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OpenTrials
Completed

NCT Number: NCT00989521

Effect of PUR003 on 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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Firestone Institute for Respiratory Health

Hamilton, Ontario, L8N 4A6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PUR003

Drug

PUR003 for inhalation

Placebo

Drug

Normal saline for inhalation

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Pulmatrix Inc.

Industry

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 5, 2009
Registry last updated
Nov 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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