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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01380236
• Other study ID #: ASM8-A-208
• Status: Withdrawn
• Phase: Phase 2
• First received: June 22, 2011
• Last updated: November 29, 2012
• Start date: November 2011
• Est. completion date: May 2013

Study information

• Verified date: November 2012
• Source: Pharmaxis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• ASM8

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pharmaxis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes