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

NCT00822861 | Completed Phase 2 DMC

• 1 other identifier: TPI ASM8-206
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

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

  7 and 24 hrs post-allergen challenge

Secondary Outcomes (2)

• Safety and tolerability.

  Throughout the study

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

  Dose level 3 and 4

Study Arms (4)

Dose level No.1

EXPERIMENTAL

TPI ASM8 1 mg BID

Drug: TPI ASM8

Dose level No.2

EXPERIMENTAL

TPI ASM8 2 mg BID

Drug: TPI ASM8

Dose level No.3

EXPERIMENTAL

TPI ASM8 4mg BID

Drug: TPI ASM8

Dose level No.4

EXPERIMENTAL

TPI ASM8 8 mg Die

Drug: TPI ASM8

Interventions

TPI ASM8 DRUG

4 mg/mL, 1 mg BID for 4 days

Also known as: ASM8

Dose level No.1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Syntara: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

MeSH Terms

Conditions

Asthma

Interventions

TPI ASM8

Condition Hierarchy (Ancestors)

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

Study Officials

• Rene Pageau, B.Pharm M.Sc

  Topigen Pharmaceuticals Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2009
• First Posted: January 15, 2009
• Study Start: April 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: November 15, 2013

Record last verified: 2013-11

Locations

CA (1)