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HealthyPhase 4NCT02476825

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

A Phase 4 study testing Fluticasone propionate and Accuhaler in people with Healthy, run by University Hospitals, Leicester at 1 site in United Kingdom.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Fluticasone propionate and Accuhaler
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited Kingdom
Study dates
20 Jan 2016to 31 Oct 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • Failure to meet the inclusion criteria
  • 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
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  • 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
  • Presence of clinically significant abnormality on Screening Coagulation Panel
  • Presence of clinically significant medical comorbidities that, in the opinion of the investigator, may make the patient unsuitable for elective bronchoscopy or would impact on study efficacy assessments
  • A history of atopic disease (allergic rhinitis [perennial or seasonal], atopic dermatitis, food allergy)
  • History of alcohol or drug abuse that would impair or risk the patient's full participation in the study, in the opinion of the investigator
  • Current smoker, former smoker with smoking history of >10 pack-years.
  • Treatment with anticoagulant medications including but not limited to aspirin,warfarin or antiplatelet medication
  • Use of a licensed or investigational monoclonal antibody within 6 months or 5 drug half-lives prior to Visit 1 (whichever is longer)
  • Use of a systemic immunomodulatory or immunosuppressive therapy within 6 months or 5 drug half-lives prior to Visit 1 (whichever is longer).
  • Use of other investigational therapy not described above within 6 months or 5 drug half-lives prior to Visit 1 (whichever is longer)
  • Receipt of a live attenuated vaccine within 4 weeks prior to Visit 1
  • Use of complementary, alternative, or homeopathic medicines including, but not limited to traditional or non-traditional herbal medications within 3 months
  • Scheduled elective surgery or other procedures requiring general anaesthesia during the study
  • Donation of blood during the study or within the past 12 weeks
  • BMI >38 kg/m2
  • Body weight <40 kg

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • University Hospitals of Leicester NHS Trust

    Leicester, Leics, LE39QP

Other trials in United Kingdom

About this study

Official title: A Randomized, Open-labelled Bronchoscopy Study to Assess the Effects of Inhaled Corticosteroids (ICS) on Adult Healthy Volunteers

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.

Read the detailed description

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. This study will allow a more accurate assessment of the changes in gene/protein expression and cellularity that drive severe treatment-resistant asthma by allowing for the effects that are due to corticosteroids rather than the disease to be considered. This improved mechanistic understanding is important to identify novel therapeutic targets in severe asthma, and to support the development of novel therapeutics. The primary endpoint is the corticosteroid-inducible gene expression pattern in healthy airways.

Approximately 30 healthy adult subjects (age 18-65) will be randomised in a 2:1 ratio to one of two study groups: i) patients will receive fluticasone propionate 500 mcg b.i.d. via Accuhaler for 4 weeks (n=20), or ii) patients will receive no treatment for 4 weeks (n=10). Bronchoscopy will be performed in all patients at baseline, prior to the start of the treatment period and at the end of week 4. The PI, Genentech and Leicester laboratory support staff will be blinded to treatment allocation. A control arm is included to assess the repeatability of the planned analyses, the stability of the gene expression profiles measured during this study period, and to provide a comparator to the treatment group.

Written informed consent for participation in the study must be obtained before performing any study-specific tests or evaluations. Consent will be obtained at the screening visit. At screening, important co-morbidities will excluded . Patients will also be randomised at this screening visit.

To ensure there are sufficient data for analysis, if a subject withdraws before completion of the study, they will be replaced with another subject.

Conditions
Healthy
Being tested
Fluticasone propionate, Accuhaler
Keywords
volunteers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluticasone propionateDrug

    Also called Flixotide

    Flixotide Accuhaler 500 micrograms b.i.d.

  • AccuhalerDevice

    Flixotide Accuhaler 500 micrograms b.i.d.

Study groups in NCT02476825
Study groupRoleWhat they receive
Inhaled fluticasoneActive comparatorInhaled fluticasone propionate (via dry powder inhaler [Accuhaler]), 500 micrograms b.i.d. for 4 weeks
Receives: Drug: Fluticasone propionate; Device: Accuhaler
ObservationalNo interventionObservation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 months after last patient visit

Secondary outcomes (4)

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

    Measured: 18 months after last patient visit

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

    Measured: 18 months after last patient visit

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

    Measured: 18 months after last patient visit

  4. 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

    Measured: 18 months after last patient visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2015 (estimated)
  2. Study start20 Jan 2016
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion31 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02476825
Sponsor's protocol ID
168769
Status last verified
Mar 2025
First submitted
17 Jun 2015
Last updated
2 Mar 2026
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 38686450

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fluticasone propionate and Accuhaler in people with Healthy, run by University Hospitals, Leicester at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relative change from baseline in airway tissue gene expression following 4-weeks of inhaled fluticasone propionate treatment (time frame: 6 months after last patient visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02476825, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.

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