AsthmaPhase 3NCT06261957
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
A Phase 3 study testing Salbutamol HFA-134a and Salbutamol HFA-152a in people with Asthma, run by GlaxoSmithKline at 102 sites in 13 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Salbutamol HFA-134a and Salbutamol HFA-152a
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 471 participants
- Where
- 102 sitesin 13 countries
- Study dates
- 31 May 2024to 2 Sep 2025
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
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- 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).
- 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:
- 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.
- 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.
- SABA should be withheld for ≥6 hours
- Participants on daily maintenance ICS/LABA or ICS/LABA/LAMA:
- 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.
- 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.
- 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.
Who cannot join
- 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.
Trial locations and contacts
102 sites in 13 countries.
102 sites in 13 countries
United States38 sites
GSK Investigational Site
Asheville, North Carolina, 28803
GSK Investigational Site
Aventura, Florida, 33180
GSK Investigational Site
Brooklyn, New York, 11220
GSK Investigational Site
Cincinnati, Ohio, 45231
GSK Investigational Site
Clearwater, Florida, 33756
GSK Investigational Site
Columbia, Missouri, 65203
GSK Investigational Site
DeLand, Florida, 32720
GSK Investigational Site
Dublin, Ohio, 43016
GSK Investigational Site
Fall River, Massachusetts, 02723-1511
GSK Investigational Site
Henderson, Nevada, 89052-5015
GSK Investigational Site
Jersey City, New Jersey, 07306
GSK Investigational Site
Louisville, Kentucky, 40217
GSK Investigational Site
Medford, Oregon, 97504
GSK Investigational Site
Miami, Florida, 33144
GSK Investigational Site
Miami, Florida, 33155
GSK Investigational Site
Miami, Florida, 33173
GSK Investigational Site
Minneapolis, Minnesota, 55402-2508
GSK Investigational Site
Minneota, Minnesota, 56001
GSK Investigational Site
Naples, Florida, 34102
GSK Investigational Site
North Hollywood, California, 91606-3287
GSK Investigational Site
Olive Branch, Mississippi, 38654
GSK Investigational Site
Owensboro, Kentucky, 42301
GSK Investigational Site
Philadelphia, Pennsylvania, 19107
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241
GSK Investigational Site
Plantation, Florida, 33317
GSK Investigational Site
Pottstown, Pennsylvania, 19464-3241
GSK Investigational Site
Rincon, Georgia, 31326-5131
GSK Investigational Site
Riverdale, New Jersey, 07457
GSK Investigational Site
Rock Hill, South Carolina, 29732
GSK Investigational Site
San Mateo, California, 94403
GSK Investigational Site
Spartanburg, South Carolina, 29303-4225
GSK Investigational Site
Spartanburg, South Carolina, 29303
GSK Investigational Site
Stonecrest, Georgia, 30038
GSK Investigational Site
Sugar Land, Texas, 77479
GSK Investigational Site
Tomball, Texas, 77375-3332
GSK Investigational Site
Union, South Carolina, 29379-7409
GSK Investigational Site
Winston-Salem, North Carolina, 27104
GSK Investigational Site
Winter Park, Florida, 32789-3385
Italy10 sites
GSK Investigational Site
Cagliari, 09042
GSK Investigational Site
Florence, 50134
GSK Investigational Site
Foggia, 71100
GSK Investigational Site
Milan, 20162
GSK Investigational Site
Naples, 80131
GSK Investigational Site
Padova, 35128
GSK Investigational Site
Roma, RM, 00161
GSK Investigational Site
Torino, 10128
GSK Investigational Site
Tradate VA, 21100
GSK Investigational Site
Verona, 37134
Poland8 sites
GSK Investigational Site
Bialystok, 15-010
GSK Investigational Site
Bielsko-Biala, 43-300
GSK Investigational Site
Chorzów, 41-500
GSK Investigational Site
Elblag, 82-300
GSK Investigational Site
Katowice, 40-600
GSK Investigational Site
Ostrowiec Świętokrzyski, 27-400
GSK Investigational Site
Płock, 09-407
GSK Investigational Site
Tarnów, 33-100
Spain8 sites
GSK Investigational Site
Barcelona, 08017
GSK Investigational Site
Barcelona, 08540
GSK Investigational Site
Benalmádena, 29631
GSK Investigational Site
Madrid, 28031
GSK Investigational Site
Madrid, 28040
GSK Investigational Site
Madrid, 28041
GSK Investigational Site
Marbella, 29603
GSK Investigational Site
Pozuelo de AlarcOn Madr, 28223
United Kingdom8 sites
GSK Investigational Site
Bebington, CH63 9JP
GSK Investigational Site
Cambridgeshire, CB7 5JD
GSK Investigational Site
Corby, NN17 2UR
GSK Investigational Site
Greater Manchester, OL6 6HD
GSK Investigational Site
Guisborough, TS14 7DJ
GSK Investigational Site
Hounslow, TW3 3EL
GSK Investigational Site
Rhyl, LL18 4HZ
GSK Investigational Site
Uttoxeter, ST14 5JX
Canada7 sites
GSK Investigational Site
Ajax, Ontario, L1S 2J5
GSK Investigational Site
Brampton, Ontario, L6T 0G1
GSK Investigational Site
Ottawa, Ontario, K1H 1E4
GSK Investigational Site
Québec, Quebec, G1V 4W2
GSK Investigational Site
Québec, Quebec, G1W 4R4
GSK Investigational Site
Toronto, Ontario, M9V 4B4
GSK Investigational Site
Windsor, Ontario, N8X 2G1
France6 sites
GSK Investigational Site
Amiens, 80054
GSK Investigational Site
Argenteuil, 95100
GSK Investigational Site
Créteil, 94010
GSK Investigational Site
Poitiers, 86021
GSK Investigational Site
Pontoise, 95303
GSK Investigational Site
Strasbourg, 67091
Argentina5 sites
GSK Investigational Site
Buenos Aires, C1425AZE
GSK Investigational Site
Buenos Aires, C1425BEN
GSK Investigational Site
Buenos Aires, C1426ABP
GSK Investigational Site
La Plata, 1900
GSK Investigational Site
Mendoza, M5500CCG
Australia4 sites
GSK Investigational Site
Botany, New South Wales, 2019
GSK Investigational Site
Coffs Harbour, New South Wales, 2450
GSK Investigational Site
Kanwal, New South Wales, 2259
GSK Investigational Site
Spearwood, Western Australia, 6163
Greece3 sites
GSK Investigational Site
Athens, 15669
GSK Investigational Site
Larissa, 41110
GSK Investigational Site
Thessaloniki, 57010
Panama3 sites
GSK Investigational Site
Panama City, 7002
GSK Investigational Site
Panama City, 7099
GSK Investigational Site
Panama City
About this study
Official title: A Randomized, Double-blind, Parallel Group, Multi-center Study to Evaluate the Long-term Safety of Salbutamol Rescue Medication When Administered Via Metered Dose Inhalers Containing the Propellant HFA-152a or Reference HFA-134a
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
- Conditions
- Asthma
- Being tested
- Salbutamol HFA-134a, Salbutamol HFA-152a
- Keywords
- Asthma, Salbutamol, MDI, HFA-152a, HFA-134a
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salbutamol HFA-134aDrug
100 microgram (μg) (ex-valve) at 30-second intervals per actuation
Salbutamol HFA-152aDrug
100 μg (ex-valve) at 30-second intervals per actuation
| Study group | Role | What they receive |
|---|---|---|
| Salbutamol HFA-152a MDI | Experimental | Participants with asthma received inhalation of 200 microgram (ug) (2*100 ug) or as needed up to maximum 800 µg once daily Salbutamol HFA-152a (Test) via metered dose inhaler (MDI) suspension at 30 second intervals per actuation. Participants attended 5 On-treatment visits at Weeks 0 (Day 1), 1, 4, 8 \& 12 and a Follow-up visit at Week 13. Receives: Drug: Salbutamol HFA-152a |
| Salbutamol HFA-134a MDI | Active comparator | Participants with asthma received inhalation of 200 microgram (ug) (2*100 ug) once daily plus as needed up to maximum 800 of µg Salbutamol HFA-134a (Reference) via metered dose inhaler (MDI) suspension at 30 second intervals per actuation. Participants attended 5 On-treatment visits at Weeks 0 (Day 1), 1, 4, 8 \& 12 and a Follow-up visit at Week 13. Receives: Drug: Salbutamol HFA-134a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs) During Run-in Period
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Measured: From Week -1 up to randomization (Day 1) during Run-in period
Number of Participants With Adverse Events (AEs) During Treatment Period
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Measured: From randomization (Day 1) up to Week 13 (Follow up) during treatment period
Secondary outcomes (40)
Number of Participants With Serious Adverse Events (SAEs) During Run-in Period
SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcomes (e.g., spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy), Is a suspected transmission of any infectious agent via an authorized medicinal product, other situations judged by physician, is associated with liver injury and impaired liver function. SAEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Measured: From Week -1 up to randomization (Day 1) during Run-in period
Number of Participants With Serious Adverse Events (SAEs) During Treatment Period
SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcomes (e.g., spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy), Is a suspected transmission of any infectious agent via an authorized medicinal product, other situations judged by physician, is associated with liver injury and impaired liver function. SAEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Measured: From randomization (Day 1) up to Week 13 (Follow up) during treatment period
Absolute Values of Minimum Serum Potassium
Blood samples were collected to analyze minimum serum potassium.
Measured: Up to Week 13 (Follow up)
Absolute Values of Serum Potassium at Each Assessed Visit
Blood samples were collected to analyze the serum potassium. Baseline value was defined as the pre-dose value on Day 1.
Measured: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Change From Baseline (CFB) in Serum Potassium at Each Assessed Visit
Blood samples were collected to analyze the serum potassium. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Measured: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Absolute Values of Hematology Parameter: Erythrocytes
Blood samples were collected to analyze the hematology parameter: Erythrocytes. Baseline value was defined as the pre-dose value on Day 1.
Measured: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Change From Baseline of Hematology Parameter: Erythrocytes
Blood samples were collected to analyze the hematology parameter: Erythrocytes. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Measured: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV)
Blood samples were collected to analyze the hematology parameter: MCV. Baseline value was defined as the pre-dose value on Day 1.
Measured: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Change From Baseline of Hematology Parameter: MCV
Blood samples were collected to analyze the hematology parameter: MCV. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Measured: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Blood samples were collected to analyze the hematology parameter: MCH. Baseline value was defined as the pre-dose value on Day 1.
Measured: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Change From Baseline of Hematology Parameter: MCH
Blood samples were collected to analyze the hematology parameter: MCH. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Measured: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Absolute Values of Hematology Parameter: Percentage of Reticulocytes
Blood samples were collected to analyze the hematology parameter: Percentage of Reticulocytes. Baseline value was defined as the pre-dose value on Day 1.
Measured: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Change From Baseline of Hematology Parameter: Percentage of Reticulocytes
Blood samples were collected to analyze the hematology parameter: Percentage of Reticulocytes. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Measured: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Blood samples were collected to analyze the hematology parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and platelets. Baseline value was defined as the pre-dose value on Day 1.
Measured: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Change From Baseline of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Blood samples were collected to analyze the hematology parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and platelets. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Measured: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Absolute Values of Hematology Parameter: Hemoglobin (Hgb)
Blood samples were collected to analyze the hematology parameter: Hgb. Baseline value was defined as the pre-dose value on Day 1.
Measured: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Change From Baseline of Hematology Parameter: Hemoglobin (Hgb)
Blood samples were collected to analyze the hematology parameter: Hgb. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Measured: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Absolute Values of Hematology Parameter: Hematocrit
Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline value was defined as the pre-dose value on Day 1.
Measured: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Change From Baseline of Hematology Parameter: Hematocrit
Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Measured: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Absolute Values of Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Urea and Glucose (Non-fasting)
Blood samples were collected to analyze the Clinical Chemistry parameters: Calcium, Potassium, Sodium, Urea and Glucose (non-fasting). Baseline value was defined as the pre-dose value on Day 1.
Measured: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Change From Baseline of Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Urea and Glucose (Non-fasting)
Blood samples were collected to analyze the Clinical Chemistry parameters: Calcium, Potassium, Sodium, Urea and Glucose (non-fasting). Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Measured: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin Total Bilirubin and Creatinine
Blood samples were collected to analyze the Clinical Chemistry parameters: Direct Bilirubin Total Bilirubin and Creatinine. Baseline value was defined as the pre-dose value on Day 1.
Measured: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Change From Baseline of Clinical Chemistry Parameters: Direct Bilirubin Total Bilirubin and Creatinine
Blood samples were collected to analyze the Clinical Chemistry parameters: Direct Bilirubin Total Bilirubin and Creatinine. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Measured: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Absolute Values of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)
Blood samples were collected to analyze the Clinical Chemistry Parameters: ALP, ALT, AST and CPK. Baseline value was defined as the pre-dose value on Day 1.
Measured: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Change From Baseline of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)
Blood samples were collected to analyze the Clinical Chemistry Parameters: ALP, ALT, AST and CPK. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Measured: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Absolute Value of Urinalysis Parameter: Potential of Hydrogen (pH)
Urine samples were collected to analyze the pH. Baseline value was defined as the pre-dose value on Day 1.
Measured: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Change From Baseline of Urinalysis Parameter: Potential of Hydrogen (pH)
Urine samples were collected to analyze the pH. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Measured: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Absolute Value of Urinalysis Parameter: Specific Gravity
Urine samples were collected to analyze the Specific Gravity. Baseline value was defined as the pre-dose value on Day 1.
Measured: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Change From Baseline of Urinalysis Parameter: Specific Gravity
Urine samples were collected to analyze the Specific Gravity. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Measured: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Number of Participants With Worst-case Urinalysis Results Post-baseline Relative to Baseline Urinalysis Dipstick Results: Occult Blood, Protein, Urobilinogen, Bilirubin, Glucose, Ketones, Leukocyte Esterase and Nitrite
Urinalysis parameters were assessed using standard Urinalysis dipsticks and categorized according to the semi-quantitative scale provided by the test strip manufacturer (e.g.,negative, trace, 1+,2+,3+,where applicable). For each parameter, worsening from baseline was defined as a shift from a lower category (Increased to TRACE \& Non-hemolyzed TRACE), to a higher category (Increased to 1+, 2+, 3+, 4+, or 1, 2,4, 8 mg/dL \& hemolyzed TRACE), indicating a greater degree of abnormality. The worst post-baseline category observed during the study was compared with the baseline category to derive a worst-case post-baseline change classification. Participants were categorized according to the magnitude of worsening observed (e.g.,No Change/Decreased, Increase to TRACE, Increase to 1+, Increase to 2+, etc., as applicable for the parameter assessed). Values that trend towards 'normal' or a lower category (i.e. from 2+ to 1+) indicates a shift towards /return to a negative result.
Measured: Up to Week 13 (Follow up)
Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SDP and DBP measurements were assessed with a completely automated device after the participant has been resting for at least 5 minutes in the supine position. Baseline value was defined as the pre-dose value on Day 1.
Measured: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP and DBP measurements were assessed with a completely automated device after the participant has been resting for at least 5 minutes in the supine position. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Measured: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Absolute Values for Vital Signs: Pulse Rate
Pulse rate measurements were assessed with a completely automated device after the participant has been resting for at least 5 minutes in the supine position. Baseline value was defined as the pre-dose value on Day 1.
Measured: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Change From Baseline in Vital Signs: Pulse Rate
Pulse rate measurements were assessed with a completely automated device after the participant has been resting for at least 5 minutes in the supine position. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Measured: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Absolute Values for 12 Lead Electrocardiograms (ECGs) in QT Interval Corrected by Fridericia's Formula (QTcF)
A standard 12-lead ECG was obtained using an ECG machine that automatically measures QTcF intervals. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures were averaged for QTc interval to derive one Baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Baseline was defined as the mean of the triplicate 12-lead ECG measurement from the Day 1 assessment (pre-dose).
Measured: Baseline (Day 1, mean of the pre-dose), Weeks 1, 4, 8, 12 and 13
Change From Baseline for 12 Lead ECGs in QTcF
A standard 12-lead ECG was obtained using an ECG machine that automatically measures QTcF intervals. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures were averaged for QTc interval to derive one Baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Baseline was defined as the mean of the triplicate 12-lead ECG measurement from the Day 1 assessment (pre-dose). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Measured: Baseline (Day 1, mean of the pre-dose), Weeks 1, 4, 8, 12 and 13
Absolute Values for Heart Rate
A standard 12-lead ECG was obtained using an ECG machine that automatically measures HR. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures were averaged for HR to derive one Baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Baseline was defined as the mean of the triplicate 12-lead ECG measurement from the Day 1 assessment (pre-dose).
Measured: Baseline (Day 1, mean of the pre-dose), Weeks 1, 4, 8, 12 and 13
Change From Baseline in Heart Rate
A standard 12-lead ECG was obtained using an ECG machine that automatically measures HR. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures were averaged for HR to derive one Baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Baseline was defined as the mean of the triplicate 12-lead ECG measurement from the Day 1 assessment (pre-dose). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Measured: Baseline (Day 1, mean of the pre-dose), Weeks 1, 4, 8, 12 and 13
Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score
The ACQ-6 measures 6 attributes of asthma control and are measured with a participant completed questionnaire. ACQ-6 consists of six questionnaires about the frequency and/or severity of symptoms (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath, wheeze and rescue medication use). Each question was scored from zero (no impairment/limitation) to six (total impairment/ limitation). The ACQ-6 score is calculated as the mean of the scores from the six questionnaire items. ACQ-6 score ranges from 0 to 6 with higher scores indicate greater impairment. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Measured: Baseline (Day 1, pre-dose) and Week 12
Change From Baseline for Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Forced Expiratory Volume in one second (FEV1) is defined as the volume of air forcibly exhaled in one second. Pre-bronchodilator FEV1 measurements were taken by spirometry. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.
Measured: Baseline (Day 1, pre-dose) and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start31 May 2024
- Primary completion2 Sep 2025
- Study completion2 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 471 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261957
- Sponsor's protocol ID
- 220735
- Other IDs
- 2023-509001-76-00, 2023
- Status last verified
- Sep 2026
- First submitted
- 8 Feb 2024
- Last updated
- 6 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf