Effect of PUR003 on Asthma

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00989521

Enrollment

Registered

2009-10-05

Start date

2009-12-31

Completion date

2011-10-31

Last updated

2011-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Bronchial Diseases, Lung Diseases

Keywords

Asthma, bronchial diseases, lung diseases, bronchitis, respiratory tract diseases

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.

Interventions

DRUGPUR003

PUR003 for inhalation

DRUGPlacebo

Normal saline for inhalation

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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.

Design outcomes

Primary

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.	after three doses

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026