Effect of PUR003 on Asthma

Phase 1

Completed

• Conditions: Asthma; Lung Diseases; Bronchial Diseases
• Interventions: Drug: Placebo; Drug: PUR003

• Registration Number: NCT00989521
• Lead Sponsor: Pulmatrix Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-02
• Study First Submitted QC: 2009-10-02
• Study First Posted: 2009-10-05
• Study Start: 2009-12
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-21
• Last Update Posted: 2011-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	normal saline for inhalation
PUR003	PUR003	PUR003 for inhalation

Primary Outcome Measures

Name	Time	Method
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.	after three doses

Trial Locations

Locations (1)

Firestone Institute for Respiratory Health; 🇨🇦 Hamilton, Ontario, Canada