Phenotyping bronchiectasis over 2 years including a macrolide trial

• Research type

  Research Study

• Full title

  Phenotyping bronchiectasis based on aetiology, exacerbation characteristics and response to erythromycin.

• IRAS ID

  93212

• Contact name

  Ian Pavord

• Sponsor organisation

  University Hospitals Leicester NHS Trust

• Eudract number

  2012-002792-34

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Phenotyping bronchiectasis based on aetiology and exacerbation characteristics. A 2 year observational randomised, double blind case-controlled study with a period of intervention with erythromycin. Bronchiectasis is a potentially disabling respiratory condition characterised by chronic sputum production and recurrent chest infections. It is usually diagnosed by a CT scan and as CT scans are being performed more frequently we are diagnosing bronchiectasis more often. We would like to invite 58 people who have been diagnosed with bronchiectasis according to their symptoms and a recent CT scan to take part in our two phase study. In the first phase we will perform blood tests, breathing tests, sputum tests and complete quality of life questionnaires as well as taking a history regarding past symptoms and the start of the symptoms. This will enable us to identify any possible cause for the condition and provide us with a baseline upon which to compare future investigations. Our study participants will have the same breathing and sputum tests and questionnaires every 3 months. We will also review any study participant in our clinic with further tests should they have a flare up (exacerbation) of their chest. The second phase involves taking a low dose of a common antibiotic called erythromycin, or a dummy tablet (placebo), once a day for 3 months. The placebo group exists to enable us to evaluate the true effect of the antibiotic. The antibiotic is able to treat infection and reduce airway inflammation and participants will be followed up at 3 monthly intervals to assess any response, particularly the number of exacerbations and the quality of life questionnaire scores.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  12/EM/0370

• Date of REC Opinion

  31 Oct 2012

• REC opinion

  Further Information Favourable Opinion