A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGlaxoSmithKline

About this trial

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.

Eligibility criteria

Qualifiers

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 (BMI) with 19.0-35.0 kg/m2 inclusive, at the time of screening.

Disqualifiers

Medical Conditions

A history of life-threatening asthma or asthma that is unstable in the opinion of the investigator.

A history of respiratory diseases to include (but not limited to): pneumothorax, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, cystic fibrosis, bronchiectasis, interstitial lung disease, emphysema, chronic obstructive pulmonary disease, tuberculosis, or other respiratory abnormalities other than asthma.

Asymptomatic gallstones.

Trial design

Treatments tested in this trial

  • Salbutamol HFA-152a
  • Salbutamol HFA-134a
  • Placebo

Treatment groups

84 Participants
are divided into 2 treatment groups

Sponsors and collaborators