GSK Investigational Site
Manchester, M23 9QZ, United Kingdom
Location status: Recruiting
Location contact
Dave Singh
PRINCIPAL_INVESTIGATOR
EU GSK Clinical Trials Call Centre
CONTACT
US GSK Clinical Trials Call Center
CONTACT
NCT Number: NCT06433921
The primary objectives of the study are: Part 1: to characterize the potency and variability of dose response on efficacy (Provocative concentration of methacholine causing at least a 20% fall in forced expiratory volume (FEV1) [PC20]) of salbutamol administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma. Part 2: to compare the comparative dose response on efficacy (PC20) of salbutamol when administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Phase 1
Manchester, M23 9QZ, United Kingdom
Location status: Recruiting
Dave Singh
PRINCIPAL_INVESTIGATOR
EU GSK Clinical Trials Call Centre
CONTACT
US GSK Clinical Trials Call Center
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
iii. Daily maintenance low-dose ICS + Long-acting beta-2 agonist (LABA) therapy (low-dose ICS defined as 100-250 μg/day fluticasone propionate or equivalent as defined by GINA [GINA, 2023]) plus or minus SABA, which is anticipated to remain stable for the duration of the study.
Exclusion criteria
A single 100, 200 or 400 μg dose, given as 1, 2 or 4 × 100 μg actuations (exvalve) at 20 second intervals.
A single 100, 200 or 400 μg dose, given as 1, 2 or 4 × 100 μg actuations (exvalve) at 20 second intervals.
A single placebo HFA-152a suspension or placebo HFA-134a suspension dose, given as at 20 second intervals.
Time frame: Up to 11 weeks
Time frame: Up to 11 weeks
Time frame: Up to 11 weeks
Time frame: Up to 11 weeks
Time frame: Up to 11 weeks
Time frame: Up to 11 weeks
Time frame: Up to 11 weeks
Time frame: Up to 11 weeks
Time frame: Up to 11 weeks
Time frame: Up to 11 weeks
Intervals recorded: - PR. - QRS. - QT. - QTc
Time frame: Baseline and up to 11 weeks
The 3 predose measures will be recorded and will be averaged for HR to derive 1 baseline value.
Time frame: Up to 11 weeks
The 3 predose measures will be recorded and will be averaged for QTc interval to derive 1 baseline value. Intervals recorded: - PR. - QRS. - QT. - QTc
Time frame: Up to 11 weeks
Time frame: Up to 11 weeks
Time frame: Up to 11 weeks
Contact information is provided by the study sponsor or research team.
EU GSK Clinical Trials Call Center
CONTACT
US GSK Clinical Trials Call Center
CONTACT
GlaxoSmithKline
Industry
A Phase 1, Randomized, 2-part, 7-way Cross-over (Part 1) and 7-way Cross-over (Part 2), Blinded, Single Dose Study in Mild Asthmatics Aged 18-65 to Assess the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers Containing Propellants HFA-152a (Test) and HFA-134a (Reference) Via Methacholine Bronchoprovocation and Systemic Pharmacodynamic Effects
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.
NCT04796844
Asthma, Bronchial Diseases
Genova, Italy
View Trial DetailsNCT00453778
Asthma, Bronchial Diseases
View Trial DetailsNCT00380354
Asthma, Bronchial Diseases
Manchester, Lancashire, United Kingdom
View Trial DetailsNCT07666490
Asthma, Bronchial Diseases
Rousse, Bulgaria
View Trial Details