Safety and Pharmacokinetics of Halix(TM) Albuterol Unit Dose Disposable Inhaler Versus Albuterol MDI

Asthma Clinical Trial

Official title: An Open-label, Single-Center, Single-Dose, 3-Way Crossover Study of the Safety and Pharmacokinetics of Albuterol Administered by the Halix(TM) Albuterol Unit Dose Disposable Inhaler

Status Completed

Clinical Trial Summary

Healthy male and female volunteers without asthma will be recruited to enroll in a single dose 3-way crossover study of the safety and pharmacokinetics of albuterol when administered using the Halix (TM) albuterol unit dose disposable dry powder inhaler (DPI) and the albuterol HFA (hydrofluoroalkane) MDI inhaler.

Clinical Trial Description

The study objective is to compare the safety of albuterol in a dry powder inhaler (DPI) and albuterol in an HFA metered dose inhaler (MDI) after single albuterol doses of 90mcg and 180mcg delivered by the DPI and 180mcg delivered by the MDI. Another study objective is to compare the pharmacokinetics (metabolism) of albuterol with the two inhalers in all subjects treated. To participate in the study, subjects must provide written informed consent, washout any prohibited medications and pass all the screening criteria. Once this is done, there will be 3 treatment visits for each subject. At each of these visits, the subject will inhale from either the DPI or the MDI. Assignment of subjects to one of six (6) unique sequences of treatment will be according to a randomized scheme. The subject will inhale albuterol either once from the DPI (90mcg), twice from the DPI (180mcg) and twice from the MDI (180mcg). Following inhalation of the study drug, there will be a series of assessments taken at times postdose with spirometry (FEV1) measured up to 2 hours postdose, vital signs measured up to 10 hours post dose, ECGs obtained up to 5 hours postdose, blood taken to measure potassium and glucose up to 6 hours postdose, and blood for pharmacokinetic evaluation obtained up to 10 hours postdose. A washout period of 60 to 192 hours will separate each of the 3 treatment visits. Following these visits, there will be a study concluding visit 3 to 10 days later. ;

Related Conditions & MeSH terms

• Asthma

• NCT number: NCT03373409
• Study type: Interventional
• Source: Concentrx Pharmaceuticals, Inc.
• Status: Completed
• Phase: Phase 1
• Start date: November 30, 2017
• Completion date: July 25, 2018