Small Particle Steroids in Asthma. V1

• Research type

  Research Study

• Full title

  Small Particle Inhaled Steroids in Refractory Steroid-responsive Asthma

• IRAS ID

  41562

• Contact name

  Tim Harrison

• Sponsor organisation

  University of Nottingham

• Eudract number

  2010-018249-78

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Small Particle Inhaled Steroids in Refractory Asthma (SPIRA): does the addition of an inhaled steroid with extra-fine particle size (ciclesonide) benefit patients already on high dose inhaled steroids? Refractory asthma (asthma which is not controlled with standard inhalers) is a common problem in clinical practice. Current evidence suggests that there is little benefit from increasing the dose of standard inhaled steroids over 1000mcg of beclomethasone or equivalent. However, we commonly see patients on high dose inhaled steroids who respond to oral steroids. One reason for this may be that standard inhaled steroids do not treat distal airway inflammation. We therefore propose a single-centre randomised placebo-controlled clinical trial to determine if the addition of an inhaled steroid with a small particle size (ciclesonide) is of therapeutic benefit in these patients. The trial will be funded by the Nottingham Respiratory Biomedical Research Unit (BRU) based in the Clinical Sciences Building and City Hospital Campus. Patients will be in trial for 14 weeks in total with 40 patients recruited over 21 months.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  10/H0408/19

• Date of REC Opinion

  6 Apr 2010

• REC opinion

  Favourable Opinion