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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01380236
Recruitment Status : Withdrawn (Protocol not progressed. Study not implemented.)
First Posted : June 27, 2011
Last Update Posted : December 3, 2012
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment Phase
Asthma Drug: ASM8 Phase 2

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  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2011
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Primary Outcome Measures :
  1. Sputum total cells, differential and sputum levels of IL-1 and TNF alpha [ Time Frame: 56 days ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Responsible Party: Pharmaxis Identifier: NCT01380236     History of Changes
Other Study ID Numbers: ASM8-A-208
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: December 3, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases