Asthma Research Trial Testing Inhaler (30-58 Weeks)

Adolescents and adults at least 12 to 80 years of age with a history of physician-diagnosed asthma for 1 year or more, may qualify to participate in a study that will evaluate an investigational inhaler treatment for asthma. This inhaler contains a combination of three currently prescribed medications for asthma. The purpose of this study is to see whether this investigational inhaler treatment provides improved asthma control over other commonly prescribed asthma inhaler treatments.

Individuals must have regularly used a stable daily ICS/LABA (Inhaled Corticosteroid/Long-Acting β2-Agonist) regimen, for at least 4 weeks prior to screening. For adults 18+, a documented history of at least one asthma exacerbation requiring use of systemic corticosteroids (oral or IV) and any combination thereof for at least 3 consecutive days AND an associated physician visit, hospitalization, or ER visit due to asthma (within 3 days of the corticosteroid use) in the 12 months prior to screening, is also required.

Asthmatics with a medical history of any clinically significant disease that involves the heart, liver, kidneys, blood, nervous system, endocrine system, gastrointestinal tract, or lungs (such as active tuberculosis, bronchiectasis, pulmonary eosinophilic syndromes, and COPD) may not qualify. Current smokers, former smokers with a greater than 10 pack-years history, or former smokers who stopped smoking less than 6 months prior to screening (including all forms of tobacco, e-cigarettes or other vaping devices, and marijuana) need not apply.

Participants will receive an investigational inhaler treatment with three medications, OR an investigational inhaler treatment with two medications, OR an approved inhaler treatment. Study medication and study-related care will be provided at no cost. Reimbursement for study-related expenses will also be provided.

Study participation is variable (from 30 to 58 weeks) and will involve about 11 to 15 in-person visits to the study centre, plus a follow-up phone call.

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Why Take Part In a Clinical Study?

Regulatory agencies like Health Canada, Australia's Therapeutic Goods Administration and the FDA require that Clinical Research Trials be conducted in order to develop new treatments, preventions and devices for diseases or conditions. Clinical Research Trials are also referred to as Clinical Studies or Clinical Trials. read more