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

Asthma Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00822861
• Other study ID #: TPI ASM8-206
• Status: Completed
• Phase: Phase 2
• First received: January 13, 2009
• Last updated: November 14, 2013
• Start date: April 2009
• Est. completion date: February 2010

Study information

• Verified date: November 2013
• Source: Pharmaxis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 ß2-agonist are allowed).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• TPI ASM8
4 mg/mL, 1 mg BID for 4 days
• TPI ASM8
4 mg/mL, 2 mg BID for 4 days
• TPI ASM8
4 mg/mL, 4 mg BID for 4 days
• TPI ASM8
4 mg/mL, 8 mg OD for 4 days

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Pharmaxis

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sputum eosinophils (%) on Day 4 versus Screening for each dose level.		7 and 24 hrs post-allergen challenge	No
Secondary	Safety and tolerability.		Throughout the study	Yes
Secondary	Plasma and sputum pharmacokinetic profile at the two highest dose levels.		Dose level 3 and 4	No