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Study comparing fluticasone furoate and vilanterol inhalation powder with BREO ELLIPTA in adults with asthma to evaluate their therapeutic equivalence and safety

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on asthma, a breathing condition that causes airways to narrow and swell. The research compares two inhaled medications: a new generic version and the existing brand-name medication called BREO ELLIPTA. Both medications contain the same active substances: fluticasone furoate and vilanterol. These medications are delivered through an inhaler device as a powder that patients breathe in.

The purpose of this study is to show that the new generic medication works as well as the brand-name medication in treating asthma symptoms. The study will also compare both medications to a placebo to prove they are effective. During the study, participants will use their assigned inhaler for 4 weeks. Some participants will receive the new generic medication, some will receive BREO ELLIPTA, and others will receive the placebo.

Throughout the study, doctors will measure how well participants can breathe using a test called FEV1 (the amount of air a person can forcefully exhale in one second). They will check this measurement multiple times, including right after starting treatment and at the end of the 4-week period. The study will also track any side effects that participants may experience during treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial medical evaluation
Your lung function will be tested through spirometry (a breathing test that measures how much and how quickly you can move air out of your lungs).
You must not use your rescue inhaler for at least 6 hours before this test.
A reversibility test will be performed using 360 mcg of albuterol inhaler.
Step 2
Preparation period
You will need to stop your current asthma medications.
You will receive a salbutamol/albuterol inhaler to use only when needed for asthma symptoms.
You will learn how to use the study inhaler device correctly.
Step 3
Treatment period - Day 1
You will be randomly assigned to receive either:
- Fluticasone furoate/vilanterol powder inhaler (100 mcg/25 mcg)
- Breo Ellipta inhaler (100 mcg/25 mcg)
- or a placebo inhaler
Your lung function will be measured multiple times over 24 hours.
Step 4
4-week treatment period
You will use your assigned inhaler daily for 4 weeks.
You can continue using the rescue inhaler (salbutamol/albuterol) when needed for symptoms.
Regular check-ups will monitor your health and any side effects.
Step 5
Final evaluation
On the last day of the 4-week period, your lung function will be measured in the morning before using your inhaler.
A final health assessment will be performed.
The study team will review any side effects or health changes you experienced during the study.

Who can join the trial?

13 criteria

Age between 18 and 75 years old at the time of screening
Must have been diagnosed with asthma at least 12 weeks before screening
Must be a non-smoker for the past year. Former smokers are allowed if they smoked less than the equivalent of 1 pack per day for 10 years
Must be able to use an inhaler device correctly
Must be willing to switch current rescue inhaler to salbutamol/albuterol inhaler and use it only when needed
Must be able to avoid using rescue inhaler for at least 6 hours before lung function tests
Must have stable asthma treatment for at least 4 weeks before screening
Must have lung function (FEV1) between 40% and 85% of predicted normal value before using bronchodilator medication
Must show improvement in lung function of at least 12% and 200 mL after using albuterol inhaler
Must be able to stop current asthma medications during the study period
Must be able to provide informed consent and follow study requirements
For women who can become pregnant: must have negative pregnancy test and use effective birth control during the study
For men with partners who can become pregnant: must use effective birth control and not donate sperm during the study

Who cannot join the trial?

15 criteria

Age below 18 years old or above 65 years old
Pregnant or breastfeeding women
History of severe allergic reactions to fluticasone or vilanterol (the active ingredients in the study medications)
Current smokers or those who quit smoking less than 6 months ago
Severe asthma attacks requiring hospitalization in the past 3 months
Other significant lung diseases besides asthma
Uncontrolled high blood pressure
Serious heart conditions
Active respiratory tract infection
Use of other asthma medications that could interfere with the study
Participation in another clinical trial within the last 30 days
History of drug or alcohol abuse within the past 2 years
Any condition that the study doctor believes would make participation unsafe
Unable to use the inhaler device correctly after training
Known or suspected problems with following study procedures

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Verified sites

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Linden Sp. z o.o. sp.k.
Responsive
Cracow, Poland
Not recruiting
Wojewodzki Szpital Spec im. sw. Rafala w Czerwonej Gorze Swietokrzyskie Centrum Chorob Pluc
Verified
Checiny, Poland

Trial locations

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Investigated drugs

Fluticasone furoate
is an inhaled corticosteroid medication that helps reduce inflammation in the airways. It works by decreasing swelling and irritation in the lungs, making it easier to breathe. This medication is commonly used to control and prevent asthma symptoms.
Vilanterol
is a long-acting beta-agonist (LABA) that helps relax and open the airways in the lungs. It works by relaxing the muscles around the airways, making breathing easier for people with asthma. This medication provides long-lasting relief of asthma symptoms for up to 24 hours.
BREO ELLIPTA
is a combination inhaler containing both fluticasone furoate and vilanterol. This combination medication helps control asthma in two ways: by reducing inflammation in the airways and by keeping the airways open. It is taken once daily to help prevent and control asthma symptoms.

What is already known about the treatment

Fluticasone furoate
An inhaled corticosteroid medication delivered through a dry powder inhaler that helps control and prevent asthma symptoms. This synthetic steroid works by reducing inflammation in the airways of the lungs, making breathing easier for patients with asthma. It belongs to the class of corticosteroid medications and is typically used as a maintenance treatment, requiring regular daily use to achieve optimal therapeutic effects.
Vilanterol
A long-acting beta-2 agonist (LABA) administered via inhalation that works by relaxing and opening the airways in the lungs. When combined with fluticasone furoate in products like Breo Ellipta, it provides both immediate bronchodilation and long-term asthma control. This medication helps improve breathing by keeping the airways open for up to 24 hours, making it suitable for once-daily dosing in asthma management.
Breo Ellipta
A combination inhaler containing both fluticasone furoate and vilanterol, delivered through a specialized dry powder inhaler device. This medication combines the anti-inflammatory effects of a corticosteroid with the bronchodilating properties of a long-acting beta agonist, providing comprehensive asthma control through once-daily administration. The combination has been proven effective in clinical trials for managing persistent asthma symptoms and preventing asthma exacerbations.

Investigated diseases

Asthma - A chronic respiratory condition that affects the airways in the lungs. It causes the air passages to become inflamed and narrow, leading to recurring episodes of breathing difficulties, wheezing, chest tightness, and coughing. The airways become more sensitive to various triggers such as allergens, cold air, exercise, or stress. During an asthma episode, the muscles around the airways tighten, the lining of the airways becomes swollen, and more mucus is produced than usual. These changes make the airways narrower, making it harder to breathe, especially when exhaling.