Effect of PUR003 on Asthma

Overview

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.

Full Title of Study: “Double-blind, Placebo-controlled Crossover Evaluation of the Effect of PUR003 on Subjects With Asthma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 2011

Interventions

  • Drug: PUR003
    • PUR003 for inhalation
  • Drug: Placebo
    • Normal saline for inhalation

Arms, Groups and Cohorts

  • Placebo Comparator: placebo
    • normal saline for inhalation
  • Active Comparator: PUR003
    • PUR003 for inhalation

Clinical Trial Outcome Measures

Primary 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pulmatrix Inc.
  • Collaborator
    • St. Joseph’s Healthcare Hamilton / Firestone Institute for Respiratory Health
  • Provider of Information About this Clinical Study
    • Parameswaran Nair, MD, PhD, FRCP, FRCPC, Firestone Institute for Respiratory Health
  • Overall Official(s)
    • Parameswaran Nair, MD, PhD, Principal Investigator, St. Joseph’s Healthcare Hamilton / Firestone Institute for Respiratory Health

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