Effect of PUR003 on Asthma

This study has been completed.
Sponsor:
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
  Purpose

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 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:

  1. Signed written informed consent.
  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:

  1. History or presence of significant co-existing chronic diseases.
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014