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

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.

Study Overview

• Status: Withdrawn
• Conditions: Asthma
• Intervention / Treatment: Drug: ASM8

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.

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Be diagnosed with asthma for 3 or more months Have moderate to severe asthma as defined by ATS criteria

Exclusion Criteria:

• No history of pulmonary or health problems for which the Investigator considers that participation in this protocol is a risk for the subject

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sputum total cells, differential and sputum levels of IL-1 and TNF alpha	Sputum total cells, differential (neutrophils, macrophages, bronchial cells and lymphocytes) and sputum levels of IL-1 and TNF alpha at the end of each treatment and at the final visit will be reported as absolute counts (10x6 cells/mL) and percentages (%) and change in % from baseline will also be presented.	56 days

Collaborators and Investigators

• Sponsor: Pharmaxis

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Anticipated): June 1, 2012
• Study Completion (Anticipated): May 1, 2013

Study Registration Dates

• First Submitted: June 22, 2011
• First Submitted That Met QC Criteria: June 23, 2011
• First Posted (Estimate): June 27, 2011

Study Record Updates

• Last Update Posted (Estimate): December 3, 2012
• Last Update Submitted That Met QC Criteria: November 29, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: ASM8-A-208