Efficacy and Safety of Four Escalating Dose Regimens of TPI ASM8 in Patients With Allergic Asthma

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

During this proposed clinical trial, the investigators intend to evaluate the pharmacodynamic anti-inflammatory properties and safety of TPI ASM8, by investigating the effect on sputum eosinophils and the airway responses during an allergen challenge at different dose levels.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pharmaxis

Criteria

Inclusion Criteria:

• Men and women 18 to 65 years of age

• Generally good health; steroid naïve (or who have not taken inhaled/oral corticosteroid within last month) mild to moderate, stable, allergic asthma as defined by ATS criteria

• History of episodic wheeze and shortness of breath

• Forced expiratory volume in one second (FEV1) at baseline ≥ 70% of the predicted value

• Able to comprehend and follow all required study procedures; willing and able to sign an informed consent form.

Exclusion Criteria:

• Significant acute or chronic medical or psychiatric illness

• Known coagulopathy, worsening of asthma or respiratory infection in the preceding 6 weeks

• Use of inhaled or oral corticosteroids within the last 30 days, or need for antihistamines within 72 hours of each allergen or methacholine challenge, immunosuppressives, nonsteroidal anti-inflammatory drugs, or anticoagulants (intermittent doses of short-acting β2-agonist are allowed).