RPL554 in adult patients with mild to moderate chronic asthma

• Research type

  Research Study

• Full title

  A Phase II, randomised, double blind, placebo controlled, seven way crossover study to assess the effect of single doses of RPL554 compared to salbutamol and placebo administered by nebuliser on lung function of patients with chronic asthma

• IRAS ID

  174138

• Contact name

  Johnston Stewart

• Contact email

  adrian.stewart@celerion.com

• Sponsor organisation

  Verona Pharma plc

• Eudract number

  2014-005615-17

• Duration of Study in the UK

  0 years, 6 months, days

• Research summary

  This is a seven way crossover randomised study in patients with mild to moderate chronic asthma.
  All patients will receive seven different treatments and the order of treatment will be random. Neither the patient nor the doctor will know the treatment (a double blind design) the patient is receiving.
  Patients will visit the hospital for seven 1-day treatment visits. There will be a gap of 3 to 14 days between each of the 7 treatment visits.
  The 7 treatments each patient will receive include four different single doses of RPL554 (test drug)(0.4 mg, 1.5 mg, 6 mg and 24 mg), two different doses of standard asthma treatment (2.5 mg and 7.5 mg salbutamol) and a single dose of placebo (an inactive drug).
  For each patient, the length of treatment will be up to 84 days including seven treatment visits with the gap of 3 to 14 days between each visit. The length of the study for each patient will be up to 104 days (including 2 to 10 days screening, up to 84 days treatment and a final visit 2 to 10 days after the last treatment visit).
  All treatments will be inhaled (breathed in) via a nebulizer. A nebulizer is a machine which changes liquid medicine into a fine mist that is easily inhaled.
  This main goal of the study is to assess the effect of the 4 doses of RPL554 (given by nebuliser) on the airways of the lungs when comparing it to placebo and salbutamol and to establish an effective dose of RPL554.

• REC name

  HSC REC B

• REC reference

  15/NI/0040

• Date of REC Opinion

  22 Apr 2015

• REC opinion

  Further Information Favourable Opinion