A Two-part Study of the Effects of MK-1029 in Allergen-Challenged Asthmatics (MK-1029-003)

• Status: Completed
• Trial end date: 2012-01-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

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