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
- Registration Number
- NCT06261957
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
The goal of this study is to assess and compare the safety and tolerability of salbutamol administered via metered dose inhaler (MDI) containing propellant 1,1-difluoroethane (HFA-152a) or 1,1,1,2-tetrafluoroethane (HFA-134a) in participants aged \>=18 years with asthma
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 412
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Participant of ≥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.
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Asthma for ≥ 6 months, defined as:
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Documented history of asthma, as defined by Global Initiative for Asthma (GINA) (GINA, 2023]
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Receiving one of the following asthma treatments, at a stable dose (applicable to daily Inhaled corticosteroid (ICS), ICS/Long-acting bronchodilator (LABA), and ICS/LABA/Long-acting muscarinic antagonist [LAMA]), for at least 12 weeks prior to the screening visit, with treatment that is anticipated to remain stable for the duration of the study:
- Short-Acting Beta-2-Adrenoreceptor Agonists (SABA) used as needed for asthma symptoms
- 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.
- Daily maintenance ICS/LABA/LAMA (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 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).
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Severity of disease assessed by the investigator by baseline pre-bronchodilator Forced expiratory volume in 1 second (FEV1)
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Asthma Control Status
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Asthma Control Questionnaire (ACQ) 6 score <1.5 at screening
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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.
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Evidence of reversibility of disease: Airway reversibility is defined as ≥12 percent (%) and ≥200 milliliter (mL) increase in FEV1 within 20 to 60 minutes following up to 4 inhalations of albuterol/salbutamol aerosol.
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Participants on as-needed SABA only, or daily maintenance ICS (plus as needed SABA):
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With a documented history of reversibility (as defined above) within 2 years will meet this inclusion criterion. Pre- and post-bronchodilator measurements will still be collected at screening to characterize the degree of reversibility.
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Who do not have a documented history of reversibility within the past 2 years will need to demonstrate reversibility during the screening period.
- SABA should be withheld for ≥6 hours
- Participants on daily maintenance ICS/LABA or ICS/LABA/LAMA:
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Participants on daily maintenance ICS/LABA or ICS/LABA/LAMA:
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Do not need to demonstrate reversibility in accordance with the above definition during the screening period. A reversibility maneuver will be performed to characterize the degree of post-bronchodilator change.
- SABA should be withheld for ≥6 hours
- LABA- and LAMA-containing medications should be withheld for >=24 hours for the characterization of post-bronchodilator change.
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Participants should be able to withhold SABA for ≥6 hours and LABA-/ LAMA containing medications for ≥24 hours for the purposes of performing screening spirometry.
- A history of life-threatening asthma or asthma that is unstable in the opinion of the investigator.
- 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.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Salbutamol Reference Arm Salbutamol HFA-134a - Salbutamol Test Arm Salbutamol HFA-152a -
- Primary Outcome Measures
Name Time Method Number of participants with Adverse Events (AEs) Up to 3 months
- Secondary Outcome Measures
Name Time Method Number of participants with Serious Adverse Events (SAEs) Up to 3 months Absolute Values of Minimum serum potassium (milliequivalents per litre [mEq/L]) Up to 3 months Absolute values of serum potassium (milligrams per decilitre) Up to 3 months Change from baseline in serum potassium (milligrams per decilitre) Baseline (Day 1) and up to 3 months Absolute value of haematology parameter: Platelet count (cells per microliter) Up to 3 months Absolute value of haematology parameter: Red Blood Cell Count (RBC) (million cells per microliter) Up to 3 months Absolute value of haematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters) Up to 3 months Absolute value of haematology parameter: Mean Corpuscle haemoglobin (MCH) (Picograms) Up to 3 months Absolute values of haematology parameter: Reticulocytes (Percentage of reticulocytes) Up to 3 months Absolute values of haematology parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre) Up to 3 months Absolute values of haematology parameter: haemoglobin (Hgb) (grams per decilitre) Up to 3 months Absolute values of haematology parameter: haematocrit (Proportion of red blood cells in blood) Up to 3 months Absolute values of Clinical Chemistry parameters: Glucose (non-fasting), Blood Urea Nitrogen (BUN), Creatinine, Sodium, Potassium, Calcium, Direct Bilirubin and Total Bilirubin (milligrams per decilitre) Up to 3 months Absolute values of Aspartate aminotransferase/serum glutamic-oxaloacetic transaminase, Alanine aminotransferase/serum glutamic-pyruvic transaminase, Alkaline phosphatase, Creatine phosphokinase (International Units per litre) Up to 3 months Absolute value of routine urinalysis: potential of hydrogen (pH) Up to 3 months Number of participants with abnormal urinalysis dipstick results: glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase Up to 3 months Change from baseline in haematology parameter: Platelet count (cells per microliter) Baseline (Day 1) and up to 3 months Change from baseline in haematology parameter: Red Blood Cell Count (RBC) (million cells per microliter) Baseline (Day 1) and up to 3 months Change from baseline in haematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters) Baseline (Day 1) and up to 3 months Change from baseline in haematology parameter: Mean Corpuscle haemoglobin (MCH) (Picograms) Baseline (Day 1) and up to 3 months Change from baseline in haematology parameter: Reticulocytes (Percentage of reticulocytes) Baseline (Day 1) and up to 3 months Change from baseline in haematology parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre) Baseline (Day 1) and up to 3 months Change from baseline in haematology parameter: haemoglobin (Hgb) (grams per decilitre) Baseline (Day 1) and up to 3 months Change from baseline in haematology parameters: haematocrit (Proportion of red blood cells in blood) Baseline (Day 1) and up to 3 months Change from baseline in Clinical Chemistry parameters: Glucose (non-fasting), Blood Urea Nitrogen (BUN), Creatinine, Sodium, Potassium, Calcium, Direct Bilirubin and Total Bilirubin (milligrams per decilitre) Baseline (Day 1) and up to 3 months Change from baseline in Aspartate aminotransferase/ serum glutamic-oxaloacetic transaminase,Alanine aminotransferase/serum glutamic-pyruvic transaminase, Alkaline phosphatase, Creatine phosphokinase (International Units per litre) Baseline (Day 1) and up to 3 months Change from baseline in routine urinalysis: pH Baseline (Day 1) and up to 3 months Absolute values for vital signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [millimeters of mercury (mm Hg)] Up to 3 months Absolute values for vital sign: pulse rate [beats per min (bpm)] Up to 3 months Change from baseline in vital signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [millimeters of mercury (mm Hg)] Baseline (Day 1) and up to 3 months Change from baseline in vital sign: pulse rate [beats per min (bpm)] Baseline (Day 1) and up to 3 months Absolute values for 12 Lead Electrocardiograms (ECGs) in Corrected QT interval (QTc) (milliseconds) Up to 3 months Absolute values for heart rate [beats per min (bpm)] Up to 3 months Change from baseline for 12 Lead ECGs in QTc (milliseconds) Baseline (Day 1) and up to 3 months Change from baseline for heart rate [beats per min (bpm)] Baseline (Day 1) and up to 3 months Change from baseline in Asthma Control Questionnaire (ACQ-6) score Baseline (Day 1) and up to 3 months ACQ-6 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation)) and a question on rescue bronchodilator use. A score of less than or equal to (\<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (\>=)1.5 indicates poorly controlled asthma.
Change from baseline for pre-bronchodilator Forced expiratory volume in 1 second (FEV1) Baseline (Day 1) and up to 3 months
Trial Locations
- Locations (1)
GSK Investigational Site
🇬🇧Uttoxeter, United Kingdom