Phase-II Study of MK-1029 added to Montelukast in Adults with Uncontrolled Asthma.

• Register: EUCTR
• Last refreshed on: 22 January 2018
• Main ID: EUCTR2015-005054-36-PL
• Date of registration: 11/07/2016
• Prospective Registration: Yes
• Primary sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
• Public title: Phase-II Study of MK-1029 added to Montelukast in Adults with Uncontrolled Asthma.
• Scientific title: A Phase-II, Randomized, Placebo-Controlled, Parallel-Group Clinical Trial to Study the Efficacy and Safety of MK-1029 in Adult Subjects with Persistent Asthma That is Uncontrolled While Receiving Montelukast. - Phase-II Study of MK-1029 added to Montelukast in Adults with Uncontrolled Asthma
• Date of first enrolment: 22/08/2016
• Target sample size: 100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-005054-36
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Guatemala, Japan, Malaysia, Poland, South Africa

Contacts

• Name: Global Clinical Trials Operations

• Name: Global Clinical Trials Operations

Key inclusion & exclusion criteria

Inclusion criteria:
•Male/Female subjects between the ages of 18 and 65
•Have a consistent clinical history, for at least one year, of symptoms of persistent asthma that may include, but are not limited to, dyspnea, wheezing, chest tightness, cough, and/or sputum production.
•Must have documented SNP+ test result prior to Visit 2
•Have acceptable lung function at Visit 2 and Visit 4:
FEV1 =55% and =85% of the predicted value (or, =60% and =90% of the predicted value if subject is receiving controllers) at Visit 2, after withholding inhaled beta-agonist bronchodilators prior to spirometry (see section 5.5.1);
AND FEV1 =50% and =85% of the predicted value at Visit 4
•Have evidence of reversibility of airway obstruction, defined as an increase in FEV1 of at least 12% and at least 200mL when measured 10 to 30 minutes following short-acting beta-agonist (SABA)
•Have a history of asthma treatment, prior to Visit 1, that is in one of two categories (see section 4.2.1.3):
Controllers: Receiving stable doses of low- or medium-dose ICS, combination ICS/LABA, and/or other asthma controller medications; and (based on investigator’s judgment) can tolerate tapering of these controllers (e.g., ICS) or discontinuing these controllers (i.e., non-ICS) while receiving montelukast 10mg once daily (QD) starting at Visit 3; OR
Non-controllers: Not receiving asthma controller medications, and using only “as-needed” inhaled SABAs, for =4 weeks prior to Visit 1.
•Agree at Visit 3 to discontinue controllers (e.g., leukotriene antagonists other than montelukast), or taper them (e.g., ICS) over 2-4 weeks (as described in Appendix 12.10). Also, agree at Visit 3 to begin montelukast 10 mg QD.
•Have a daytime and nocturnal SABA administration average =1 puff per day, as recorded on the subject’s e-Diary for the last 7 days prior to Visit 4.
•Have an ACQ-6 score meeting the following requirements.
Non-controllers: At Visit 2, must have an ACQ-6 score =1.5 and a score between 1 and 6 for Question #6. At Visit 4, must have an ACQ-6 score =1.5.
Controllers: Visit 4 must have an ACQ-6 score =1.5.
•Not be pregnant

Refer to protocol for complete list

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
•Is unable to perform acceptable, repeatable spirometry.
•Has evidence of another clinically significant, active pulmonary disorder, such as bronchiectasis or COPD, documented by history, physical examination, or chest x-ray.
•Has been treated in an emergency room for asthma within 4 weeks of Visit 1 or has been hospitalized for asthma or respiratory condition within 2 months prior to Visit 1.
•Has had an upper respiratory tract infection (viral or bacterial) within 1 month prior to Visit 1.
•Has evidence of active, clinically significant sinus disease within 2 weeks prior to Visit 1.
•Experiences a clinically significant deterioration of asthma between Visit 2 and Visit 4. A significant deterioration of asthma is defined as one or more of the following:

Decrease in absolute FEV1 (in L) by 20% or more from the FEV1 at Visit 2;
Decrease in %-predicted FEV1 to less than 50% of the predicted value;
Clinical asthma exacerbation requiring emergency treatment, hospital admission (serious AE), or treatment with additional asthma medication (other than SABAs).

Refer to protocol for complete list



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Persistent asthma

Intervention(s)

Product Name: MK-1029
Product Code: MK-1029
Pharmaceutical Form: Tablet
INN or Proposed INN: MK-1029 Free Acid Form III
Current Sponsor code: MK-1029
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: MONTELUKAST
Product Code: MK-0476
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: MONTELUKAST SODIUM
Current Sponsor code: MK-0476
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: The end of Week 4 and Week 6 of treatment.

Secondary Objective: 1)Key Secondary Objective: To demonstrate that MK-1029, compared with placebo, improves control of asthma when added to montelukast.

2)Objective: To characterize the safety and tolerability of MK-1029, when added to montelukast, during 6 weeks of treatment.

Main Objective: To demonstrate that MK-1029, compared with placebo, increases lung function when added to montelukast.

Primary end point(s): Average change from baseline in FEV1 as measured at the end of Week 4 and Week 6 of treatment.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Percent of days with worsening asthma (%d-WA) as measured daily during Week 3 to Week 6 (inclusive) of treatment
-Timepoint of evaluation: measured daily during Week 3 to Week 6 (inclusive) of treatment
Percentage of subjects with adverse experience
-Timepoint of evaluation: during each period of the trial
Clinical and laboratory adverse experiences reported during the treatment period
-Timepoint of evaluation: during each period of the trial
Change from baseline in vital signs parameters and change or percent change (as appropriate) from baseline in laboratory safety parameters at the end of the trial
-Timepoint of evaluation: At the end of the treatment

Secondary end point(s): •Percent of days with worsening asthma (%d-WA) as measured daily during Week 3 to Week 6 (inclusive) of treatment

Safety Analysis
•Percentage of subjects with adverse experience
•Clinical and laboratory adverse experiences reported during the treatment period
•Change from baseline in vital signs parameters and change or percent change (as appropriate) from baseline in laboratory safety parameters at the end of the trial

Secondary ID(s)

MK-1029-015

Source(s) of Monetary Support

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.