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

• Conditions: allergic asthma and allergen-induced asthma; MedDRA version: 9.1Level: LLTClassification code 10001705Term: Allergic asthma; MedDRA version: 9.1Level: LLTClassification code 10003638Term: Atopic asthma

• Registration Number: EUCTR2007-005094-54-GB
• Lead Sponsor: Topigen Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-26
• 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, (i.e.. 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;
• Positive 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 equal to or greater than 20% in FEV1 at 0-3 hrs following allergen challenge) and late (fall in FEV1 equal to or greater than 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;
• 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 ß2-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