Respiratory

DIBS - Closedown/Analysis

A pragmatic, multicentre, placebo-controlled, 3-arm, double-blinded, randomised controlled trial, incorporating an internal pilot, to determine the role of bronchodilators in preventing exacerbations of bronchiectasis

• Study stage: Closedown/Analysis
• Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust
• Funder: NIHR HTA
• Therapeutic area: Respiratory
• Type of study: CTIMP

Aim: To compare the effects of inhaled dual bronchodilators either as a stand-alone therapy (LABA/LAMA) or in combination with ICS (ICS/LABA/LAMA; triple therapy) therapy to placebo on the number of protocol defined bronchiectasis exacerbations (per participant)

Primary outcome

Number of protocol defined bronchiectasis exacerbations requiring treatment with antibiotics during 12 month treatment period as measured using participant reports/ participant completed weekly exacerbation diary.

• Population: Adult
• Phase: III
• Design: RCT and Health Economic
• Setting: Secondary care
• Planned Sample Size: 600

E-CLAD - Recruiting

Extracorporeal Photophoresis in the treatment of Chronic Lung Allograft Dysfunction: a randomised controlled trial (E-CLAD UK).

• Study stage: Recruiting
• Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust
• Funder: NIHR EME
• Therapeutic area: Cardiovascular
• Type of study: CTIMP

Aim: To determine if extracorporeal photopheresis (ECP) therapy plus standard of care (SOC) is more effective at improving or stabilising lung function in lung transplant recipients with chronic lung allograft dysfunction (CLAD) compared to SOC alone.

Primary outcome:  Composite responder outcome of lung function stabilisation derived from change in Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC) at 12 and 24 weeks

• Clinical Phase: II
• Population: Adults
• Design: RCT
• Setting: Secondary Care
• Planned Sample Size: 90