Study on the Safety of Salbutamol Inhalers with Propellants HFA-152a and HFA-134a for Adults with Asthma

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What is this study about?

This clinical trial is focused on studying the safety and tolerability of a medication called salbutamol sulfate, which is commonly used to treat asthma. Asthma is a condition that affects the airways in the lungs, making it difficult to breathe. The study will compare two different types of inhalers that deliver salbutamol: one using a new propellant called HFA-152a and the other using the standard propellant HFA-134a. Both inhalers are designed to help relieve asthma symptoms by opening up the airways.

The purpose of the study is to evaluate the long-term safety of these inhalers over a period of three months. Participants in the study will be randomly assigned to use one of the two inhalers. Some participants may receive a placebo, which looks like the real inhaler but does not contain the active medication. The study will be conducted in a way that neither the participants nor the researchers know which inhaler each participant is using, to ensure unbiased results.

Throughout the study, participants will use their assigned inhaler as needed for asthma relief. They will attend regular check-ups to monitor their health and any side effects they may experience. The study aims to provide valuable information on the safety of the new propellant in the inhalers, which could lead to improved treatment options for people with asthma.

1 Enrollment and Initial Assessment

Upon joining the study, eligibility is confirmed based on age (18 years or older) and a history of asthma for at least 6 months.

An initial assessment includes a lung function test to measure the forced expiratory volume (FEV1) to ensure it is at least 60% of the predicted value.

Asthma control is evaluated using the Asthma Control Questionnaire (ACQ) with a score below 1.5 indicating eligibility.

2 Run-in Period

Participants enter a run-in period to stabilize their asthma treatment. This involves maintaining a consistent dose of inhaled corticosteroids (ICS) or a combination of ICS and long-acting beta-agonists (LABA).

Participants must refrain from using short-acting beta-agonists (SABA) for at least 6 hours and LABA for 24 hours before spirometry tests.

3 Randomization and Treatment

Participants are randomly assigned to receive salbutamol via a metered dose inhaler (MDI) with either the test propellant HFA-152a or the reference propellant HFA-134a.

The treatment period lasts for 3 months, during which participants use the inhaler as a rescue medication for asthma symptoms.

4 Monitoring and Follow-up

Throughout the 3-month treatment period, participants are monitored for any adverse effects.

Regular follow-up visits are scheduled to assess the safety and tolerability of the treatment.

5 Completion of Study

At the end of the 3-month period, a final assessment is conducted to evaluate the overall safety and effectiveness of the treatment.

Participants complete the study and receive information on the results and any further steps if necessary.

Who Can Join the Study?

The participant must be at least 18 years old at the time of signing the informed consent, or a legal guardian must provide written consent for them.
The participant must have had asthma for at least 6 months. This means they should have a documented history of asthma and be receiving a stable dose of asthma treatment for at least 12 weeks before the study starts. The treatment should remain stable during the study.
The participant’s asthma should be controlled, with no severe worsening in the last 6 months. Severe worsening means needing systemic corticosteroids (medications taken by mouth, injection, or suspension) for at least 3 days, or needing to go to the hospital or emergency department because of asthma.
The participant must have a baseline lung function test result (called FEV1) that is at least 60% of what is predicted for their age and size. FEV1 is a measure of how much air a person can forcefully exhale in one second.
The participant must show evidence of airway reversibility. This means their FEV1 should increase by at least 12% and 200 mL within 20 to 60 minutes after using an inhaled short-acting beta-agonist (a type of asthma medication). If they don’t meet this requirement on the first try, they can try again within 7 days.
The participant should be able to avoid using short-acting beta-agonists for at least 6 hours and long-acting beta-agonists for at least 24 hours before lung function tests.

Who Cannot Join the Study?

Individuals under 18 years of age cannot participate.
People who do not have a diagnosis of asthma are excluded. Asthma is a condition where the airways in the lungs become narrow, making it hard to breathe.
Participants who are not able to use an inhaler properly are excluded. An inhaler is a device that helps deliver medicine directly into the lungs.
Individuals with other serious health conditions that might interfere with the study are not allowed to join.
Pregnant or breastfeeding women cannot participate in the study.
People who have participated in another clinical trial recently may be excluded.
Individuals with a known allergy to the study medication or its ingredients cannot take part.
Participants who are unable to follow the study procedures or attend scheduled visits are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
M2m Med. Sp. z o.o.	Chorzow	Poland
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Specjalistyczna Praktyka Lekarska Piotr Siergiejko	Bialystok	Poland
Alergo Med Osrodek Badan Klinicznych Sp. z o.o.	Tarnow	Poland
Centre Hospitalier Intercommunal Creteil	Creteil	France
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Gyncentrum Sp. z o.o.	Katowice	Poland
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France

Other Sites

Site Name	City	Country
Centre Hospitalier Victor Dupouy	Argenteuil	France
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Hospital Universitario 12 De Octubre	Madrid	Spain
Geniko Nosokomeio Thessalonikis George Papanikolaou	Thessaloniki	Greece
Hospital Universitario Infanta Leonor	Madrid	Spain
Hospital Quironsalud Marbella	Marbella	Spain
Eap Osona Sud Alt Congost S.L.P.	Centelles	Spain
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Azienda Ospedaliera Ordine Mauriziano Di Torino	Turin	Italy
Azienda Ospedaliera di Padova	Padua	Italy
Centre Hospitalier De Cannes Simone Veil	Cannes	France
General University Hospital Of Larissa	Larissa	Greece
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Hopital NOVO	Pontoise	France
University General Hospital Of Alexandroupoli	Alexandroupoli	Greece
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Hospital Vithas Xanit Internacional	Benalmadena	Spain
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione	Pavia	Italy
Azienda Ospedaliera Universitaria Di Cagliari	Monserrato	Italy
Olxqodvwdbtx Covzxlh Mzrwgzop Arfa Oczlg Cifygy Kdsbhmchx Ciaytt sxbm	Ostrowiec Swietokrzyski	Poland
Cqw Mqq Cqaaxc	Plock	Poland
Piyxxe Rpgiolpdoii Hcgnsk Sikd	Barcelona	Spain
Lgvvu Gerfhbs Hqcbgyzo Ox Angjnz	Athens	Greece
Awhvcsh Oedeopfoswh Utwjqkpunzjvj Opfrlpno Rbvrmlz	Foggia	Italy
Umyrspywlp Dbhcz Sajna Dp Reir Lb Sidyicgm	Rome	Italy
Hpzwkgwe Uuattzrgwwmsbc Skxgusgild &hljoxj Hieaqpo dl Htdsqbgteyt	STRASBOURG, Alsace	France
Cwcuoxb Bokgk Kdzdiepgogm Aylzxbpjw Mhpsa	Elblag	Poland

Trial status

Country	Status	Recruitment Start
France	Not recruiting	21.06.2024
Greece	Not recruiting	21.06.2024
Italy	Not recruiting	21.06.2024
Poland	Not recruiting	21.06.2024
Spain	Not recruiting	21.06.2024

Trial locations

Investigated drugs:

Salbutamol Sulfate

Salbutamol: This medication is used as a rescue treatment for asthma. It helps to quickly relieve symptoms such as wheezing, coughing, and shortness of breath by relaxing the muscles in the airways and improving airflow to the lungs. In this trial, salbutamol is administered using a metered dose inhaler (MDI) with two different types of propellants, HFA-152a and HFA-134a, to evaluate their long-term safety.

Investigated diseases:

Bronchostenosis

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. These symptoms can vary in intensity and may be triggered by factors like allergens, exercise, cold air, or stress. Asthma is marked by episodes of exacerbation, known as asthma attacks, where symptoms become more severe. The condition can affect individuals of all ages, but it often begins in childhood. Management typically involves avoiding triggers and using medications to control symptoms and prevent attacks.

Trial ID:

2023-509001-76-00

Protocol code:

220735

NCT ID:

NCT06261957

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Safety of Salbutamol Inhalers with Propellants HFA-152a and HFA-134a for Adults with Asthma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?