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Phase 1 Completed N=16 Randomized Double-blind Treatment

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

Source: ClinicalTrials.gov NCT01343407 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcomePrimary: Percent Change From Baseline in Percent (%) Eosinophils in Induced Sputum At 8 Hours Post Allergen — -10.6; -7.3; 11.6 Percent change — p=0.011

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Percent Change From Baseline in Percent (%) Eosinophils in Induced Sputum At 8 Hours Post Allergen
-10.6; -7.3; 11.6 0.011 sig
PRIMARY
Forced Expiratory Volume in One Second (FEV1) From 3 to 8 Hours Postdose (AUC3-8hr) During the Late Asthmatic Response (LAR)
41.24; 49.76; 86.37 0.006 sig
PRIMARY
Number of Participants With an Adverse Event (AE)
11; 10; 11
PRIMARY
Number of Participants Discontinuing Treatment Due to an AE
0; 0; 1
SECONDARY
Percent Inhibition of the Expression of Cluster of Differentiation (CD)11b on Blood Eosinophils
89.9; 87.4; 4.1 <0.001 sig

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01343407). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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