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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00822861

Enrollment

Registered

2009-01-15

Start date

2009-04-30

Completion date

2010-02-28

Last updated

2013-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

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.

Interventions

DRUGTPI ASM8

4 mg/mL, 1 mg BID for 4 days

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

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

Secondary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026