AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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.
Show all 27Show fewer
  • 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

Other trials in United States

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

Other trials in Italy

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

Other trials in Poland

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

Other trials in Spain

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

Other trials in United Kingdom

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

Other trials in Canada

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

Other trials in France

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

Other trials in Argentina

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

Other trials in Australia

Greece3 sites
  • GSK Investigational Site

    Athens, 15669

  • GSK Investigational Site

    Larissa, 41110

  • GSK Investigational Site

    Thessaloniki, 57010

Other trials in Greece

Panama3 sites
  • GSK Investigational Site

    Panama City, 7002

  • GSK Investigational Site

    Panama City, 7099

  • GSK Investigational Site

    Panama City

Other trials in Panama

Philippines1 site
  • GSK Investigational Site

    Iloilo City, 5000

Other trials in Philippines

Thailand1 site
  • GSK Investigational Site

    Pathum Thani, 12120

Other trials in Thailand

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 groups in NCT06261957
Study groupRoleWhat they receive
Salbutamol HFA-152a MDIExperimentalParticipants 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 MDIActive comparatorParticipants 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.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. Absolute Values of Minimum Serum Potassium

    Blood samples were collected to analyze minimum serum potassium.

    Measured: Up to Week 13 (Follow up)

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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)

  31. 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

  32. 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

  33. 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

  34. 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

  35. 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

  36. 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

  37. 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

  38. 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

  39. 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

  40. 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.

  1. First posted15 Feb 2024
  2. Study start31 May 2024
  3. Primary completion2 Sep 2025
  4. Study completion2 Sep 2025

Resources

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)
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
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

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in