Skip to main content
OpenTrials
Completed

NCT Number: NCT06261957

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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).
  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Salbutamol HFA-134a

Drug

100 microgram (μg) (ex-valve) at 30-second intervals per actuation

Salbutamol HFA-152a

Drug

100 μg (ex-valve) at 30-second intervals per actuation

Primary outcomes

  1. Number of participants with Adverse Events (AEs)

    Time frame: Up to 3 months

Secondary outcomes

  1. Number of participants with Serious Adverse Events (SAEs)

    Time frame: Up to 3 months

  2. Absolute Values of Minimum serum potassium (milliequivalents per litre [mEq/L])

    Time frame: Up to 3 months

  3. Absolute values of serum potassium (milligrams per decilitre)

    Time frame: Up to 3 months

  4. Change from baseline in serum potassium (milligrams per decilitre)

    Time frame: Baseline (Day 1) and up to 3 months

  5. Absolute value of haematology parameter: Platelet count (cells per microliter)

    Time frame: Up to 3 months

  6. Absolute value of haematology parameter: Red Blood Cell Count (RBC) (million cells per microliter)

    Time frame: Up to 3 months

  7. Absolute value of haematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters)

    Time frame: Up to 3 months

  8. Absolute value of haematology parameter: Mean Corpuscle haemoglobin (MCH) (Picograms)

    Time frame: Up to 3 months

  9. Absolute values of haematology parameter: Reticulocytes (Percentage of reticulocytes)

    Time frame: Up to 3 months

  10. Absolute values of haematology parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre)

    Time frame: Up to 3 months

  11. Absolute values of haematology parameter: haemoglobin (Hgb) (grams per decilitre)

    Time frame: Up to 3 months

  12. Absolute values of haematology parameter: haematocrit (Proportion of red blood cells in blood)

    Time frame: Up to 3 months

  13. 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)

    Time frame: Up to 3 months

  14. Absolute values of Aspartate aminotransferase/serum glutamic-oxaloacetic transaminase, Alanine aminotransferase/serum glutamic-pyruvic transaminase, Alkaline phosphatase, Creatine phosphokinase (International Units per litre)

    Time frame: Up to 3 months

  15. Absolute value of routine urinalysis: potential of hydrogen (pH)

    Time frame: Up to 3 months

  16. Number of participants with abnormal urinalysis dipstick results: glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase

    Time frame: Up to 3 months

  17. Change from baseline in haematology parameter: Platelet count (cells per microliter)

    Time frame: Baseline (Day 1) and up to 3 months

  18. Change from baseline in haematology parameter: Red Blood Cell Count (RBC) (million cells per microliter)

    Time frame: Baseline (Day 1) and up to 3 months

  19. Change from baseline in haematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters)

    Time frame: Baseline (Day 1) and up to 3 months

  20. Change from baseline in haematology parameter: Mean Corpuscle haemoglobin (MCH) (Picograms)

    Time frame: Baseline (Day 1) and up to 3 months

  21. Change from baseline in haematology parameter: Reticulocytes (Percentage of reticulocytes)

    Time frame: Baseline (Day 1) and up to 3 months

  22. Change from baseline in haematology parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre)

    Time frame: Baseline (Day 1) and up to 3 months

  23. Change from baseline in haematology parameter: haemoglobin (Hgb) (grams per decilitre)

    Time frame: Baseline (Day 1) and up to 3 months

  24. Change from baseline in haematology parameters: haematocrit (Proportion of red blood cells in blood)

    Time frame: Baseline (Day 1) and up to 3 months

  25. 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)

    Time frame: Baseline (Day 1) and up to 3 months

  26. Change from baseline in Aspartate aminotransferase/ serum glutamic-oxaloacetic transaminase,Alanine aminotransferase/serum glutamic-pyruvic transaminase, Alkaline phosphatase, Creatine phosphokinase (International Units per litre)

    Time frame: Baseline (Day 1) and up to 3 months

  27. Change from baseline in routine urinalysis: pH

    Time frame: Baseline (Day 1) and up to 3 months

  28. Absolute values for vital signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [millimeters of mercury (mm Hg)]

    Time frame: Up to 3 months

  29. Absolute values for vital sign: pulse rate [beats per min (bpm)]

    Time frame: Up to 3 months

  30. Change from baseline in vital signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [millimeters of mercury (mm Hg)]

    Time frame: Baseline (Day 1) and up to 3 months

  31. Change from baseline in vital sign: pulse rate [beats per min (bpm)]

    Time frame: Baseline (Day 1) and up to 3 months

  32. Absolute values for 12 Lead Electrocardiograms (ECGs) in Corrected QT interval (QTc) (milliseconds)

    Time frame: Up to 3 months

  33. Absolute values for heart rate [beats per min (bpm)]

    Time frame: Up to 3 months

  34. Change from baseline for 12 Lead ECGs in QTc (milliseconds)

    Time frame: Baseline (Day 1) and up to 3 months

  35. Change from baseline for heart rate [beats per min (bpm)]

    Time frame: Baseline (Day 1) and up to 3 months

  36. Change from baseline in Asthma Control Questionnaire (ACQ-6) score

    Time frame: 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.

  37. Change from baseline for pre-bronchodilator Forced expiratory volume in 1 second (FEV1)

    Time frame: Baseline (Day 1) and up to 3 months

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 15, 2024
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.