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

Syntara

Status and phase: Terminated; Phase 2

Conditions: Asthma

Treatments: Drug: TPI ASM8; Drug: ASM8

Study type: Interventional

Funder types: Industry

Identifiers

NCT00402948

TPI ASM8 -204

Details and patient eligibility

About

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.

Full description

See above

Enrollment: 10 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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10 participants in 2 patient groups

TPI ASM8

Experimental group

Description:

ASM8 0.25mg

Treatment:

Drug: TPI ASM8

ASM8 as TPI ASM8

Experimental group

Description:

TPI ASM8 0.5mg

Treatment:

Drug: ASM8