allergic asthma and allergen-induced asthma MedDRA version: 9.1 Level: LLT Classification code 10001705 Term: Allergic asthma MedDRA version: 9.1 Level: LLT Classification code 10003638 Term: Atopic asthma
Conditions
Interventions
Product Code: TPI ASM8
Pharmaceutical Form: Nebuliser solution
Current Sponsor code: TOP 004
Concentration unit: % (W/V) percent weight/volume
Concentration type: equal
Concentration number: 50-
Curr
Sponsors
Topigen Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: ;Primary end point(s): 1. Safety • Vital signs include heart rate (preferably taken after a 10-15 min rest), respiratory rate, blood pressure, supine and standing and body temperature (oral or tympanic). Weight (kg) and height (cm) will be measured only at screening. • Adverse Events (AEs) & Serious Adverse Events (SAEs): An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation subject who receives a pharmaceutical product at any dose, whether or not there is a causal relationship with the investigational treatment. An AE could therefore be any unfavourable or unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. This definition includes intercurrent illnesses or injuries and exacerbation of pre-existing conditions. An unexpected AE is an AE not identified in nature, severity, or frequency in the current Investigator Brochure. An SAE is defined as any untoward medical occurrence that 1) results in death; 2) is life threatening (i.e., the subject was, in the opinion of the investigator, at immediate risk of death from the event as it occurred); 3) requires or prolongs hospitalization; 4) results in persistent or significant disability or incapacity (i.e., the event causes a substantial disruption of a person’s ability to conduct normal life functions); 5) is a congenital anomaly or birth defect in the offspring of the treated subject; and 6) is an important and significant medical event that, based upon appropriate medical judgment, may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes defining SAE. • Concomitant medications • Routine laborator | — |
Countries
Italy, United Kingdom
Outcome results
None listed