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Phase 1 N=30 Randomized Treatment

A Study to Compare the Pharmacokinetics (PK) of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152A (Test) or HFA-134A (Reference) in Healthy Participants Aged 18 to 55 Inclusive

Asthma · Healthy Participants

Enrolled (actual)
30
Serious AEs
0.8%
Results posted
Jan 2026
Primary outcome: Primary: Cohort 1: Area Under the Plasma Concentration-time Curve up to 30 Minutes Post- Dose (AUC[0-30]) — 156.41; 162.11 Hour * Picogram per Milliliter (h*pg/mL)

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
Salbutamol HFA-152a (Drug); Salbutamol HFA-134a (Drug)
Age
Adult · 18+ yrs
Sex
All
Sponsor
GlaxoSmithKline
Primary completion
Oct 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Cohort 1: Area Under the Plasma Concentration-time Curve up to 30 Minutes Post- Dose (AUC[0-30])
156.41; 162.11
PRIMARY
Cohort 1: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-infinity])
5734.92; 4431.63
PRIMARY
Cohort 1: Maximum Observed Plasma Concentration (Cmax)
639.28; 518.51
PRIMARY
Cohort 2: Area Under the Plasma Concentration-time Curve up to 30 Minutes Post- Dose (AUC[0-30])
443.33; 467.88
PRIMARY
Cohort 2: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-infinity])
17098.45; 14210.59
PRIMARY
Cohort 2: Maximum Observed Plasma Concentration (Cmax)
1891.30; 1677.79
SECONDARY
Cohort 1: Time to Reach Cmax (Tmax)
2.00; 2.0; 1.25; 1.00; 1.50; 1.50
SECONDARY
Cohort 1: Apparent Terminal Phase Half-life (t1/2)
7.83; 7.50; 7.62; 7.43; 7.92; 7.35
SECONDARY
Cohort 1: Area Under the Plasma Concentration-time Curve up to Last Time With Concentrations Above the Lower Limit of Quantification (LLOQ) (AUC[0-last])
5120.73; 3977.02
SECONDARY
Cohort 1-Intra-Participant Variability of AUC (0-30min)
36.3; 28.7
SECONDARY
Cohort 1: Intra Participant Variability of AUC (0-infinity)
28.3; 18.6
SECONDARY
Cohort 1: Intra Participant Variability of AUC(0-last)
28.5; 18.3
SECONDARY
Cohort 1: Intra Participant Variability of Cmax
33.5; 17.3
SECONDARY
Cohort 1: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
18; 12; 1; 0
SECONDARY
Cohort 1: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR)
55.1; 52.7; 63.1; 62.6; 53.6; 55.0
SECONDARY
Cohort 1: Absolute Values for 12 Lead ECGs Recording of QT Interval Corrected Using Fridericia's Formula (QTcF) Intervals
403.0; 411.6; 396.4; 402.4; 411.9; 399.0
SECONDARY
Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR
8.0; 10.0; 8.6; 7.8; 12.5; 5.7
SECONDARY
Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals
-6.6; -9.2; -11.5; -5.9; -8.9; -7.5
SECONDARY
Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count
3.62; 3.32; 3.05; 2.95; 2.07; 1.97
SECONDARY
Cohort 1: Absolute Values of Hematology Parameter: Erythrocytes
4.890; 5.158; 4.516; 4.753
SECONDARY
Cohort 1: Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV)
91.1; 92.1; 90.0; 91.6
SECONDARY
Cohort 1: Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
1.817; 1.845; 1.823; 1.841
SECONDARY
Cohort 1: Absolute Values of Hematology Parameter: Hemoglobin
143.19; 153.08; 132.77; 140.94
SECONDARY
Cohort 1: Absolute Values of Hematology Parameter: Hematocrit
0.445; 0.475; 0.405; 0.433
SECONDARY
Cohort 1: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)
21.67; 23.22; 19.33; 21.45; 65.4; 73.1
SECONDARY
Cohort 1: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine
4.12; 4.85; 3.79; 4.15; 12.2; 16.3
SECONDARY
Cohort 1: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen
2.388; 2.431; 2.300; 2.306; 139.7; 139.7
SECONDARY
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
4.76; 4.89; 4.97; 4.60; 4.86; 4.71
SECONDARY
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
108.6; 111.9; 109.9; 113.9; 112.2; 115.9
SECONDARY
Cohort 1: Absolute Values of Pulse Rate (PR)
55.7; 51.1; 63.9; 65.3; 61.9; 63.6
SECONDARY
Cohort 2: Time to Reach Cmax (Tmax)
1.50; 1.25; 1.50; 1.50; 1.50; 1.50
SECONDARY
Cohort 2: Apparent Terminal Phase Half-life (t1/2)
8.56; 7.73; 7.65; 7.79; 7.61; 7.57
SECONDARY
Cohort 2: Area Under the Plasma Concentration-time Curve up to Last Time With Concentrations Above the Lower Limit of Quantification (LLOQ) (AUC[0-last])
15345.11; 12840.80
SECONDARY
Cohort 2-Intra-Participant Variability of AUC (0-30min)
22.9; 25.8
SECONDARY
Cohort 2: Intra Participant Variability of AUC (0-infinity)
10.0; 8.6
SECONDARY
Cohort 2: Intra Participant Variability of AUC (0-last)
10.4; 9.0
SECONDARY
Cohort 2: Intra Participant Variability of Cmax
14.1; 12.2
SECONDARY
Cohort 2: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
20; 21; 0; 0
SECONDARY
Cohort 2: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR)
63.9; 53.2; 75.9; 66.4; 54.5; 61.4
SECONDARY
Cohort 2: Absolute Values for 12 Lead ECGs Recording of QTcF Intervals
407.8; 399.9; 400.8; 402.9; 398.9; 401.9
SECONDARY
Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR
12.0; 13.2; 12.2; 15.0; 11.6; 11.1
SECONDARY
Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals
-7.0; 3.0; 0.7; 0.0; 2.6; 5.1
SECONDARY
Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count
4.56; 3.11; 4.20; 2.81; 2.17; 2.01
SECONDARY
Cohort 2: Absolute Values of Hematology Parameter: Erythrocytes
5.028; 5.038; 4.575; 4.826
SECONDARY
Cohort 2: Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV)
89.8; 91.3; 90.3; 91.4
SECONDARY
Cohort 2: Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
1.834; 1.851; 1.837; 1.853
SECONDARY
Cohort 2: Absolute Values of Hematology Parameter: Hemoglobin
148.25; 149.95; 134.99; 143.73
SECONDARY
Cohort 2: Absolute Values of Hematology Parameter: Hematocrit
0.450; 0.458; 0.412; 0.440
SECONDARY
Cohort 2: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)
19.15; 23.88; 21.22; 25.63; 64.1; 62.6
SECONDARY
Cohort 2: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine
3.75; 4.68; 3.58; 4.18; 16.7; 16.1
SECONDARY
Cohort 2: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen
2.422; 2.388; 2.313; 2.341; 138.8; 139.1
SECONDARY
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
4.84; 4.99; 5.04; 4.96; 5.08; 4.96
SECONDARY
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
109.9; 108.3; 114.9; 113.8; 114.6; 113.8
SECONDARY
Cohort 2: Absolute Values of Pulse Rate (PR)
62.1; 51.3; 75.8; 67.7; 75.8; 64.0

Summary

The primary objective of the study is to characterize the PK of single doses of salbutamol in healthy participants delivered via an MDI containing propellant HFA-152a (test), and to compare with an MDI containing propellant HFA-134a (reference).

Eligibility Criteria

Inclusion Criteria

  • Sex: male or female; females may be of childbearing potential, of nonchild bearing potential, or postmenopausal.
  • Age: 18 to 55 years inclusive.
  • Weight: 45 to 110 kg inclusive
  • Status: healthy participants.
  • Females must not be pregnant or lactating.
  • All prescribed medication must have been stopped at least 30 days prior to admission to the clinical research center based on investigator judgment. An exception is made for hormonal contraceptives, which may be used throughout the study.
  • All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (e.g., St. John's wort) must have been stopped at least 14 days prior to admission to the clinical research center based on investigator judgment. An exception is made for acetaminophen, which is allowed up to admission to the clinical research center.
  • Ability and willingness to abstain from alcohol from 48 hours (2 days) prior to screening, and from 48 hours (2 days) prior to admission until discharge from the clinical research center.
  • Ability and willingness to abstain from methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks) from 48 hours (2 days) prior to admission until discharge from the clinical research center.
  • Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the investigator.
  • Serum potassium and serum glucose levels within reference ranges of the clinical research center.
  • Willing and able to sign the informed consent form.
  • Spirometry at screening demonstrating forced expiratory volume ≥80% predicted.

Exclusion Criteria

  • History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs.
  • History or presence of any form of asthma, including childhood asthma and exercise induced asthma.
  • At screening, systolic blood pressure 140 mmHg, or diastolic blood pressure 90 mmHg.
  • History of pathological tachycardia, or a pulse rate > 85 beats per minute (bpm) at screening or Day-1.
  • Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
  • Breast cancer within the past 10 years.
  • A QTcF value of >450 msec at screening based on a triplicate measurement taken at a single timepoint.
  • Vaccine(s) within 2 weeks prior to admission, or plans to receive such vaccines during the study.
  • Donation or loss of more than 450 mL of blood within 60 days prior to (the first) drug administration. Donation or loss of more than 1.5 L of blood (for male participants) or more than 1.0 L of blood (for female participants) in the 10 months prior to (the first) drug administration in the current study.
  • Participation in a drug study within 30 days prior to (the first) drug administration in the current study. Participation in 4 or more other drug studies in the 12 months prior to (the first) drug administration in the current study.
  • Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • Presence of hepatitis B surface antigen at screening or within 3 months prior to first dose of study intervention.
  • Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention. NOTE: Participants with positive hepatitis C antibody test result due to prior resolved disease can be enrolled if a confirmatory negative hepatitis C RNA test is obtained.
  • Positive pre-study drug/alcohol screen, including tetrahydrocannabinol.
  • Positive HIV antibody test.
  • Cotinine levels indicative of smoking or history or use
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06433908). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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