NCT02883530

Refractory Asthma Stratification Programme (RASP) Bronchoscopy Study

Status unknown Last updated 5 January 2024

What this trial tests

trial testing Bronchoscopy in Persistent Asthma in 160 participants. Status unknown.

Timeline

26 September 2016

Primary endpoint
31 October 2024

31 October 2024

Quick facts

Lead sponsor	University of Leicester
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	160
Start date	26 September 2016
Primary completion	31 October 2024
Estimated completion	31 October 2024
Sites	8 locations across United Kingdom

Drugs / interventions tested

• Bronchoscopy

Conditions studied

• Persistent Asthma — all drugs for Persistent Asthma →

Sponsor

University of Leicester

Who can join

Adults 18 to 65, any sex, with Persistent Asthma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The Investigators hypothesise that asthma is not a single disease, but a syndrome resulting from several distinct underlying disease processes known as endotypes. There are approximately 30,000 genes in humans, and each gene is responsible for the production of a particular protein. Using a technique called "whole genome expression profiling" The Investigators have undertaken a small study looking at the activity of all 30,000 genes in the airway tissue of people with asthma. This work has identified 3 mutually exclusive distinct molecular patterns (endotypes) of severe asthma and has identified other potentially important molecular targets (manuscripts in preparation). In particular,the Investigators have found that 25-50% of patients have asthma associated with the activity of proteins called Th2 cytokines (Th2-high asthma). New treatments are in development that target this pathway. However, the Investigators do not know what is driving severe asthma in patients who do not express these Th2 cytokines. The aim of this study is to investigate in more detail the molecular mechanisms driving severe asthma in patients who do not express Th2 cytokines (Th2-low asthma), so that the Investigators can identify new targets for treatment in this group. To do this the Investigators will collect airway tissue via a telescope (bronchoscope), and analyse gene and protein expression in the tissue. The Investigators will then compare the molecular activity between patients with Th2-high and Th2-low asthma, and healthy control subjects (data obtained from a parallel study).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Fractional Exhaled Nitric Oxide Nonsuppression Identifies Corticosteroid-Resistant Type 2 Signaling in Severe Asthma.
   Couillard S, Shrimanker R, Chaudhuri R, Mansur AH, et al · · 2021 · cited 60× · PMID 34129808 · DOI 10.1164/rccm.202104-1040le
2. Airway remodelling rather than cellular infiltration characterizes both type2 cytokine biomarker-high and -low severe asthma.
   Khalfaoui L, Symon FA, Couillard S, Hargadon B, et al · · 2022 · cited 29× · PMID 35579040 · DOI 10.1111/all.15376