ClinicalTrials.Veeva

Menu

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

S

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

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

Trial contacts and locations

10

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems