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Effect of PUR003 on Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00989521
Recruitment Status : Completed
First Posted : October 5, 2009
Last Update Posted : November 22, 2011
Sponsor:
Collaborators:
Information provided by:

Study Description
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 efficacy of PUR003 in assisting the treatment of asthma.

Condition or disease Intervention/treatment Phase
Asthma Lung Diseases Bronchial Diseases Drug: PUR003 Drug: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind, Placebo-controlled Crossover Evaluation of the Effect of PUR003 on Subjects With Asthma
Study Start Date : December 2009
Primary Completion Date : October 2011
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: placebo
normal saline for inhalation
Drug: Placebo
Normal saline for inhalation
Active Comparator: PUR003
PUR003 for inhalation
Drug: PUR003
PUR003 for inhalation


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: October 5, 2009    Key Record Dates
Last Update Posted: November 22, 2011
Last Verified: November 2011

Keywords provided by Pulmatrix Inc.:
Asthma
bronchial diseases
lung diseases
bronchitis
respiratory tract diseases

Additional relevant MeSH terms:
Asthma
Lung Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases