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

Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Groups, To Evaluate And Compare The Safety, Tolerability And Efficacy Of Two Dosages Of Inhaled TPI ASM8 Administered For 14 Days In Patients With Mild to Moderate Asthma.

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00402948

Enrollment

Registered

2006-11-23

Start date

2007-02-28

Completion date

2007-12-31

Last updated

2012-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

High eosinophils level in sputum

Brief 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.

Detailed description

See above

Interventions

DRUGTPI ASM8

0.25mg, 0.5mg for 14 days, daily dosage

DRUGASM8

inhalation 0.25mg daily for 14 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Sputum eosinophils at Day 1 and Day 14 and safety on Day 14	Prospective

Secondary

Measure	Time frame
FEV 1 on Day 1 and Day 14	Prospective
Rescue Medication (albuterol)for 21 days	Prospective
Gene expression ( mRNA, beta-chain and CCR3 on surface receptors of IL-3, IL-5 and GM-CSF	Prospective
Blood eosinophils at Day 0 and Day 15	Prospective

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026