RecruitingPhase 1interventionalRules rewrite

Phase 1: testing Salbutamol HFA-152a for Asthma

The primary objectives of the study are: Part 1: to characterize the potency and variability of dose response on how well it works (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 how well it works (PC20) of salbutamol when administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma.

Official registry: https://clinicaltrials.gov/study/NCT06433921 · GlaxoSmithKline · enrollment listed as 84

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Salbutamol HFA-152a, Salbutamol HFA-134a, or Placebo. The registry lists allocation as randomized. The primary objectives of the study are: Part 1: to characterize the potency and variability of dose response on how well it works (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.

They plan to enroll about 84 people at Manchester. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: Salbutamol HFA-152a, Salbutamol HFA-134a, Placebo

Primary outcome (registry wording): Part 1 & Part 2: Provocative concentration of methacholine causing at least a 20% fall in FEV1 (PC20)

Who it is for (from inclusion criteria)

Ages 18 Years to 65 Years
Male or female; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal
Participant must be 18 to 65 years of age inclusive, at the time of screening
≥50 kg, at the time of screening
Body mass index (body-mass index (BMI)) with 19.0-35.0 kg/m2 inclusive, at the time of screening
6\. No severe asthma exacerbations within 6 months prior to screening and ≤1 severe exacerbation during the 12 months prior to screening
10\. A female participant is eligible to participate if she is not pregnant or breastfeeding, and Is a woman of woman of nonchildbearing potential (WONCBP) OR ii. Is a woman of child bearing potential (WOCBP) and using a contraceptive method that is highly effective
12\. Non-smokers who have not used any tobacco containing-products within 12 months prior to study start, and with a total pack year history of ≤10 pack years

Who the registry excludes

A history of life-threatening asthma or asthma that is unstable in the opinion of the investigator
Asymptomatic gallstones
History or current evidence of hematologic, neurologic, psychiatric, or other diseases that, in the opinion of the investigator, would put the participant at risk through study participation, or would affect the study analyses if the disease exacerbates during the study
Recent eye surgery or any other condition in which raised intracranial pressure (caused by forceful exhalation) would be harmful
Current use of cholinesterase inhibitor medication e.g., to treat myasthenia gravis
Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day or participation in a clinical study within 30 days of study start, or 5 half-lives of study drug if that is longer
Participants who are currently or in the last 15 days have worked nightshifts

Public study contact (from the registry)

US GSK Clinical Trials Call Center

877-379-3718

GSKClinicalSupportHD@gsk.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

GSK Investigational Site — Manchester, Greater Manchester, United Kingdom (recruiting)

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FAQ about this NCT record

Is NCT06433921 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06433921?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06433921?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary