Efficacy Study of SYN006 HFA MDI in Asthma Patients

Asthma Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

• NCT number: NCT02162784
• Study type: Interventional
• Source: Intech Biopharm Ltd.
• Status: Completed
• Phase: Phase 2
• Start date: February 2013
• Completion date: August 2014