A Bronchoscopy Study to Assess the Effects of Inhaled Corticosteroids on Adult Healthy Volunteers

NCT02476825 | Active Not Recruiting Phase 4

• 1 other identifier: 168769
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, single-blind, controlled, single centre bronchoscopy study designed to assess the effects of fluticasone propionate on airway gene expression and cellularity in healthy adult controls without asthma.

Conditions

Healthy

Keywords

volunteers

Outcome Measures

Primary Outcomes (1)

• Relative change from baseline in airway tissue gene expression following 4-weeks of inhaled fluticasone propionate treatment

  6 months after last patient visit

Secondary Outcomes (4)

• Relative change from baseline in airway cellularity following 4-weeks of inhaled fluticasone propionate treatment

  18 months after last patient visit

• Relative change from baseline in airway protein expression following 4-weeks of inhaled fluticasone propionate treatment

  18 months after last patient visit

• Relative change from baseline in peripheral blood gene expression following 4-weeks of inhaled fluticasone propionate treatment

  18 months after last patient visit

• Differentiate pathways, biomarkers, and heterogeneity between gene expression and pathophysiology in severe asthmatics on ICS +/- lebrikizumab (separate Genentech-sponsored study known as CLAVIER) and healthy volunteers on ICS

  18 months after last patient visit

Study Arms (2)

Inhaled fluticasone

ACTIVE COMPARATOR

Inhaled fluticasone propionate (via dry powder inhaler \[Accuhaler\]), 500 micrograms b.i.d. for 4 weeks

Drug: Fluticasone propionate; Device: Accuhaler

Observational

NO INTERVENTION

Observation

Interventions

Fluticasone propionate DRUG

Flixotide Accuhaler 500 micrograms b.i.d.

Also known as: Flixotide

Inhaled fluticasone

Accuhaler DEVICE

Flixotide Accuhaler 500 micrograms b.i.d.

Inhaled fluticasone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant willing and able to give informed consent
• Male or Female, aged 18-65 years at Visit 1
• Forced expiratory volume at one second (FEV1) \>80% predicted
• FEV1/forced vital capacity (FVC) ratio ≥70%
• Non-smoker for \>1 year with \<10 py smoking history
• Female participants of child bearing potential must ensure use of effective contraception during the study
• Participants has clinically acceptable laboratory and ECG at screening
• A chest x-ray confirming the absence of significant lung disease
• A negative result to skin prick testing with common aeroallergens, or, if a skin prick test to a common aeroallergen is positive, a negative response to challenge with methacholine (defined as a provocative concentration causing a 20% fall in FEV1 \[PC20 methacholine\] \>16 mg/ml)
• Able (in the Investigators opinion) and willing to comply with all study requirements

You may not qualify if:

• Female participants who are pregnant, lactating or planning pregnancy during the course of the study
• History of a severe allergic reaction or anaphylaxis to corticosteroids
• Systemic treatment with corticosteroids within last 6 months
• Any infection that resulted in hospital admission for ≥ 24 hours within 4 weeks prior to Visit 1 or during screening
• Any infection that required treatment with IV or intramuscular (IM) antibiotics within 4 weeks prior to Visit 1 or during screening
• Any active infection that required treatment with oral antibiotics within 2 weeks prior to Visit 1 or during screening
• Upper or lower respiratory tract infection within 4 weeks prior to Visit 1 or during screening
• Active tuberculosis requiring treatment within 12 months prior to Visit 1
• Known immunodeficiency including but not limited to HIV infection
• Evidence of acute or chronic hepatitis or known liver cirrhosis
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin elevation ≥2.0 × the upper limit of normal (ULN) during screening
• Clinically significant abnormality on screening ECG or laboratory tests (haematology, serum chemistry, and urinalysis) that, in the opinion of the investigator, may pose an additional risk in administering study drug to the patient or performing bronchoscopy
• Known current malignancy or current evaluation for a potential malignancy
• Unable to safely undergo elective flexible fiberoptic bronchoscopy because of any one of the following:
• History of allergic reaction to local anesthetics to be used during the bronchoscopy

Sponsors & Collaborators

• University Hospitals, Leicester: lead
• Genentech, Inc.: collaborator

Study Sites (1)

University Hospitals of Leicester NHS Trust

Leicester, Leics, LE39QP, United Kingdom

Location

Related Publications (1)

• Marchi E, Hinks TSC, Richardson M, Khalfaoui L, Symon FA, Rajasekar P, Clifford R, Hargadon B, Austin CD, MacIsaac JL, Kobor MS, Siddiqui S, Mar JS, Arron JR, Choy DF, Bradding P. The effects of inhaled corticosteroids on healthy airways. Allergy. 2024 Jul;79(7):1831-1843. doi: 10.1111/all.16146. Epub 2024 Apr 30.

  PMID: 38686450 DERIVED

MeSH Terms

Interventions

Fluticasone

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Peter Bradding, DM

  University of Leicester/University Hospitals of Leicester NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2015
• First Posted: June 19, 2015
• Study Start: January 20, 2016
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: March 2, 2026

Record last verified: 2025-03

Locations

GB (1)