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

This study has been withdrawn prior to enrollment.

(Protocol not progressed. Study not implemented.)

Sponsor:

Information provided by (Responsible Party):

Pharmaxis

ClinicalTrials.gov Identifier:

NCT01380236

First received: June 22, 2011

Last updated: November 29, 2012

Last verified: November 2012

History of Changes

Purpose

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	Intervention	Phase
Asthma	Drug: ASM8	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) 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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

U.S. FDA Resources

Further study details as provided by Pharmaxis:

Primary Outcome Measures:

Sputum total cells, differential and sputum levels of IL-1 and TNF alpha [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]
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.

Enrollment:	0
Study Start Date:	November 2011
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Pharmaxis
ClinicalTrials.gov Identifier:	NCT01380236 History of Changes
Other Study ID Numbers:	ASM8-A-208
Study First Received:	June 22, 2011
Last Updated:	November 29, 2012
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases

Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013

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