A single dose two-way cross-over study in healthy participants to compare the pharmacokinetics (PK) of salbutamol administered via metered dose inhalers containing propellants HFA-152a and HFA 134a

Completed

• Conditions: Asthma; 10010613

• Registration Number: NL-OMON53462
• Lead Sponsor: GlaxoSmithKline Research & Development Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2023-11-02
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1.Sex: male or female; females may be of childbearing potential, of
nonchildbearing potential, or postmenopausal
2. Age : 18 to 50 years, inclusive, at screening
3. BMI : 18.0 to 30.0 kg/m2, inclusive, at screening
4. Weight : >=50 kg
5. Status : healthy participants

Further criteria apply

Exclusion Criteria

1. 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;
constituting a risk when taking the study intervention or interfering with the
interpretation of data.
2. History or presence of any form of asthma, including childhood asthma and
exercise induced asthma.
3. Systolic blood pressure <90 mmHg or >140 mmHg, or diastolic blood pressure
<50 mmHg or >90 mmHg.
4. History of pathological tachycardia, or a pulse rate > 85 bpm at screening
or Day -1.
5. 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.

Further criteria apply

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To characterise the PK of single doses of salbutamol in healthy participants<br /><br>delivered via an MDI containing propellant HFA-152a, and to compare to<br /><br>an MDI containing propellant HFA-134a</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Pharmacokinetics: To characterise the PK of single doses of salbutamol in<br /><br>healthy participants delivered via an MDI containing propellant HFA-152a, and<br /><br>to compare to an MDI containing propellant HFA-134a<br /><br><br /><br>Pharmacodynamics (PD): To characterise the PD of single doses of salbutamol in<br /><br>healthy participants delivered via an MDI containing propellant HFA-152a, and<br /><br>to compare to an MDI containing propellant HFA-134a<br /><br><br /><br>Safety: To characterise the safety and tolerability of single doses of<br /><br>salbutamol in healthy participants delivered via an MDI containing propellant<br /><br>HFA-152a, and to compare to an MDI containing propellant HFA-134a</p><br>