Effect of PUR003 on Asthma

November 21, 2011 updated by: Pulmatrix Inc.

Double-blind, Placebo-controlled Crossover Evaluation of the Effect of PUR003 on Subjects With Asthma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • Firestone Institute for Respiratory Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
after three doses

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pulmatrix Inc.

Collaborators

McMaster University
St. Joseph's Healthcare Hamilton / Firestone Institute for Respiratory Health

Investigators

  • Principal Investigator: Parameswaran Nair, MD, PhD, St. Joseph's Healthcare Hamilton / Firestone Institute for Respiratory Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

October 2, 2009

First Submitted That Met QC Criteria

October 2, 2009

First Posted (Estimate)

October 5, 2009

Study Record Updates

Last Update Posted (Estimate)

November 22, 2011

Last Update Submitted That Met QC Criteria

November 21, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 601-1V2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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