offered by standard follow-up procedures yearly after BT treatment for 5 years.

  Rationale: Approximately 5% of asthma patients suffer from severe asthma that is
  characterized by frequent asthma exacerbations resulting in significant morbidity and excessive utilisation of health care resources. Therefore, there is a strong need for improved therapeutic strategies for these patients. Insight in the pathogenesis and molecular pathways active in severe asthma is crucial to reach this goal. Bronchial Thermoplasty (BT) is a novel,innovative device-based treatment of severe asthma that is based on local, radiofrequent energy delivery in larger airways during bronchoscopy. Although proven effective on clinical outcomes in recent randomized trials, the mechanism that determines BT effective is largely
  unknown.
  Aim: To discover the molecular, cellular and structural airway targets of BT and link these to severe asthma phenotypes and clinical outcome.
  multicentre, interventional randomized controlled trial.
  A Mulit-Centre randomised Trial.After informed consent followed by standard BT screening, patients will be randomized to an
  immediate and delayed BT-treatment group. The delayed BT group serves first as a controlgroup in between BT and control group analyses (n=20/group) and second to increase the

  Study population: Severe asthma patients, who are symptomatic despite treatment with
  high dose inhaled corticosteroids, and fulfil the world health organization (WHO) or modified
  innovative medicines initiative (IMI) criteria of severe refractory asthma. .

• REC name

  London - City & East Research Ethics Committee

• REC reference

  15/LO/0005

• Date of REC Opinion

  25 May 2015

• REC opinion

  Further Information Favourable Opinion