Status:
COMPLETED
Effect of PUR003 on Asthma
Lead Sponsor:
Pulmatrix Inc.
Collaborating Sponsors:
St. Joseph's Healthcare Hamilton / Firestone Institute for Respiratory Health
McMaster University
Conditions:
Asthma
Lung Diseases
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
PUR003 is an inhaled substance that is proposed to assist in the treatment of asthma. Study objectives are to : 1. to evaluate the safety of PUR003 in subjects with asthma, and 2. to evaluate the ef...
Eligibility Criteria
Inclusion
- Signed written informed consent.
- Ability and willingness to return to the outpatient clinic for repeated clinic visits and complete all assessments.
- Adult male or female subject, 18-60 years of age.
- Stable, mild asthma not requiring any medical treatment other than short acting inhaled bronchodilators, as needed.
- No smoking within six months prior to entry
- Must be medically stable.
- Female subjects must have a negative pregnancy test
- Subjects of child bearing potential should be sexually inactive (abstinent) for 14 days prior to the first dose of study medication or using an acceptable form of birth control methods.
Exclusion
- History or presence of significant co-existing chronic diseases.
- History of asthma exacerbations or upper or lower respiratory illness (viral respiratory syndrome, bronchitis, pneumonia) within four weeks of first visit.
- Pregnancy, breastfeeding.
- Abused alcohol or illicit drugs that required treatment.
- Participated in any other investigational drug evaluation within last 30 days.
- Scheduled to have elective or invasive medical intervention, procedure, or surgery within 6 months.
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00989521
Start Date
December 1 2009
End Date
October 1 2011
Last Update
November 22 2011
Active Locations (1)
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1
Firestone Institute for Respiratory Health
Hamilton, Ontario, Canada, L8N 4A6