Effect of PUR003 on Asthma

NCT00989521 | Completed Phase 1

• 1 other identifier: 601-1V2
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

PUR003 is an inhaled substance that is proposed to assist in the treatment of asthma. Study objectives are to :

1. 1.to evaluate the safety of PUR003 in subjects with asthma, and
2. 2.to evaluate the efficacy of PUR003 in assisting the treatment of asthma.

Conditions

Asthma; Lung Diseases; Bronchial Diseases

Keywords

Asthma; bronchial diseases; lung diseases; bronchitis; respiratory tract diseases

Outcome Measures

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.

  after three doses

Study Arms (2)

placebo

PLACEBO COMPARATOR

normal saline for inhalation

Drug: Placebo

PUR003

ACTIVE COMPARATOR

PUR003 for inhalation

Drug: PUR003

Interventions

PUR003 DRUG

PUR003 for inhalation

PUR003

Placebo DRUG

Normal saline for inhalation

placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pulmatrix Inc.: lead
• St. Joseph's Healthcare Hamilton / Firestone Institute for Respiratory Health: collaborator
• McMaster University: collaborator

Study Sites (1)

Firestone Institute for Respiratory Health

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Asthma; Lung Diseases; Bronchial Diseases; Bronchitis; Respiratory Tract Diseases

Interventions

PUR003

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiratory Tract Infections; Infections

Study Officials

• Parameswaran Nair, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 2, 2009
• First Posted: October 5, 2009
• Study Start: December 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 22, 2011

Record last verified: 2011-11

Locations

CA (1)