Study on the Effectiveness and Safety of Fluticasone Propionate and Salbutamol Sulfate for Asthma in Patients Aged 12 and Older

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What is this study about?

This clinical trial is focused on studying the effectiveness and safety of a combination treatment for asthma, a condition that affects the airways in the lungs, making it difficult to breathe. The study will involve a combination of two medications: fluticasone propionate and salbutamol sulfate. Fluticasone propionate is a type of medication known as a corticosteroid, which helps reduce inflammation in the airways. Salbutamol sulfate, also known as albuterol, is a bronchodilator that helps open up the airways to make breathing easier. The combination treatment is delivered through a special inhaler called a multidose dry powder inhaler. The study will also compare this combination treatment to the individual use of fluticasone propionate, salbutamol sulfate, and a placebo.

The purpose of the study is to evaluate how well the combination treatment works in improving lung function and controlling asthma symptoms in participants aged 12 years and older. Participants will be randomly assigned to receive either the combination treatment, one of the individual medications, or a placebo. The study will last for four weeks, during which participants will use the inhaler as directed and attend regular check-ups to monitor their progress. The study aims to see if the combination treatment can provide better control of asthma symptoms compared to the individual medications or placebo.

Throughout the study, participants will be monitored for any changes in their asthma symptoms and overall health. The study will also track any side effects that may occur. By the end of the study, researchers hope to gather valuable information on the effectiveness and safety of the combination treatment for managing asthma. This information could help improve treatment options for people living with asthma in the future.

1 beginning of the trial

Upon joining the trial, you will be assigned to one of the treatment groups. This assignment is random, meaning it is like flipping a coin to decide which group you will be in. You will not know which treatment you are receiving, and neither will the study team. This is called a double-blind study.

2 medication administration

You will receive an inhaler that contains either a combination of fluticasone propionate and salbutamol sulfate, fluticasone propionate alone, salbutamol sulfate alone, or a placebo. A placebo looks like the real medication but does not contain any active ingredients.

The medication is administered through inhalation. You will be instructed on how to use the inhaler properly. It is important to follow these instructions carefully to ensure the medication is effective.

3 medication schedule

You will use the inhaler as directed by the study team. The frequency and dosage will be explained to you, and it is important to adhere to this schedule throughout the trial period, which lasts for 4 weeks.

4 monitoring and assessments

Throughout the trial, your lung function will be monitored. This involves measuring how much air you can exhale in one second, known as FEV1. These measurements help assess how well the medication is working.

You will also complete questionnaires about your asthma symptoms and how they affect your daily life. This information is important for understanding the impact of the treatment.

5 follow-up visits

You will have scheduled visits to the study center during the trial. These visits are necessary for the study team to check your health, collect data, and ensure the trial is proceeding safely.

If you experience any side effects or have concerns during the trial, it is important to report these to the study team immediately.

6 end of the trial

At the end of the 4-week period, you will have a final visit to the study center. Your health will be assessed, and you will return any unused medication.

The study team will discuss the next steps with you, including any follow-up care or additional information about the trial results.

Who Can Join the Study?

The participant must be able to give signed informed consent if they are 18 years or older. If the participant is between 12 to 17 years old, they must provide assent (agreement) and a parent or legal representative must give written consent.
The participant must be a male or female aged 12 years or older.
The participant must have been diagnosed with asthma for at least 6 months, following specific medical guidelines.
The participant must have a lung function test result called FEV1 (a measure of how much air you can forcefully exhale in one second) between 50% to 85% of the predicted normal value for adults, and between 50% to 90% for those aged 12 to 17 years.
The participant must be able to perform a breathing test called spirometry correctly during the screening visit.
The participant must show a response to a bronchodilator test, which means their FEV1 should increase by at least 15% after using a medication called albuterol. For those 18 years and older, the FEV1 should also increase by at least 200 mL.
The participant must demonstrate the correct use of a training inhaler after receiving training.
The participant must be able to perform PEF (Peak Expiratory Flow) measurements using a handheld device, as judged by the investigator.
The participant must currently use a medication called a beta-agonist (like albuterol) as a rescue medication, with or without other asthma controller medications. If they are on a stable asthma controller medication, it should not have changed in dose or frequency for 30 days before the first visit. They should be able to stop these medications for a short period as required by the study.
If the participant is female, they must not be pregnant, breastfeeding, or trying to become pregnant for at least 30 days before the screening visit and throughout the study. If they can have children, they must have a negative pregnancy test and agree to use a highly effective birth control method.
The participant must be willing and able to follow the study rules, stay at the study center for the required time, and return for follow-up visits and procedures.

Who Cannot Join the Study?

Patients with a history of severe allergic reactions to any of the ingredients in the study medication cannot participate. An allergic reaction is when your body reacts badly to something, like a rash or trouble breathing.
Patients who have had a lung infection in the past month are not eligible. A lung infection can cause symptoms like coughing, fever, and difficulty breathing.
Patients who are currently using other medications that might interfere with the study drug cannot join. This means if you are taking certain other medicines, you might not be able to participate.
Patients with a history of heart disease are excluded. Heart disease affects how well your heart works.
Patients who have been diagnosed with cancer in the past five years cannot take part. Cancer is a disease where cells in the body grow uncontrollably.
Patients who are pregnant or breastfeeding are not allowed to participate. This is to ensure the safety of both the mother and the baby.
Patients who have participated in another clinical trial in the last 30 days are not eligible. This is to make sure the results of this study are not affected by other studies.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
Alergo Med Osrodek Badan Klinicznych Sp. z o.o.	Tarnow	Poland
Hornmed s.r.o	Brno	Czechia
Multiprofile Hospital For Active Treatment Hadji Dimitar OOD	Sliven	Bulgaria
Lungenpraxis Witten	Witten	Germany
Research Center for Medical Studies (RCMS)	Berlin	Germany

Other Sites

Site Name	City	Country
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov	Sofia	Bulgaria
Santa Sp. z o.o.	Lodz	Poland
Univerzitna Nemocnica Martin	Martin	Slovakia
Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse	Ruse	Bulgaria
Specialized Hospital For Active Treatment Of Pneumo-Physiatiric Diseases Vraca /Sbalpfz Vratsa EOOD	Vratsa	Bulgaria
IKF Pneumologie GmbH & Co. KG	Frankfurt	Germany
MediTrial s.r.o.	Jindřichův Hradec	Czechia
Medical center Tara Ltd.	Veliko Tirnovo	Bulgaria
Medical Center New Rehabilitation Center EOOD	Stara Zagora	Bulgaria
Medical Center Pulmo-2018 EOOD	Haskovo	Bulgaria
Plicni Stredisko Teplice s.r.o.	Teplice	Czechia
Framol-Med GmbH	Rheine	Germany
POIS Sachsen GmbH	Leipzig	Germany
Salvus-Klinische Studien GmbH	Leipzig	Germany
Smo Md GmbH	Magdeburg	Germany
Multi-Profile Hospital For Active Treatment Dr. Stamen Iliev AD	Montana	Bulgaria
Velocity Clinical Research Luebeck GmbH	Luebeck	Germany
Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD	Sofia	Bulgaria
Medical Center Hera EOOD	Sofia	Bulgaria
Prvni plicni ambulance s.r.o.	Prague	Czechia
Synexus Polska Sp. z o.o.	Poznan	Poland
Medaimun GmbH	Frankfurt	Germany
Klifeck GmbH	Delitzsch	Germany
Institutul De Pneumoftiziologie Marius Nasta	Bucharest	Romania
Outpatient clinic group practice for specialized medical care for children’s diseases South Park OOD	Sofia	Bulgaria
University First multiprofile hospital for active treatment Sofia St. Joan Krastitel EAD	Sofia	Bulgaria
MUDr. I. Cierna Peterova s.r.o.	Brandys Nad Labem	Czechia
EMC Instytut Medyczny S.A.	Poznan	Poland
D A W O N spol. s r.o.	Prague	Czechia
Spitalul Clinic Nr.1 Cai Ferate Witting	Bucharest	Romania
Pclqaurofkv Vxqeuycje sopour	Varnsdorf	Czechia
Mjtjruh Csacsc Pafliq Cowupc Ecxt	Lovech	Bulgaria
Awfhdw smyeve	Kosice	Slovakia
Bxozkvhbjzlfy Fzfdqkau Wdcjdlu	Neu-Isenburg	Germany
Pwzpjlxo asixcvndcs Hnuwkznu snocss	Spisska Nova Ves	Slovakia
Shqasbyxhnejtw Dzw mhvu Srqwceahf	Peine	Germany
Mqqhyfa Ckskje Mwdpqzmngf Pnazzy Ooo	Pleven	Bulgaria
Scjwncru dv Pehfymozflb Dtf Lfppdgw Dijcurpmg Sdujb	Oradea	Romania
Cl Pspwau Bsjpmi Muw	Timisoara	Romania
Kxdi Gdam	Bendorf	Germany
Mkb Hukdhtmc Sg zht	Makow Podhalanski	Poland
Pjtazkeb Gnswnoo Ieqychksbeirdfvlvmhhqgcaflfmt Zivno Sgawgvvfop	Bialystok	Poland
Sklxpaei Camzce Dq Byuq Ispzpwtjvib Sk Pvokxoucimptbsutg Vtxjzt Bptcz Ctymuvg	Craiova	Romania
Pebyfwcc Ptwzfyvp Ltywjgga Gduenaf Pvaqdsxjnbbyicioaztkuypjfkl Ardt Pscqrlnlr	Bialystok	Poland

Trial status

Country	Status	Recruitment Start
Bulgaria	Recruiting	05.06.2025
Czechia	Recruiting	05.06.2025
Germany	Recruiting	05.06.2025
Poland	Recruiting	05.06.2025
Romania	Recruiting	05.06.2025
Slovakia	Recruiting	05.06.2025

Trial locations

Investigated drugs:

Fluticasone Propionate is a medication used to help control and prevent symptoms of asthma. It is a type of steroid that works by reducing inflammation in the airways, making it easier to breathe. In this trial, it is being tested to see how well it works on its own and in combination with another medication.

Albuterol Sulfate is a medication that helps to quickly relieve symptoms of asthma, such as wheezing and shortness of breath. It works by relaxing the muscles in the airways, allowing them to open up and make breathing easier. This trial is testing its effectiveness both alone and in combination with another medication.

Fluticasone Propionate/Albuterol Sulfate Combination is a combination of two medications used to treat asthma. The combination aims to provide both immediate relief from asthma symptoms and long-term control of inflammation in the airways. This trial is evaluating how effective this combination is compared to each medication used separately.

Asthma – Asthma is a chronic respiratory condition characterized by inflammation and narrowing of the airways, leading to difficulty in breathing. It often presents with symptoms such as wheezing, coughing, shortness of breath, and chest tightness. The progression of asthma involves episodes of exacerbation, where symptoms become more severe, often triggered by allergens, exercise, or respiratory infections. Over time, repeated inflammation can lead to structural changes in the airways, known as airway remodeling. This can result in a persistent reduction in lung function. Asthma symptoms can vary in frequency and intensity, and the condition requires ongoing management to control symptoms and prevent flare-ups.

Trial ID:

2024-517991-39-00

Protocol code:

FpA-AS-30093

NCT ID:

NCT06664619

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of Fluticasone Propionate and Salbutamol Sulfate for Asthma in Patients Aged 12 and Older

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?