Effect of PUR003 on Asthma
This study has been completed.
Sponsor:
Pulmatrix Inc.
Collaborators:
St. Joseph's Healthcare Hamilton / Firestone Institute for Respiratory Health
McMaster University
Information provided by:
Pulmatrix Inc.
ClinicalTrials.gov Identifier:
NCT00989521
First received: October 2, 2009
Last updated: November 21, 2011
Last verified: November 2011
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Purpose
PUR003 is an inhaled substance that is proposed to assist in the treatment of asthma.
Study objectives are to :
- to evaluate the safety of PUR003 in subjects with asthma, and
- to evaluate the efficacy of PUR003 in assisting the treatment of asthma.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma Lung Diseases Bronchial Diseases |
Drug: PUR003 Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Double-blind, Placebo-controlled Crossover Evaluation of the Effect of PUR003 on Subjects With Asthma |
Resource links provided by NLM:
Further study details as provided by Pulmatrix Inc.:
Primary Outcome Measures:
- Safety and tolerability of PUR003 as determined by incidence of adverse events (AEs); changes in physical examination, chest examination; pulmonary function; vital signs; electrocardiogram (ECG) and clinical laboratory assessments. [ Time Frame: after three doses ] [ Designated as safety issue: Yes ]
| Enrollment: | 7 |
| Study Start Date: | December 2009 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: placebo
normal saline for inhalation
|
Drug: Placebo
Normal saline for inhalation
|
|
Active Comparator: PUR003
PUR003 for inhalation
|
Drug: PUR003
PUR003 for inhalation
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00989521
Locations
| Canada, Ontario | |
| Firestone Institute for Respiratory Health | |
| Hamilton, Ontario, Canada, L8N 4A6 | |
Sponsors and Collaborators
Pulmatrix Inc.
St. Joseph's Healthcare Hamilton / Firestone Institute for Respiratory Health
McMaster University
Investigators
| Principal Investigator: | Parameswaran Nair, MD, PhD | St. Joseph's Healthcare Hamilton / Firestone Institute for Respiratory Health |
More Information
No publications provided
| Responsible Party: | Parameswaran Nair, MD, PhD, FRCP, FRCPC, Firestone Institute for Respiratory Health |
| ClinicalTrials.gov Identifier: | NCT00989521 History of Changes |
| Other Study ID Numbers: | 601-1V2 |
| Study First Received: | October 2, 2009 |
| Last Updated: | November 21, 2011 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Pulmatrix Inc.:
|
Asthma bronchial diseases lung diseases bronchitis respiratory tract diseases |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Lung Diseases Respiratory Tract Diseases Lung Diseases, Obstructive |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013