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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)
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
Secondary ID [1] 0 0
2010-022391-31
Secondary ID [2] 0 0
1029-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Change From Baseline in Percent (%) Eosinophils in Induced Sputum At 8 Hours Post Allergen
Timepoint [1] 0 0
Baseline (Day -1) and Day 5 (8 hours after allergen challenge in each treatment period)
Primary outcome [2] 0 0
Forced Expiratory Volume in One Second (FEV1) From 3 to 8 Hours Postdose (AUC3-8hr) During the Late Asthmatic Response (LAR)
Timepoint [2] 0 0
From 3 to 8 hours after allergen challenge on Day 5 of each treatment period
Primary outcome [3] 0 0
Number of Participants With an Adverse Event (AE)
Timepoint [3] 0 0
Up to 26 days in each treatment period
Primary outcome [4] 0 0
Number of Participants Discontinuing Treatment Due to an AE
Timepoint [4] 0 0
Up to 5 days in each treatment period
Secondary outcome [1] 0 0
Percent Inhibition of the Expression of Cluster of Differentiation (CD)11b on Blood Eosinophils
Timepoint [1] 0 0
Baseline (Day -1, predose), 24 hours after allergen challenge on Day 5 in each treatment period

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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/04/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/01/2012
Sample size
Target
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01343407
Trial related presentations / publications
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

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries