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OpenTrials
Completed

NCT Number: NCT00822861

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

About this study

The early and late asthmatic response were both significantly attenuated by the highest dose of ASM8. The methacholine challenge and other parameters (ECP, mRNA knockdown on CCR3 and B-Chain of IL-3-Il-5 and GMCSF were attenuated by ASM8.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

TPI ASM8

Drug

4 mg/mL, 1 mg BID for 4 days

Other names: ASM8

Primary outcomes

  1. Sputum eosinophils (%) on Day 4 versus Screening for each dose level.

    Time frame: 7 and 24 hrs post-allergen challenge

Secondary outcomes

  1. Safety and tolerability.

    Time frame: Throughout the study

  2. Plasma and sputum pharmacokinetic profile at the two highest dose levels.

    Time frame: Dose level 3 and 4

Sponsors and collaborators

Lead sponsor

Syntara

Industry

Registry information

Official study title

A Single Center, Open Label, Stepwise, Dose Profiling Study to Evaluate the Efficacy and Safety of Four Dose Regimens of Inhaled TPI ASM8 in Patients With Allergic Asthma

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 15, 2009
Registry last updated
Nov 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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