Do you, or does your child suffer from inadequately controlled Asthma?
This clinical research study is looking at the safety and effectiveness of a medication for people with persistent asthma. Asthma is a condition in which your airways narrow and swell and may produce extra mucus. This can make breathing difficult and trigger coughing, a whistling sound (wheezing) when you breathe out, and shortness of breath.
The goal of this study is to assess and compare the safety and tolerability of salbutamol administered via metered dose inhaler (MDI) in participants aged 12 years and above with asthma.
Would you like to contribute to medical research?
As a volunteer in a research study, you’ll receive study-related medical care from the study doctor and regular follow-up of your asthma to monitor the effectiveness of the care you’ll receive. The results of this research will be used to find out if the investigational medication being studied will be of benefit to others with asthma, and whether it will be made widely available to all patients with asthma. Study volunteers are an important part of moving medical care forward.
You may qualify to participate in this study if you:
- Are a participant 12 years of age or older at the time of signing the informed consent, or written informed consent is obtained from each study participant’s legal guardian.
- Have been diagnosed with asthma for ≥ 6 months, defined as:
- Documented history of asthma, as defined by Global Initiative for Asthma (GINA)
- Receiving one of the following asthma treatments, at a stable dose, for at least 12 weeks prior to the screening visit, with treatment that is anticipated to remain stable for the duration of the study:
- Daily maintenance low to medium dose Inhaled corticosteroid (ICS) (low to medium dose ICS defined as 100-500 μg/day fluticasone propionate or equivalent as defined in the 2023 GINA guidelines [GINA, 2023], plus Short-Acting Beta-2-Adrenoreceptor Agonists (SABA), which is anticipated to remain stable for the duration of the study.
- Daily maintenance low to medium dose ICS/ Long-acting bronchodilator (LABA) (low to medium dose ICS defined as 100-500 μg/day fluticasone propionate or equivalent as defined in the GINA guidelines [GINA, 2023] plus SABA, which is anticipated to remain stable for the duration of the study.
- Participants who utilize combination budesonide/formoterol (e.g., Symbicort) as reliever therapy, whether or not this is in addition to a SABA – are not eligible for screening.
- Participants who utilize ICS/SABA combination therapy as reliever therapy, in addition to low to medium dose ICS or ICS/LABA as maintenance, are only eligible if they agree to discontinue their ICS/SABA inhaler for the duration of the study (screening through follow-up).
- Have asthma control status:
- Asthma Control Questionnaire (ACQ) 6 score <1.5 at screening
- Asthma that has remained stable with no severe exacerbations in the last 6 months. Severe exacerbation defined as:
- Deterioration of asthma-requiring the use of systemic corticosteroids (tablets, suspension or injection), for at least 3 days, OR
- An inpatient hospitalization or Emergency Department (ED) visit because of asthma, requiring systemic corticosteroids.
- Exhibit reversibility of disease evaluated by pulmonary function testing.
- Are able to withhold SABA for ≥6 hours and LABA-containing medications for ≥24 hours for the purposes of performing screening spirometry
You may not qualify to participate if you:
- Have a history of life-threatening asthma or asthma that is unstable in the opinion of the investigator.
- Have any other significant pulmonary diseases to include (but not limited to): pneumothorax, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, tuberculosis or other respiratory abnormalities other than asthma.
- Have any respiratory infection: Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of screening that led to a change in asthma management, OR in the opinion of the Investigator, is expected to affect the participant’s asthma status, OR the participant’s ability to participate in the study.
- Have had any severe asthma exacerbation within 6 months prior to screening.
- Have any current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones)
- Have any long-acting muscarinic antagonist (LAMA) during the 3 months prior to the start of the study.
- Have used any biologic/immunosuppressive therapies used for the treatment of respiratory diseases during the 6 months, or 5 half-lives-whichever is longer-prior to start of the study.
There are other eligibility requirements that the study doctor will review. Only the study doctor can finally determine whether you are eligible to participate in the study or not.
