NCT01380236

A Single Blind Study to Evaluate the Safety, Tolerability and Explore the Efficacy of 8.0 mg ASM8 Inhaled Daily for 14 Days in Severe Asthma

A Phase II, Two-centre, Single Blind Study to Evaluate the Safety, Tolerability and Explore the Efficacy of 8.0 mg ASM8 Inhaled Daily for 14 Days in Adult Subjects With Moderate to Severe Asthma

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Syntara · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine the safety and tolerability of 8.0 mg of ASM8 when given daily for 14 days by the Aeroneb® Go nebulizer to subjects with moderate to severe asthma.

Detailed description

The safety and tolerability of ASM8 will be assessed by performing a physical exam and vital signs, measuring the use of concomitant medication, routine laboratory tests, urinalysis, sputum analysis, serum IL-1 and TNF-α, lung carbon monoxide diffusion capacity, pulse oximetry and measuring AEs There are 5 study phases: screening (phase 1), run-in (phase 2), treatment A (phase 3) with Active or Placebo, treatment B(phase 4) with Active or Placebo and end of study (phase 5) that includes a wash out period and a final visit.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	ASM8

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-06-01
• Completion: 2013-05-01
• First posted: 2011-06-27
• Last updated: 2012-12-03