A study to assess and compare safety and tolerability of 3 months treatment with salbutamol administered via MDI containing propellant HFA-152a or HFA-134a in participants =18 years of age with asthma
- Conditions
- AsthmaMedDRA version: 21.1Level: PTClassification code: 10006487Term: Bronchostenosis Class: 100000004855MedDRA version: 20.0Level: LLTClassification code: 10036654Term: Prevention Class: 10042613Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- CTIS2023-509001-76-00
- Lead Sponsor
- Glaxosmithkline Research & Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 412
Participant must be = 18 years of age at the time of signing the informed consent or written informed consent is obtained from each study participant’s legal guardian., Asthma for = 6 months, defined as: • Documented history of asthma, as defined by GINA (GINA, 2023] • 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: o Daily maintenance low to medium dose 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 SABA, which is anticipated to remain stable for the duration of the study. o Daily maintenance low to medium dose ICS/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. o Subjects who utilize combination budesonide/formoterol as reliever therapy, whether or not this is in addition to a SABA – are not eligible for screening. o Subjects 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)., Severity of disease: • Baseline pre-bronchodilator FEV1 =60% of predicted at screening. o Participants who are unable to perform the pre-bronchodilator FEV1 maneuvers at Visit 1 can, at the discretion of the investigator, attend the clinic once more after Visit 1 to attempt to perform the pre-bronchodilator FEV1 maneuvers again, as well as perform the post-bronchodilator FEV1 maneuvers for the assessment of reversibility (see Inclusion Criterion 5). This must be within 7 days of Visit 1. o Participants must meet Inclusion Criteria 3 and 5 to be eligible for the study. o Participants who provide a technically sound pre-bronchodilator FEV1 at Visit 1 which is not within the FEV1 inclusion limits cannot make another attempt and cannot be re-screened. o Should the participant successfully meet the requirements of Inclusion Criterion 3 at the second attempt then, provided that Inclusion Criterion 5 is met and all eligibility criteria assessed at Visit 1 are met, the participant may enter the run-in period. o Should the participant not successfully meet the requirements of Inclusion Criterion 3 at the second attempt then they will not be considered eligible for further study participation. o Refer to Section 8.3.4 for further information on pulmonary function testing., Asthma Control Status • 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: o Deterioration of asthma-requiring the use of systemic corticosteroids (tablets, suspension or injection), for at least 3 days, OR o An inpatient hospitalization or ED visit because of asthma, requiring systemic corticosteroids., Evidence of reversibility of disease: Airway reversibility is defined as =12% and =200 mL increase in FEV1 within 20 to 60 minutes of using an inhaled short acting beta-agonist. Spirometry will be performed after SABA is withheld for =6 hours and LABA-containing medications are held =24 hours. • Note: If the subject does not meet the above reversibility criteria at Visit 1 then the rever
A history of life-threatening asthma or asthma that is unstable in the opinion of the investigator. NOTE: Life-threatening asthma is defined as an asthma episode that required intubation/non-invasive positive pressure ventilation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures within the last 5 years., 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., 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., Asthma Exacerbation: Any severe asthma exacerbation within 6 months prior to screening, Any severe asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days, or a single depo injection or an in-patient hospitalization or ED visit due to asthma that required systemic corticosteroids., Participants must have had no more than 1 severe exacerbation during the 12 months prior to screening., Other concurrent diseases/abnormalities: A participant has any clinically significant or uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the participant at risk through study participation or would confound the interpretation of the study results if the condition/disease exacerbated during the study. (e.g., stroke or MI within 3 months, uncontrolled hypertension, congestive heart failure)., Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones), LAMA during the 3 months prior to the start of the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method