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

Syntara

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: TPI ASM8

Study type: Interventional

Funder types: Industry

Identifiers

NCT00822861

TPI ASM8-206

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 4 patient groups

Dose level No.1

Experimental group

Description:

TPI ASM8 1 mg BID

Treatment:

Drug: TPI ASM8

Drug: TPI ASM8

Drug: TPI ASM8

Drug: TPI ASM8

Dose level No.2

Experimental group

Description:

TPI ASM8 2 mg BID

Treatment:

Drug: TPI ASM8

Drug: TPI ASM8

Drug: TPI ASM8

Drug: TPI ASM8

Dose level No.3

Experimental group

Description:

TPI ASM8 4mg BID

Treatment:

Drug: TPI ASM8

Drug: TPI ASM8

Drug: TPI ASM8

Drug: TPI ASM8

Dose level No.4

Experimental group

Description:

TPI ASM8 8 mg Die

Treatment:

Drug: TPI ASM8

Drug: TPI ASM8

Drug: TPI ASM8

Drug: TPI ASM8