Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
7 participants
INTERVENTIONAL
2009-12-31
2011-10-31
Brief Summary
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Study objectives are to :
1. to evaluate the safety of PUR003 in subjects with asthma, and
2. to evaluate the efficacy of PUR003 in assisting the treatment of asthma.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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placebo
normal saline for inhalation
Placebo
Normal saline for inhalation
PUR003
PUR003 for inhalation
PUR003
PUR003 for inhalation
Interventions
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PUR003
PUR003 for inhalation
Placebo
Normal saline for inhalation
Eligibility Criteria
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Inclusion Criteria
2. Ability and willingness to return to the outpatient clinic for repeated clinic visits and complete all assessments.
3. Adult male or female subject, 18-60 years of age.
4. Stable, mild asthma not requiring any medical treatment other than short acting inhaled bronchodilators, as needed.
5. No smoking within six months prior to entry
6. Must be medically stable.
7. Female subjects must have a negative pregnancy test
8. 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 Criteria
2. History of asthma exacerbations or upper or lower respiratory illness (viral respiratory syndrome, bronchitis, pneumonia) within four weeks of first visit.
3. Pregnancy, breastfeeding.
4. Abused alcohol or illicit drugs that required treatment.
5. Participated in any other investigational drug evaluation within last 30 days.
6. Scheduled to have elective or invasive medical intervention, procedure, or surgery within 6 months.
18 Years
60 Years
ALL
No
Sponsors
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St. Joseph's Healthcare Hamilton / Firestone Institute for Respiratory Health
UNKNOWN
McMaster University
OTHER
Pulmatrix Inc.
INDUSTRY
Responsible Party
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Firestone Institute for Respiratory Health
Principal Investigators
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Parameswaran Nair, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
St. Joseph's Healthcare Hamilton / Firestone Institute for Respiratory Health
Locations
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Firestone Institute for Respiratory Health
Hamilton, Ontario, Canada
Countries
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Other Identifiers
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601-1V2
Identifier Type: -
Identifier Source: org_study_id