Safety and Efficacy of Two Dosages of Inhaled TPI ASM8 Compared to Placebo in Mild to Moderate Asthmatic Patients

• Status: Terminated
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy, safety and tolerability of two dosages of a new drug TPI ASM8 administered by inhalation for 14 days to mild to moderate asthmatic patients, aged between 18-65, non-smokers . The study will also look at the nature and quantity of inflammatory white cells in the lung secretions and in the blood, and some additional inflammation markers.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmaxis

Criteria

Inclusion Criteria:

• Age 18-65 y. old, non or ex-smokers for > 6 months

• Mild to moderate asthmatic in general good health

• On either low-dose inhaled corticosteroid or steroid naive

• No other asthma medication

• Regular sputum producer

• EOS more than 3% at randomization,

• FEV1 > 70%

Exclusion Criteria:

• Respiratory infection within last 4 weeks

• Any condition that may affect the conduct of the study as per the investigators