Asthma
Conditions
Keywords
Allergic asthma, Allergen challenge, Bronchial hyperresponsiveness
Brief summary
This study is designed to evaluate the effectiveness of nebulized IVX-0142, a novel anti-allergic drug, to inhibit allergen-induced airway narrowing in patients with allergic asthma and the related increased sensitivity of the airways to other substances, as well as to investigate a possible anti-inflammatory effect of the drug in the airways.
Interventions
DRUGNebulized IVX-0142
Sponsors
AllerGen NCE Inc.
Teva Branded Pharmaceutical Products R&D, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Mild stable allergic asthma * Positive skin-prick test to at least one common aeroallergen * Positive methacholine challenge * Positive allergen-induced early- and late-phase airway bronchoconstriction * General good health
Exclusion criteria
* Lung diseases other than mild allergic asthma * History or symptoms of cardiovascular disease, significant neurologic disease, and/or clinically significant autoimmune disease * Chronic use of asthma medications other than short or intermediate beta-agonists or ipratropium * Use of tobacco products within one year starting study or smoking history \>10 pack years * If female, pregnant or lactating or have positive pregnancy test at screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serial lung function tests measured up to 7 hours post-allergen challenge to assess effects on early- and late-phase asthmatic reactions | — |
Secondary
| Measure | Time frame |
|---|---|
| Methacholine PC20 pre- and post-allergen challenge | — |
| Anti-inflammatory activity in airways | — |
Countries
Canada
Outcome results
None listed