ADO-5030 in Bronchoconstriction Challenge, Phase 1b

Korábbi kezelés

• Inability to refrain from using inhaled corticosteroids (ICS), cromolyn, long-acting-beta-agonists (LABA), and leukotriene modifiers (LT) for 48 hours.
• Any asthma exacerbation requiring oral corticosteroids within 12 months of screening or that resulted in overnight hospitalization or an urgent care visit requiring additional treatment for asthma.

Más betegség

• Any chronic medical condition considered by the PI as a contraindication to participation in the study including significant cardiovascular disease, uncontrolled diabetes, chronic renal disease, uncontrolled chronic thyroid disease, history of chronic infections or immunodeficiency.
• A positive history for HIV, TB, HBV, or HCV.
• Current smokers or a smoking history of ≥ 10 pack years. A subject may not have used any inhaled tobacco products in the 12-month period preceding Visit 1.
• Known allergy/sensitivity to theophylline.
• Any acute infection requiring antibiotics within 4 weeks or fever of unknown origin within 4 weeks of screening. Subjects having an intercurrent respiratory infection during the study will be permitted to reenroll.
• Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.

Egyéb

• Pregnancy or nursing a baby.
• Uncontrolled asthma at enrollment Visit 1 defined as ACT score <20.
• Unwillingness to use reliable contraception if sexually active (IUD, birth control pills/patch).

• Males and females ages 18-65 years, inclusive
• History of well-controlled mild or moderate persistent asthma for at least 6 months prior to screening.
• Well controlled asthma demonstrated by asthma control test (ACT) score ≥20 at Visit 1.
• Reactivity to AMP, as determined in Protocol 19512 (Screening Protocol of Asthmatic, Allergic Rhinitic, or Control Participants for Experimental Challenges). Reactivity is defined as having a PC20 AMP at or before 80mg/mL.
• Two replicable (within 2 dose doublings) AMP challenges. The two AMP challenges must occur within 28 days of each other.
• Pre-bronchodilator FEV1 ≥ 60% of predicted at screening.
• Normal or not clinically significant (NCS) safety laboratory results from Visit 1 prior to Visit 2.
• Negative pregnancy test for females who have not had a hysterectomy with oophorectomy or who have not been amenorrheic for 12 months or more.
• Willing to abstain from caffeine for 24 hours prior to each AMP challenge.
• Willing and able to give informed consent.