drugset / Trial / NCT02162784

Efficacy Study of SYN006 HFA MDI in Asthma Patients

NCT02162784

Phase 2 Completed 39 enrolled Intech Biopharm Ltd.
RandomizedCrossoverOpen-labelTreatment

Summary

The objective of the study is to evaluate the dose response of SYN006 HFA MDI, which is a combination drug product of budesonide and procaterol hydrochloride, in asthma patients. Patients with mild to moderate asthma will be recruited. There will be two study medication administered in this study. The investigational medication is SYN006 (Budesonide/Procaterol hydrochloride, 180 mcg/10 mcg per inhalation) and the active comparative medication is Ventolin (Salbutamol sulfate 100 mcg per inhalation). The study medication will be administered by oral inhalation with the supervision of the investigator or a qualified staff.

Timeline

Start
2013-02
Primary completion
2014-08
Completion
2014-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Budesonide Small molecule 180 ug Inhaled
Subject Budesonide Small molecule 360 ug Inhaled
Subject Procaterol Other / unclassified 10 ug Inhaled
Subject Procaterol Other / unclassified 20 ug Inhaled
Comparator Salbutamol Unknown 200 ug Inhaled

Indications