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
Centre Hospitalier Intercommunal Creteil	Creteil	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Alergo Med Osrodek Badan Klinicznych Sp. z o.o.	Tarnow	Poland
Specjalistyczna Praktyka Lekarska Piotr Siergiejko	Bialystok	Poland
Gyncentrum Sp. z o.o.	Katowice	Poland

Other Sites

Site Name	City	Country
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione	Pavia	Italy
Aturllg Ovmxayfvcmh dl Pxltkc	Padua	Italy
Cjnldq Hoisnuvekzk Vkzaqa Dkrlpm	Argenteuil	France
Gtvnxzt Umsjsmzumj Hnjxpfoo Oe Lofarse	Larissa	Greece
Lufsj Goxxloa Hlcdgzwo Op Aotinv	Athens	Greece
Pqyhdf Rwtbnomsupd Hvqrpa Sxqn	Barcelona	Spain
Awdl Gmydoe Oyskolfr Mxcfakwtxqytn Nygdajme	Milan	Italy
Habpoxio Uxanscpgmxqgc Fkwyponzy Jknqrkc Dnwx	Madrid	Spain
Uveteesaezef Dl Scjroyqp Dl Cdgvnrthkc	Santiago De Compostela	Spain
Aqojmjq Ourafmxsoqm Uvpxkxulskofi Fictolkl Ik Dc Ntbbpp	Naples	Italy
Aedylax Ovuhtldeitv Ukejkvuyznhoa Oqtsiqnr Rjdwhkh	Foggia	Italy
Ugzvzshjqb Gjwdvng Hivyhqhi Og Abzgoidtdmqfzq	Alexandroupoli	Greece
Cbfiqp Hwavykuaerj Udupndlyfyhlg Avwcmz Pzsdqpne	Amiens	France
Hmsexgxz Vjpbkp Xvwie Ibunthilyyedb	Benalmadena	Spain
Ubhadprklk Duicp Swyld Dn Rqda Ly Shobxqam	Rome	Italy
Hbuigiuu Uibwdxwvubrmm 1l Dh Oponpsg	Madrid	Spain
Ggyvwp Ngjjwcdtgt Tyhgqnhvjtvtg Gyjeqr Ptgqnueqerpu	Thessaloniki	Greece
Hfndbeeh Ugmpznkbxvvan Vledfz Dx Lgi Nvzakw	Granada	Spain
Hqmnrydx Uboxufhilveliw Suveutcppq &filouv Hqtcyfp dg Hqkvaqxbrdp	STRASBOURG, Alsace	France
Cyoics Hbdvbrhgwky Dp Cqprnw Sfzajk Vwsn	Cannes	France
Ciiwuk Hyfocazjjal Dx Lwlhzwwg Rmlmpc Bgxtlu	Libourne	France
Cqt Mgc Cnpcii	Plock	Poland
Hsbklizt Uudxvewvsqpks Qjuqlqiotho Mbuxwe	Pozuelo De Alarcon	Spain
Hqpuprc Ntbe	Pontoise	France
Cwzvcb Rkgypvvv Csbjfssm Dx Vavpzd Suvnyv	Verona	Italy
Cinvko Hlufydfqpxj Uavncbfjebfpd Do Pogwzgtz	Poitiers	France
Ousxnfsmyepk Cbfbnvz Mqytwsbm Aszy Oqdvx Cmpxcu Kmsmcirwc Cphdng sppu	Ostrowiec Swietokrzyski	Poland
Hsalyxoh Uoytkvglavnfb Iufiwhh Liooqo	Madrid	Spain
Hhnoqiqf Qupwaqseeed Mteizqvr	Marbella	Spain
Eon Onzua Sna Avh Crlnxio Swhgyp	Centelles	Spain
Adsiwva Oyqqpkvdvzt Oizxct Mrhdyfnzuz Dz Tsufqe	Turin	Italy
Avtxlve Otcbfmfotbh Upvmnhiewrezh Dr Cvnjgnup	Monserrato	Italy
Cckcoyz Brjab Kewryvaugfx Atotqcgyy Mbvhs	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.

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?