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

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What is this study about?

The study involves healthy volunteers and looks at medicines used for bronchial asthma and chronic obstructive pulmonary disease. Both conditions affect the airways and can cause coughing, wheezing, and shortness of breath. The medicines being compared contain a steroid called fluticasone propionate that reduces inflammation, and a long‑acting bronchodilator called salmeterol xinafoate that helps keep the airways open. One inhaler is the brand name ADVAIR Diskus, and the other is a test inhaler made by Respirent.

The purpose of the study is to determine the bioequivalence of the two inhalers, meaning they deliver the same amount of medicine to the body. Participants will receive a single dose of each inhaler on separate visits while fasting, with a washout period between doses. Blood samples will be taken after each dose to see how much of the medicine reaches the bloodstream, and the study will compare the results to see if the test inhaler works the same as the brand inhaler.

1 initial visit and consent

you arrive at the study site after agreeing to take part. the study staff explains what will happen and asks you to sign a consent form. basic health checks are done to confirm you are a healthy volunteer.

2 fasting before each dose

before any inhaled medication is given you must not eat or drink anything except water for at least 10 hours. this ensures the drug is absorbed in a consistent way.

3 first inhaled dose

you use a inhaler that contains fluticasone propionate 500 µg and salmeterol xinafoate 50 µg (total 1000 µg) in powder form. the dose is taken once, as a single inhalation, under the supervision of study staff.

4 observation and blood sampling after first dose

after the inhalation you remain at the clinic for several hours. small blood samples are taken at predefined times to measure how the drug is absorbed and cleared from your body.

5 washout period

there is a break of several days (the exact length is decided by the study protocol) before the next dose. this allows the first medication to leave your system completely.

6 second inhaled dose

after another fasting period you receive the other inhaled product. it also contains fluticasone propionate 500 µg and salmeterol xinafoate 50 µg in powder form, taken once as a single inhalation.

7 observation and blood sampling after second dose

you stay in the clinic again while additional blood samples are collected at the same time points as after the first dose. this provides comparable data for the two products.

8 final visit and study completion

once all samples are taken, you attend a final visit where the study staff reviews any remaining questions and thanks you for your participation. no further medication is required.

Who Can Join the Study?

Healthy volunteers of both genders, aged 18 to 60 years, with no significant medical problems.
Body Mass Index (BMI) between 18.5 and less than 30 kg/m² (a measure of weight compared to height).
Considered healthy after a medical history, physical exam, ECG (a test that records the heart’s electrical activity), a lung test called a pulmonary function test showing forced expiratory volume in 1 second (FEV1) at least 80 % of the normal predicted value, and laboratory tests that are within normal limits.
Women must either be unable to become pregnant (for example, post‑menopausal, have had a hysterectomy, removal of both ovaries, or tubal ligation at least 6 months earlier) or, if they can become pregnant, must use an effective method of birth control from 14 days before the first dose and throughout the study. Effective methods include combined hormonal pills, patches or rings; progestogen‑only pills, implants or injections; intrauterine devices (IUD or IUS); permanent tubal blockage; a partner who has had a vasectomy; or abstinence.
Must be a non‑smoker (does not 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 after instruction.

Who Cannot Join the Study?

Allergy (hypersensitivity) to the study drug or its ingredients, including lactose (a milk‑derived sugar that can cause allergic reactions), or to similar medicines such as any drug that mimics the nervous system (sympathomimetic) or any inhaled, nasal, or oral corticosteroid.
Inability to avoid drinking alcohol for the entire study period.
Positive test for Hepatitis B, Hepatitis C, or HIV (blood‑borne viruses) at screening.
Positive test for illegal drugs (barbiturates, marijuana, opioids, benzodiazepines, methadone) in saliva before each dose.
Positive breath test for alcohol before each dose.
Use of marijuana within the last 3 months, or use of hard drugs such as crack, cocaine, or heroin within the last 1 year.
Use of any medication that changes how the liver processes drugs (hepatic drug metabolism) – examples include barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin, erythromycin, ketoconazole, indinavir, or cobicistat – within the past 1 month.
History of stomach ulcer, chronic diarrhea, irritable bowel syndrome, ongoing gastrointestinal problems, or serious liver, kidney, or other conditions that could affect how the drug is absorbed, distributed, metabolized, or eliminated.
Use of oral or injected corticosteroids in the previous 4 weeks.
Eye disorders, especially glaucoma, or a family history of glaucoma.
Use of prescription medicines within 14 days before the first dose, or over‑the‑counter products, vitamins, or herbal supplements within 7 days, except for skin‑only products; birth‑control pills are allowed.
Vaccination for flu or any other vaccine within 7 days before a dose.
Food allergy, intolerance, or special diet that the investigators consider could make participation unsafe.
Receiving a long‑acting injection or implant of any drug (except hormonal contraceptives) within the past 3 months.
Donation of 500 ml of plasma within 7 days before a dose.
Donation of whole blood or loss of ≥ 500 ml of blood within 30 days before a dose.
Participation in another clinical trial at the same time.
Being on a special diet, unable to tolerate the study meals, or refusing to eat the study meals.
Getting a new tattoo or body piercing within 30 days before a dose.
Inability to tolerate blood draws (venipuncture).
Being a breastfeeding woman.
Significant abnormal heart test (ECG) or abnormal vital signs at screening (blood pressure too low 140 mmHg, diastolic 90 mmHg, or heart rate 100 beats per minute).
Positive pregnancy test at screening.
History or current presence of serious lung disease such as chronic bronchitis, emphysema, asthma, or any other lung condition.
History or current pulmonary tuberculosis.
Viral or bacterial infection of the upper or lower respiratory tract, sinuses, or middle ear within 4 weeks before screening.
Significant history of heart disease, hormonal (endocrine) disorders, nerve (neurologic) disease, immune (immunological) disease, psychiatric illness, or metabolic disease.
History of significant alcohol or drug abuse within the past 1 year.
Regular consumption of more than 14 alcohol units per week (about 1.5 L of wine, 3.6 L of beer, or 45 ml of 40 % spirit) within the past 6 months.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
BECRO Clinical Facility General Clinic “Eftychios Patsidis”	Larissa	Greece

Trial status

Country	Status	Recruitment Start
Greece	Not recruiting	03.07.2023

Trial locations

Investigated Drugs:

ADVAIR Diskus inhalation powder is a pre‑filled inhaler that delivers a combination of two medicines, fluticasone and salmeterol, directly to the lungs. Fluticasone helps reduce inflammation in the airways, while salmeterol works as a long‑acting bronchodilator to keep the airways open. In this trial, ADVAIR Diskus is used as the reference product to compare how the test inhaler performs in delivering the same medicines to healthy volunteers.

Fluticasone propionate and salmeterol inhalation powder (Respirent Pharmaceuticals) is an inhaled powder that also contains the same two medicines—fluticasone to lower airway inflammation and salmeterol to relax the airway muscles. This product is the test formulation being evaluated. The study measures whether this inhaler delivers the medicines to the body in a way that is equivalent to the reference ADVAIR Diskus inhaler.

Investigated Diseases:

Asthma – Asthma is a chronic inflammatory disease of the airways that causes episodes of wheezing, shortness of breath, chest tightness, and cough. The airways become more sensitive and narrow during episodes, leading to difficulty breathing. Over time, repeated inflammation can cause airway remodeling, making symptoms more persistent. Triggers such as allergens, cold air, or exercise can provoke episodes. The condition often begins in childhood but can appear at any age. Symptoms can vary in frequency and severity.
Chronic obstructive pulmonary disease (COPD) – COPD is a progressive lung disease characterized by airflow limitation that is not fully reversible. It includes chronic bronchitis and emphysema, leading to persistent cough, mucus production, and shortness of breath. The disease usually develops slowly over years, often due to long‑term exposure to irritants such as cigarette smoke. Lung tissue damage and airway narrowing worsen over time, reducing the ability to breathe normally. Acute worsening episodes can occur, adding to the overall burden. It mainly affects middle‑aged and older adults.

Trial ID:

2023-504789-48-00

Protocol code:

BECRO/RESP/AEROPK500

Trial Phase:

Human Pharmacology (Phase I) – Bioequivalence Study

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

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