A Phase 1b three-way crossover study of PUR1800 in patients with COPD.

• Research type

  Research Study

• Full title

  A Phase 1b randomized, double-blind, placebo-controlled, 3-way crossover study to assess the safety, tolerability and pharmacokinetics of repeated once daily doses of PUR1800, a narrow spectrum kinase inhibitor (NSKI) administered as a dry powder for inhalation in adult patients with stable chronic obstructive pulmonary disease.

• IRAS ID

  277206

• Contact name

  Audrey Rossow

• Contact email

  arossow@pulmatrix.com

• Sponsor organisation

  Pulmatrix Inc

• Eudract number

  2019-004810-33

• Clinicaltrials.gov Identifier

  NCT04759807

• Duration of Study in the UK

  0 years, 8 months, 6 days

• Research summary

  Research Summary

  This study is being conducted for research purposes. The study drug, “PUR1800” is being investigated as a potential treatment for chronic obstructive pulmonary disease (COPD); especially for treating flareups of COPD known as COPD exacerbation.

  PUR1800 belongs to a class of drugs called “anti-inflammatories” which reduce inflammation and could lessen symptoms such as cough, wheeze and shortness of breath during a COPD exacerbation.

  The purpose of this study is to look at the potential side effects of different doses of PUR1800 and how the body absorbs and breaks down PUR1800, known as pharmacokinetic (PK) analysis. PK analysis will be performed on sputum (phlegm) and blood samples. In addition, biomarker testing will be performed, which looks at certain biological features of the samples to measure the presence or progress of disease or the effects of a treatment.

  In this study, the study drug PUR1800 will be given once a day for 14 days and then again after a washout period. This study also involves taking placebo (a dummy drug product that doesn’t contain any active ingredients) once a day for 14 days.

  The study drug will be given in the form of a capsule which is placed inside an inhaler to inhale.The study drug will be given at two different dose levels as well as a placebo, as shown below:
  - Treatment -Placebo capsule, Once every day for 14 days
  - Treatment 250 microgram capsule, Once every day for 14 days
  - Treatment 500 microgram capsule, Once every day for 14 days

  Summary of Results

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  20/NW/0117

• Date of REC Opinion

  30 Mar 2020

• REC opinion

  Further Information Favourable Opinion