Study Stopped
Protocol not progressed. Study not implemented.
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
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2011
Typical duration for phase_2 asthma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2011
CompletedFirst Posted
Study publicly available on registry
June 27, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedDecember 3, 2012
November 1, 2012
7 months
June 22, 2011
November 29, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- Be diagnosed with asthma for 3 or more months Have moderate to severe asthma as defined by ATS criteria
You may not qualify if:
- No history of pulmonary or health problems for which the Investigator considers that participation in this protocol is a risk for the subject
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Syntaralead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2011
First Posted
June 27, 2011
Study Start
November 1, 2011
Primary Completion
June 1, 2012
Study Completion
May 1, 2013
Last Updated
December 3, 2012
Record last verified: 2012-11