a two-part study of the effects of mk-1029 in allergen-challenged asthmatics (mk-1029-003)

Conditions: Asthma

Summary: this was a 2-part study in participants with allergen-induced asthma. it included a procedural pilot component (part 1). part 1 tested the key procedures and timing of part 2; no study drug was administered during part 1. part 2 included a pre-randomization placebo run-in (period 1) and 3 treatment periods (periods 2, 3, and 4) during which participants were randomized to receive double-blind placebo, mk-1029 60 mg or mk-1029 500 mg in a crossover design. the treatment periods were followed by a minimum 21-day washout. part 2 assessed allergen-induced sputum eosinophils and allergen-induced late asthmatic response (lar) compared to placebo.


Eligibility criteria:
inclusion criteria: parts 1 and 2 * is male or a female of non-childbearing potential * has a history of allergen-induced asthma for at least 6 months * is judged to be in good health (other than asthma) * is able to perform reproducible pulmonary function testing * has a positive methacholine challenge test on day -1 * has an allergic response to house dust mite allergen as defined by positive skin prick test * is a nonsmoker and/ or has not used nicotine or nicotine-containing products for at least 12 months * has body mass index (bmi) ≥17 kg/m\^2, but ≤33 kg/m\^2 part 2 only * must demonstrate a dual airway response to an allergen challenge in period 1, decrease in fev1 of at least 20% 0 to 2 hours after allergen challenge for early asthmatic response (ear) and a positive late asthmatic response (lar) to an inhaled allergen challenge as defined by a bronchoconstrictive response of at least 15% reduction in fev1 3 to 8 hours after allergen challenge * can tolerate sputum induction and produce adequate sputum exclusion criteria: parts 1 and 2 * has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses additional risk to the participant * has recent (4 weeks) or ongoing upper or lower respiratory tract infection * is unable to refrain from or anticipates the use of any medication other than the ones permitted in this study * has taken oral, intramuscular, intra-articular, high-potency topical or orally inhaled corticosteroids within 8 weeks * has taken the following medications outside the washout margins: nasal corticosteroids and anti-leukotrienes within 3 weeks; inhaled long-acting β2-agonists, long-acting antihistamines (e.g., loratadine, sustained-release agents), intra-nasal anticholinergics over-the-counter decongestants within 1 week; short-acting oral decongestants, short-acting antihistamines (e.g., chlorpheniramine) within 48 hours * consumes excessive amounts of alcohol or caffeinated beverages * has had major surgery, donated or lost 1 unit of blood or participated in another investigational study within 3 months * has a history of severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food * is a nursing mother * has a history of receiving anti-immunoglobulin e (ige) or immunotherapy * has a history of serious allergies to drugs or a history of hypersensitivity to mometasone furoate or any of its inactive ingredients such as lactose, or inhaled salbutamol, antihistamines, or any other potential asthma/anaphylaxis rescue medication part 2 only - has a decline in fev1 of 70% or greater from the post allergen diluent baseline and/or fev1 \<1.0l or has symptomatic drop in fev1 associated with shortness of breath unresolved with bronchodilators within a reasonable timeframe (60 minutes) after the allergen challenge study in period 1