Bioequivalence of fluticasone propionate and salmeterol xinafoate inhalation powder for asthma in healthy volunteers

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What is this study about?

The study involves two common lung conditions: asthma, in which the airways become narrowed and inflamed causing wheezing and shortness of breath, and chronic obstructive pulmonary disease, a long‑term disease that makes it hard to move air in and out of the lungs. Both conditions are often treated with an inhaler that contains a corticosteroid, a medicine that reduces swelling, and a long‑acting bronchodilator, a medicine that helps keep the airways open. The inhaled medicines being compared are a combination of fluticasone propionate and salmeterol xinafoate delivered as a dry powder, tested against the reference product ADVAIR Diskus.

The purpose of the trial is to determine whether the test inhaler provides the same overall exposure to the medicines in the body as the reference inhaler, a concept known as bioequivalence.

Healthy volunteers will receive a single dose of one inhaler, then after a short break will receive a single dose of the other inhaler. Blood samples will be taken at several time points after each dose to measure how much of the medicines enter the bloodstream, allowing comparison of the two products.

1 initial visit and randomization

you arrive at the clinic after an overnight fast. you will not eat or drink anything except water for at least 10 hours before each dosing day.

baseline measurements such as height, weight, vital signs, and a brief medical questionnaire are recorded.

you are randomly assigned to receive either the test inhaler (fluticasone propionate 250 µg + salmeterol xinafoate 50 µg) first or the reference inhaler (advair diskus 250/50) first.

2 first dose administration

under supervision, you inhale a single dose from the assigned inhaler. each inhalation delivers 250 µg of fluticasone propionate and 50 µg of salmeterol xinafoate.

the inhalation is performed once, using the device as instructed, and no additional doses are taken on that day.

3 blood sampling after first dose

blood samples are collected to measure the amount of medication in your bloodstream.

samples are taken before the dose (time = 0) and then at the following intervals: 3 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour 20 minutes, 1 hour 40 minutes, 2 hours, 2 hours 30 minutes, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 14 hours, 16 hours, 24 hours, and 36 hours after the inhalation.

each sample is taken by a trained staff member while you remain fasted.

4 washout period

after the first dosing period, a washout interval separates the two study periods. during this time you do not use any study medication and you resume normal activities.

5 second dose administration

you return after another overnight fast and undergo the same baseline checks as before.

you inhale a single dose from the inhaler you did not receive in the first period. the dose again contains 250 µg of fluticasone propionate and 50 µg of salmeterol xinafoate.

the inhalation is performed once, exactly as instructed.

6 blood sampling after second dose

the same series of blood samples is collected as after the first dose: before the dose and at 3 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour 20 minutes, 1 hour 40 minutes, 2 hours, 2 hours 30 minutes, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 14 hours, 16 hours, 24 hours, and 36 hours post‑inhalation.

these samples allow comparison of how the two inhalers deliver the medication.

7 final assessment and study completion

after the last blood collection, final safety checks and a brief questionnaire are completed.

you are informed that the study procedures are finished and no further study medication is required.

Who Can Join the Study?

Healthy volunteers of both genders, aged between 18 and 60 years
Body Mass Index (BMI) between 18.5 and less than 30 kg/m² (BMI is a number that relates a person’s weight to their height)
Declared healthy after a review of medical history, physical exam, ECG (a test that records the heart’s electrical activity), pulmonary function test (a breathing test), and laboratory results that are normal or not considered a health problem
Female participants must either be unable to become pregnant or, if they can become pregnant and are sexually active, must use an effective method of birth control starting 14 days before the first dose and continue throughout the study
Must be a non‑smoker (does not currently smoke cigarettes or use other tobacco products)
Must be able to understand the study, follow the procedures, and sign the informed consent form
Must be able to use the inhaler device correctly as instructed by the study staff

Who Cannot Join the Study?

Allergy to the study drug or any of its ingredients (including lactose, which can contain milk protein) or to similar medicines such as drugs that act like adrenaline (sympathomimetic) or any inhaled or systemic corticosteroids.
Inability to avoid drinking alcohol for the entire study period.
Test results showing infection with hepatitis B, hepatitis C, or HIV.
Positive drug test in saliva before each dose.
Positive breath alcohol test before each dose.
Use of “soft” drugs (e.g., marijuana) within 3 months before screening, or use of hard drugs such as crack, cocaine, or heroin within 1 year before screening.
Taking any medicines that change how the liver processes drugs (enzyme inducers or inhibitors) within 1 month before the study dose.
History of stomach ulcer, ongoing gastrointestinal problems (e.g., chronic diarrhea, irritable bowel syndrome) or any significant liver (hepatic), kidney (renal), or other condition that could affect drug absorption or elimination.
Use of oral or injected steroids in the past 4 weeks.
Eye disorders, especially glaucoma, or a family history of glaucoma.
Use of prescription medication within 14 days before the first dose, or over‑the‑counter products, vitamins, or herbal supplements within 7 days before the first dose, except for topical products that are not absorbed systemically (birth‑control pills are allowed).
Serious illness or surgery within 4 weeks before dosing.
Receiving a flu vaccine or any other vaccination within 7 days before a dose.
Known food allergy, intolerance, or special diet that could make participation unsafe.
Having a long‑acting injection or implant of any drug (except hormonal contraceptives) within 3 months before the dose.
Donating 500 ml of plasma within 7 days before the dose.
Donating whole blood or losing 500 ml or more of blood within 30 days before the dose.
Participating in another clinical trial at the same time.
Being on a special diet, being intolerant of the study meals, or refusing to eat the study meals.
Getting a new tattoo or body piercing within 30 days before the dose.
Inability to tolerate blood draws (venipuncture).
Currently breastfeeding.
Significant abnormalities on a heart‑electrocardiogram (ECG) or blood pressure or heart rate outside normal ranges (systolic 140 mmHg, diastolic 90 mmHg, heart rate 100 bpm) at screening.
Positive pregnancy test at screening.
History or current chronic bronchitis, emphysema, asthma, or any other lung disease.
History or current pulmonary (lung) tuberculosis.
Viral or bacterial infection of the upper or lower respiratory tract, sinus, or middle ear within 4 weeks before screening.
History or presence of serious heart, hormonal, nervous system, immune, psychiatric, or metabolic disease.
History of significant alcohol or drug abuse within the past year.
Regular heavy drinking (more than 14 alcohol units per week) in the past 6 months.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
BECRO Ltd Clinical Facility General clinic ‘Eftychios Patsidis’	Larissa	Greece

Trial status

Country	Status	Recruitment Start
Greece	Not recruiting	17.07.2023

Trial locations

Investigated Drugs:

Fluticasone propionate and salmeterol inhalation powder (Respirent Pharmaceuticals) is a pre‑filled inhaler that delivers a combination of two medicines to the lungs. Fluticasone propionate is a steroid that reduces inflammation in the airways, helping to keep them open. Salmeterol is a long‑acting bronchodilator that relaxes the muscles around the airways, making breathing easier. In this study the inhaler is used as the test product to see how its absorption and overall effect compare with the same medicines delivered by another inhaler.

ADVAIR Diskus is a well‑known inhaler that also provides a fixed‑dose combination of fluticasone propionate and salmeterol. Like the test inhaler, it contains a steroid to lower airway inflammation and a long‑acting bronchodilator to keep the airways relaxed. In the trial it serves as the reference product, allowing researchers to determine whether the test inhaler works in the same way as this established medication.

Investigated Diseases:

Asthma – Asthma is a long‑term condition that makes the airways in the lungs easily swell and tighten. This causes episodes of wheezing, shortness of breath, chest tightness, and coughing. Triggers such as allergens, cold air, or exercise can start an episode. Over time, the airways may become more sensitive, leading to more frequent symptoms. The disease often starts in childhood but can continue into adulthood.

Chronic obstructive pulmonary disease – Chronic obstructive pulmonary disease (COPD) is a progressive lung disorder that limits the flow of air in and out of the lungs. It includes chronic bronchitis, where the airways produce excess mucus, and emphysema, where the air‑sac walls break down. Symptoms such as a persistent cough, mucus production, and breathlessness usually worsen slowly over many years. The condition is most common in people who have smoked or been exposed to lung irritants. As the disease advances, everyday activities can become increasingly difficult because of reduced breathing capacity.

Trial ID:

2023-505198-34-00

Protocol code:

BECRO/RESP/AEROPK250

Trial Phase:

Human Pharmacology (Phase I) – Bioequivalence Study

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Bioequivalence of fluticasone propionate and salmeterol xinafoate inhalation powder for asthma in healthy volunteers

What is this study about?

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