Effect of PUR003 on Asthma

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00989521
• Other study ID #: 601-1V2
• Status: Completed
• Phase: Phase 1
• First received: October 2, 2009
• Last updated: November 21, 2011
• Start date: December 2009
• Est. completion date: October 2011

Study information

• Verified date: November 2011
• Source: Pulmatrix Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Bronchial Diseases
• Lung Diseases

Intervention

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

Locations

Country	Name	City	State
Canada	Firestone Institute for Respiratory Health	Hamilton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Pulmatrix Inc.	McMaster University, St. Joseph's Healthcare Hamilton / Firestone Institute for Respiratory Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes