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

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: TPI ASM8

• Registration Number: NCT00822861
• Lead Sponsor: Syntara

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2009-01-13
• Study First Submitted QC: 2009-01-14
• Study First Posted: 2009-01-15
• Study Start: 2009-04
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-14
• Last Update Posted: 2013-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose level No.1	TPI ASM8	TPI ASM8 1 mg BID
Dose level No.2	TPI ASM8	TPI ASM8 2 mg BID
Dose level No.4	TPI ASM8	TPI ASM8 8 mg Die
Dose level No.3	TPI ASM8	TPI ASM8 4mg BID

Primary Outcome Measures

Name	Time	Method
Sputum eosinophils (%) on Day 4 versus Screening for each dose level.	7 and 24 hrs post-allergen challenge

Secondary Outcome Measures

Name	Time	Method
Plasma and sputum pharmacokinetic profile at the two highest dose levels.	Dose level 3 and 4
Safety and tolerability.	Throughout the study

Trial Locations

Locations (1)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada