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Effect of PUR003 on Asthma

Primary Purpose

Asthma, Lung Diseases, Bronchial Diseases

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
PUR003
Placebo
Sponsored by
Pulmatrix Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, bronchial diseases, lung diseases, bronchitis, respiratory tract diseases

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Firestone Institute for Respiratory Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

placebo

PUR003

Arm Description

normal saline for inhalation

PUR003 for inhalation

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
October 2, 2009
Last Updated
November 21, 2011
Sponsor
Pulmatrix Inc.
Collaborators
St. Joseph's Healthcare Hamilton / Firestone Institute for Respiratory Health, McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT00989521
Brief Title
Effect of PUR003 on Asthma
Official Title
Double-blind, Placebo-controlled Crossover Evaluation of the Effect of PUR003 on Subjects With Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pulmatrix Inc.
Collaborators
St. Joseph's Healthcare Hamilton / Firestone Institute for Respiratory Health, McMaster University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Lung Diseases, Bronchial Diseases
Keywords
Asthma, bronchial diseases, lung diseases, bronchitis, respiratory tract diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
normal saline for inhalation
Arm Title
PUR003
Arm Type
Active Comparator
Arm Description
PUR003 for inhalation
Intervention Type
Drug
Intervention Name(s)
PUR003
Intervention Description
PUR003 for inhalation
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Normal saline for inhalation
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parameswaran Nair, MD, PhD
Organizational Affiliation
St. Joseph's Healthcare Hamilton / Firestone Institute for Respiratory Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Firestone Institute for Respiratory Health
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada

12. IPD Sharing Statement

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Effect of PUR003 on Asthma

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