Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2023-509001-76-00 | Other Identifier | EU CT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Salbutamol Test Arm | Experimental |
| |
| Salbutamol Reference Arm | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salbutamol HFA-134a | Drug | 100 microgram (μg) (ex-valve) at 30-second intervals per actuation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events (AEs) | Up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
Not provided
Inclusion Criteria:
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.
Asthma for ≥ 6 months, defined as:
Documented history of asthma, as defined by Global Initiative for Asthma (GINA) (GINA, 2023]
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:
Severity of disease assessed by the investigator by baseline pre-bronchodilator Forced expiratory volume in 1 second (FEV1)
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:
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.
Participants on as-needed SABA only, or daily maintenance ICS (plus as needed SABA):
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.
Who do not have a documented history of reversibility within the past 2 years will need to demonstrate reversibility during the screening period.
Participants on daily maintenance ICS/LABA or ICS/LABA/LAMA:
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.
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.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | North Hollywood | California | 91606-3287 | United States | ||
| GSK Investigational Site |
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
Not provided
Not provided
Not provided
Not provided
Not provided
| Salbutamol HFA-152a | Drug | 100 μg (ex-valve) at 30-second intervals per actuation |
|
| 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 | 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. | Baseline (Day 1) and up to 3 months |
| Change from baseline for pre-bronchodilator Forced expiratory volume in 1 second (FEV1) | Baseline (Day 1) and up to 3 months |
| San Mateo |
| California |
| 94403 |
| United States |
| GSK Investigational Site | Aventura | Florida | 33180 | United States |
| GSK Investigational Site | Clearwater | Florida | 33756 | United States |
| GSK Investigational Site | DeLand | Florida | 32720 | United States |
| GSK Investigational Site | Miami | Florida | 33144 | United States |
| GSK Investigational Site | Miami | Florida | 33155 | United States |
| GSK Investigational Site | Miami | Florida | 33173 | United States |
| GSK Investigational Site | Naples | Florida | 34102 | United States |
| GSK Investigational Site | Plantation | Florida | 33317 | United States |
| GSK Investigational Site | Winter Park | Florida | 32789 | United States |
| GSK Investigational Site | Rincon | Georgia | 31326 | United States |
| GSK Investigational Site | Stonecrest | Georgia | 30038 | United States |
| GSK Investigational Site | Louisville | Kentucky | 40217 | United States |
| GSK Investigational Site | Owensboro | Kentucky | 42301 | United States |
| GSK Investigational Site | Fall River | Massachusetts | 02723 | United States |
| GSK Investigational Site | Minneapolis | Minnesota | 55402 | United States |
| GSK Investigational Site | Minneota | Minnesota | 56001 | United States |
| GSK Investigational Site | Olive Branch | Mississippi | 38654 | United States |
| GSK Investigational Site | Columbia | Missouri | 65203 | United States |
| GSK Investigational Site | Henderson | Nevada | 89052 | United States |
| GSK Investigational Site | Jersey City | New Jersey | 07306 | United States |
| GSK Investigational Site | Riverdale | New Jersey | 07457 | United States |
| GSK Investigational Site | Brooklyn | New York | 11220 | United States |
| GSK Investigational Site | Asheville | North Carolina | 28803 | United States |
| GSK Investigational Site | Winston-Salem | North Carolina | 27104 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45231 | United States |
| GSK Investigational Site | Dublin | Ohio | 43016 | United States |
| GSK Investigational Site | Medford | Oregon | 97504 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15241 | United States |
| GSK Investigational Site | Pottstown | Pennsylvania | 19464 | United States |
| GSK Investigational Site | Rock Hill | South Carolina | 29732 | United States |
| GSK Investigational Site | Spartanburg | South Carolina | 29303 | United States |
| GSK Investigational Site | Union | South Carolina | 29379 | United States |
| GSK Investigational Site | Sugar Land | Texas | 77479 | United States |
| GSK Investigational Site | Tomball | Texas | 77375 | United States |
| GSK Investigational Site | Buenos Aires | C1425AZE | Argentina |
| GSK Investigational Site | Buenos Aires | C1425BEN | Argentina |
| GSK Investigational Site | Buenos Aires | C1426ABP | Argentina |
| GSK Investigational Site | La Plata | 1900 | Argentina |
| GSK Investigational Site | Mendoza | M5500CCG | Argentina |
| GSK Investigational Site | Botany | New South Wales | 2019 | Australia |
| GSK Investigational Site | Coffs Harbour | New South Wales | 2450 | Australia |
| GSK Investigational Site | Kanwal | New South Wales | 2259 | Australia |
| GSK Investigational Site | Spearwood | Western Australia | 6163 | Australia |
| GSK Investigational Site | Ajax | Ontario | L1S 2J5 | Canada |
| GSK Investigational Site | Brampton | Ontario | L6T 0G1 | Canada |
| GSK Investigational Site | Ottawa | Ontario | K1H 1E4 | Canada |
| GSK Investigational Site | Toronto | Ontario | M9V 4B4 | Canada |
| GSK Investigational Site | Windsor | Ontario | N8X 2G1 | Canada |
| GSK Investigational Site | Québec | Quebec | G1V 4W2 | Canada |
| GSK Investigational Site | Québec | Quebec | G1W 4R4 | Canada |
| GSK Investigational Site | Amiens | 80054 | France |
| GSK Investigational Site | Argenteuil | 95100 | France |
| GSK Investigational Site | Créteil | 94010 | France |
| GSK Investigational Site | Poitiers | 86021 | France |
| GSK Investigational Site | Pontoise | 95303 | France |
| GSK Investigational Site | Strasbourg | 67091 | France |
| GSK Investigational Site | Athens | 15669 | Greece |
| GSK Investigational Site | Larissa | 41110 | Greece |
| GSK Investigational Site | Thessaloniki | 57010 | Greece |
| GSK Investigational Site | Cagliari | 09042 | Italy |
| GSK Investigational Site | Florence | 50134 | Italy |
| GSK Investigational Site | Foggia | 71100 | Italy |
| GSK Investigational Site | Milan | 20162 | Italy |
| GSK Investigational Site | Naples | 80131 | Italy |
| GSK Investigational Site | Padova | 35128 | Italy |
| GSK Investigational Site | Roma | Italy |
| GSK Investigational Site | Torino | 10128 | Italy |
| GSK Investigational Site | Tradate VA | 21100 | Italy |
| GSK Investigational Site | Verona | 37134 | Italy |
| GSK Investigational Site | Panama City | 7002 | Panama |
| GSK Investigational Site | Panama City | 7099 | Panama |
| GSK Investigational Site | Panama City | Panama |
| GSK Investigational Site | Iloilo City | 5000 | Philippines |
| GSK Investigational Site | Bialystok | 15-010 | Poland |
| GSK Investigational Site | Bielsko-Biala | 43-300 | Poland |
| GSK Investigational Site | Chorzów | 41-500 | Poland |
| GSK Investigational Site | Elblag | 82-300 | Poland |
| GSK Investigational Site | Katowice | 40-600 | Poland |
| GSK Investigational Site | Ostrowiec Świętokrzyski | 27-400 | Poland |
| GSK Investigational Site | Płock | 09-407 | Poland |
| GSK Investigational Site | Tarnów | 33-100 | Poland |
| GSK Investigational Site | Barcelona | 08017 | Spain |
| GSK Investigational Site | Barcelona | 08540 | Spain |
| GSK Investigational Site | Benalmádena | 29631 | Spain |
| GSK Investigational Site | Madrid | 28031 | Spain |
| GSK Investigational Site | Madrid | 28040 | Spain |
| GSK Investigational Site | Madrid | 28041 | Spain |
| GSK Investigational Site | Marbella | 29603 | Spain |
| GSK Investigational Site | Pozuelo de AlarcOn Madr | 28223 | Spain |
| GSK Investigational Site | Pathum Thani | 12120 | Thailand |
| GSK Investigational Site | Bebington | CH63 9JP | United Kingdom |
| GSK Investigational Site | Cambridgeshire | CB7 5JD | United Kingdom |
| GSK Investigational Site | Corby | NN17 2UR | United Kingdom |
| GSK Investigational Site | Greater Manchester | OL6 6HD | United Kingdom |
| GSK Investigational Site | Guisborough | TS14 7DJ | United Kingdom |
| GSK Investigational Site | Hounslow | TW3 3EL | United Kingdom |
| GSK Investigational Site | Rhyl | LL18 4HZ | United Kingdom |
| GSK Investigational Site | Uttoxeter | ST14 5JX | United Kingdom |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided