Healthy volunteers get bronchoscopy to uncover steroid secrets
NCT ID NCT02476825
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how a common asthma inhaler (fluticasone propionate) changes gene activity and cell types in the lungs of 30 healthy adults. Participants will take the inhaler for 4 weeks and have a bronchoscopy (a camera down the airway) to collect samples. The goal is to understand the drug's effects on normal lungs, not to treat any disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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30 people
The number who actually took part.
- Started
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Jan 2016
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University Hospitals of Leicester NHS Trust
Leicester, Leics, LE39QP, United Kingdom
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