A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, CROSSOVER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF 14-DAY INHALED TPI ASM8 IN SUBJECTS WITH ASTHMA - ND

• Conditions: asthma; MedDRA version: 9.1Level: LLTClassification code 10003553Term: Asthma

• Registration Number: EUCTR2007-005094-54-IT
• Lead Sponsor: TOPIGEN PHARMACEUTICALS INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Men and women 18 to 65 years of age; non-smoking, steroid-naive, (e.g. those who are not currently on corticosteroid or those who have not taken any oral/ inhaled/ ophthalmic or injectable corticosteroid within 60 days prior to start of the study); and generally in good health; Intermittent or persistent mild to moderate allergic asthma as defined by ATS/ ERS criteria ((American Thoracic Society Lung function testing, 1991); History of episodic wheeze and shortness of breath; Forced expiratory volume in 1 second (FEV1) at baseline at least 70% of the predicted value; Able to comprehend and follow all required study procedures; Willing and able to sign an REB/IEC-approved informed consent form; Subjects must not be taking any other regular anti-asthmatic medication except for the short-acting B2-agonist bronchodilator (e.g. salbutamol/albuterol) on an as needed basis; 5?AMP challenge at baseline (AMP-PC20 ≤ 60 mg/mL); Positive skin-prick test to at least one of common aeroallergens (including cat fur and dander, house dust mite, mixed grass pollen); Positive allergen-induced early (fall  20% in FEV1 at 0-3 hrs following allergen challenge) and late (fall in FEV1  15% at 3-7 hrs) airway response (Dual responders).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Significant acute or chronic medical, neurologic, cardiovascular or psychiatric illness; Known coagulopathy; Recent asthma exacerbation or respiratory infection in the preceding 6 weeks; Use of oral / injectable corticosteroids within the last 60 days or currently on any anti-asthmatic drugs, immunosuppressives, nonsteroidal anti-inflammatory drugs, or anticoagulants. (Intermittent doses of short-acting β2-agonist are allowed); Investigational drug use within 30 days; Any clinically significant abnormality on physical examination or on screening laboratory determinations; A >20% fall in FEV1 or FVC with baseline saline in the first AMP challenge during the screening period (Day ?14). Blood draws of 100 mL or more within 45 days prior to enrolment in the study. Ongoing use of tobacco products of any kind or previous usage within the past 12 months or past history of greater than or equal to 10 pack years Pregnant or lactating women; women actively seeking pregnancy or who are unwilling to use adequate contraception.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the efficacy and safety of multiple inhaled daily doses of TPI ASM8 in steroid-naïve asthmatic adults with atopy;Secondary Objective: To compare TPI ASM8 versus placebo using the following endpoints;Primary end point(s): Safety, Allergen-induced late airway response (LAR), maximum decrease in FEV1 (%) on Day 14.