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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01343407
Registration number
NCT01343407
Ethics application status
Date submitted
26/04/2011
Date registered
28/04/2011
Date last updated
1/03/2019
Titles & IDs
Public title
A Two-part Study of the Effects of MK-1029 in Allergen-Challenged Asthmatics (MK-1029-003)
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Scientific title
A Two-Part, Multicenter, Randomized, Clinical Trial to Study the Effects of Multiple Doses of MK-1029 on the Late Asthmatic Response to Lung Allergen Challenge in Asthmatics
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Secondary ID [1]
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2010-022391-31
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Secondary ID [2]
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1029-003
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Asthma
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Condition category
Condition code
Respiratory
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Asthma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - MK-1029 10 mg
Treatment: Drugs - MK-1029 100 mg
Treatment: Drugs - Placebo for MK-1029 10 mg
Treatment: Drugs - Placebo for MK-1029 100 mg
Experimental: MK-1029 60 mg - Part 2 - Participants will receive 5 days of double-blind, once-daily MK-1029 60 mg followed by a 21-day washout in Period 2, 3, or 4 in a crossover design
Experimental: MK-1029 500 mg - Part 2 - Participants will receive 5 days of double-blind, once-daily MK-1029 60 mg followed by a 21-day washout in Period 2, 3, or 4 in a crossover design
Placebo Comparator: Placebo - Part II - Participants will receive 5 days of double-blind, once-daily MK-1029 60 mg followed by a 21-day washout in Period 2, 3, or 4 in a crossover design
Treatment: Drugs: MK-1029 10 mg
Six capsules once daily for 5 days in Period 2, 3, or 4 in a crossover design
Treatment: Drugs: MK-1029 100 mg
Five capsules once daily for 5 days in Period 2, 3, or 4 in a crossover design
Treatment: Drugs: Placebo for MK-1029 10 mg
Six capsules once daily for 5 days in Period 1, and the same in Period 2, 3, or 4 in a crossover design."
Treatment: Drugs: Placebo for MK-1029 100 mg
Five capsules once daily for 5 days in Period 2, 3, or 4 in a crossover design
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percent Change From Baseline in Percent (%) Eosinophils in Induced Sputum At 8 Hours Post Allergen
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Assessment method [1]
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The effect of MK-1029 on the reduction of percent (%) sputum eosinophils following allergen challenge with standardized cat pelt or hair (CPH) allergen extract was assessed. Baseline % eosinophils were measured before treatment (and pre-allergen challenge) on Day -1. The change from baseline in allergen-induced % sputum eosinophils at 8 hr post allergen challenge testing on Day 5 was analyzed using a repeated measures linear mixed effects model with treatment, period, time, time-by-treatment interaction as fixed factors, and participant as a random factor. Outcome Measure 6 shows % eosinophil values at baseline.
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Timepoint [1]
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Baseline (Day -1) and Day 5 (8 hours after allergen challenge in each treatment period)
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Primary outcome [2]
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Forced Expiratory Volume in One Second (FEV1) From 3 to 8 Hours Postdose (AUC3-8hr) During the Late Asthmatic Response (LAR)
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Assessment method [2]
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The effect of MK-1029 on the FEV1 AUC(3-8hr) during LAR was assessed. The unit of measure for an FEV1 AUC value is L*hr. The effect of treatment on LAR was assessed as the percent-fall in FEV1 AUC(3-8hr), evaluated by spirometry following allergen challenge on Day 5. The FEV1 AUC(3-8hr) during LAR was analyzed using a linear mixed effects model with treatment and period as fixed factors and participant as a random factor.
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Timepoint [2]
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From 3 to 8 hours after allergen challenge on Day 5 of each treatment period
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Primary outcome [3]
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Number of Participants With an Adverse Event (AE)
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Assessment method [3]
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The number of participants who had at least one adverse event (AE) during study treatment and follow-up was assessed. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product.
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Timepoint [3]
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Up to 26 days in each treatment period
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Primary outcome [4]
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Number of Participants Discontinuing Treatment Due to an AE
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Assessment method [4]
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The number of participants who discontinued study treatment due to an AE was assessed. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product.
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Timepoint [4]
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Up to 5 days in each treatment period
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Secondary outcome [1]
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Percent Inhibition of the Expression of Cluster of Differentiation (CD)11b on Blood Eosinophils
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Assessment method [1]
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The concentration of CD11b in whole blood samples was assessed. The percent-inhibition of CD11b (a cell-surface biomarker on activated eosinophils) was assessed following inhaled allergen challenge on Day 5. Inhibition of CD11b expression was assessed by analyzing the % inhibition of CD11b expression from baseline (Day -1) using a linear mixed-effects model with period, treatment, time, and treatment by time as fixed terms and subject as a random term. Outcome Measure 7 shows CD11b expression values at baseline.
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Timepoint [1]
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Baseline (Day -1, predose), 24 hours after allergen challenge on Day 5 in each treatment period
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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 ß2-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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/04/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
9/01/2012
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Sample size
Target
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Accrual to date
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Final
16
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Merck Sharp & Dohme LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01343407
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Medical Director
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Address
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Merck Sharp & Dohme LLC
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01343407
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