MEDI3506 in COPD and Chronic Bronchitis

• Research type

  Research Study

• Full title

  A Phase II, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety and Tolerability of MEDI3506 in Participants with Moderate to Severe Chronic Obstructive Pulmonary Disease and Chronic Bronchitis

• IRAS ID

  1003379

• Contact name

  Dinesh Saralaya

• Contact email

  dinesh.saralaya@bthft.nhs.uk

• Eudract number

  2020-000571-20

• Clinicaltrials.gov Identifier

  NCT04631016

• Research summary

  Research Summary

  This is a clinical trial to assess the efficacy (whether it works) and safety of an
  investigational drug called MEDI3506 for the treatment of COPD with chronic
  bronchitis. Despite current standard therapy for COPD some patients continue to
  experience significant ongoing symptoms and/or exacerbations requiring treatment with
  steroids and/or antibiotics.
  Patients in this study will be aged 40-75 years of age, have confirmed diagnoses of
  COPD and chronic bronchitis, have experienced, at least, one exacerbation of COPD in
  the last year and receive current standard therapy for COPD. Eligible patients will be
  randomly assigned to receive either MEDI3506 or placebo (which looks like MEDI3506
  but contains no medication) in addition to their current standard therapy for COPD.
  Neither patients nor the study staff assessing them will know whether they have received
  MEDI3506 or placebo. The study lasts for up to 41 weeks across three stages: screening,
  treatment and follow up, with a total of 14 visits. It will be conducted both in the UK and
  other countries. During the study patients will undergo various procedures including,
  lung function testing, heart scan, CT scan, cough monitoring; and taking blood, urine,
  nasal and sputum (phlegm) samples. Patients will also complete various questionnaires
  about their symptoms and medication usage

  Summary of Results

  Available at https://www.trialsummaries.com/Study/StudyDetails?id=11567&tenant=MT_MED_9011

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  20/SC/0303

• Date of REC Opinion

  9 Oct 2020

• REC opinion

  Further Information Favourable Opinion