NCT02162784

Efficacy Study of SYN006 HFA MDI in Asthma Patients

An Open-Label, Randomized, Cross-Over Study to Evaluate the Dose Response of SYN006 HFA MDI in Asthma Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Intech Biopharm Ltd. · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Three treatments will be administered in a patient: * A. Two inhalations of Ventolin 100 mcg, * B. One inhalation of SYN006 180/10 mcg, * C. Two inhalations of SYN006 180/10 mcg. Patients will be received the study treatment according to one of the six treatment sequences according to the randomization schedule: 1. A-B-C, 2. B-A-C, 3. C-A-B, 4. C-B-A, 5. A-C-B, 6. B-C-A. The efficacy endpoint is * The change in Forced Expiratory Volume in 1 second (FEV1) within 6 hours. * The change in Peak Expiratory Flow Rate (PEFR) within 6 hours. * The change in Force Vital Capacity (FVC) within 6 hours.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Budesonide/Procaterol, 180/10mcg X1	one puff
DRUG	Budesonide/procaterol 180/10 mcg X 2	2 puffs
DRUG	Albuterol HFA MDI 100mcg X2	HFA MDI, 100mcg, 2 puffs

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2014-06-13
• Last updated: 2015-06-03

Locations

3 sites across 1 country: Taiwan