Effect of PUR003 on Asthma

Pulmatrix

Status and phase: Completed; Phase 1

Conditions: Asthma; Lung Diseases; Bronchial Diseases

Treatments: Drug: Placebo; Drug: PUR003

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00989521

601-1V2

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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7 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

normal saline for inhalation

Treatment:

Drug: Placebo

PUR003

Active Comparator group

Description:

PUR003 for inhalation

Treatment:

Drug: PUR003