IgG Therapy for IgG Subclass 2 Deficient patients with bronchiectasis

  • Research type

    Research Study

  • Full title

    Immunoglobulin Replacement Therapy for Immunoglobulin G Subclass 2 Deficient Patients with Bronchiectasis- A Proof of Concept Study.

  • IRAS ID

    224704

  • Contact name

    Adam Hill

  • Contact email

    adam.hill318@nhs.net

  • Eudract number

    2017-002845-31

  • Clinicaltrials.gov Identifier

    TCS/16/60, Chief Scientists Office

  • Duration of Study in the UK

    3 years, 0 months, 0 days

  • Research summary

    Bronchiectasis is a common chronic lung condition with over 1,000 patients attending secondary care in NHS Lothian. Such patients have permanent airways damage leading to daily symptoms of cough, sputum production and recurrent respiratory tract infections. We have found a severe deficiency of the immune system as a rare cause of bronchiectasis (called immunoglobulin G subclass 2 deficiency) and occurs in about 1 in 20 bronchiectasis patients. Our pilot work shows these patients have more chest infections and their lung function deteriorates more rapidly. There are no trials to date to guide doctors to decide whether we should replace this deficiency from donated blood or not. The aim with treatment is to prevent disease progression and avoid the need for long term antibiotics. This proof of concept trial will help us understand how this treatment works and its acceptability to patients. This study will help us decide whether we should pursue a future formalised randomised controlled trial in many centres throughout the UK and how we should evaluate such a treatment.

  • REC name

    Scotland A: Adults with Incapacity only

  • REC reference

    18/SS/0092

  • Date of REC Opinion

    11 Sep 2018

  • REC opinion

    Further Information Favourable Opinion