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Healthy volunteers get bronchoscopy to uncover steroid secrets

NCT ID NCT02476825

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

30 people

The number who actually took part.

Started

Jan 2016

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University Hospitals of Leicester NHS Trust

    Leicester, Leics, LE39QP, United Kingdom

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