AsthmaPhase 2NCT01624974
Study to Evaluate the Effectiveness and Safety of MK-1029 in the Treatment of Persistent Asthma That is Not Controlled With Montelukast (ML) in Adults (MK-1029-011)
A Phase 2 study testing MK-1029 and Montelukast (ML) in people with Asthma, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to evaluate the effect of MK-1029 on lung function in the treatment of adults who have persistent asthma that is uncontrolled with the use of montelukast (ML). Participants will use randomized study drug (either MK-1029 or placebo) for two separate 4-week treatment periods. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- MK-1029 and Montelukast (ML)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- No sites listed yet
- Study dates
- 9 Aug 2012to 5 May 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- not pregnant or breastfeeding and does not plan to become pregnant for the duration of the study;
- symptoms of persistent asthma for at least one year;
- current use of asthma treatments: 1) "as-needed" inhaled SABAs (albuterol/salbutamol) and no asthma controller for at least 4 weeks prior to Screening Visit OR 2) stable dose of ICS, combination ICS/LABA and/or oral asthma controller(s) for at least 4 weeks prior to Screening Visit and able to tolerate discontinuing all controllers while receiving ML;
- no history of smoking OR no smoking for at least 1 year, with a smoking history of no more than 10 pack-years;
- able to maintain a constant day/night, awake/sleep cycle;
- agrees to not change habitual consumption of beverages or foods containing caffeine throughout the study;
- Body Mass Index (BMI) of 15 kg/m^2 to 40 kg/m^2.
Who cannot join
- history of myocardial infarction, congestive heart failure, or uncontrolled cardiac arrhythmia within 3 months prior to Screening Visit;
- hospitalized or hospitalization within 4 weeks prior to Screening Visit;
- intention of moving or anticipation of missing any study visits;
- any major surgical procedure(s) within 4 weeks prior to Screening Visit;
- participation in a clinical trial involving an investigational drug within 4 weeks prior to Screening Visit;
- current regular use or a recent past abuse (within past 5 years) of alcohol (>14 drinks/week) or illicit drugs;
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- donation of a unit of blood within 2 weeks prior to Screening Visit or intention of donating a unit of blood during the study;
- evidence of another active pulmonary disorder such as bronchiectasis or COPD;
- treatment in an emergency room for asthma within 4 weeks prior to Screening Visit or hospitalization for asthma within 2 months prior to Screening Visit;
- respiratory tract infection which required treatment with antibiotics within 2 months prior to Screening Visit;
- evidence of active sinus disease within 1 week prior to Screening Visit;
- history of a psychiatric disorder, other than stable depression, within 3 months prior to Screening Visit;
- history of human immunodeficiency virus (HIV);
- hypersensitivity or intolerance to inhaled beta-agonists and/or leukotriene inhibitors or any of their ingredients, including lactose and galactose;
- unstable disease of the ophthalmologic, neurological, hepatic, renal, connective tissue, genitourinary, gastrointestinal, cardiovascular or hematologic systems;
- cancer (except for successfully treated basal and squamous cell carcinomas of the skin) or history of cancer within 5 years prior to Screening Visit;
- uncontrolled hypertension.
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Crossover Study of MK-1029 in Adult Subjects With Persistent Asthma Who Remain Uncontrolled While Being Maintained on Montelukast
The purpose of this study is to evaluate the effect of MK-1029 on lung function in the treatment of adults who have persistent asthma that is uncontrolled with the use of montelukast (ML). Participants will use randomized study drug (either MK-1029 or placebo) for two separate 4-week treatment periods. All participants will also use ML during the treatment periods. The primary hypothesis is that MK-1029 is superior to placebo in change from baseline in forced expiratory volume in one second (FEV1) at the end of the 4-week treatment period.
- Conditions
- Asthma
- Being tested
- MK-1029, Placebo, Montelukast (ML)
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-1029Drug
MK-1029 150 mg tablets taken QD
PlaceboDrug
Placebo tablets (matching the MK-1029 150 mg tablets) QD
Montelukast (ML)Drug
ML 10 mg tablets QD
| Study group | Role | What they receive |
|---|---|---|
| MK-1029/Placebo | Experimental | Participants received 4 weeks treatment with MK-1029 150 mg once daily (QD) + ML 10 mg QD in Period III and Placebo QD + ML 10 mg QD in Period V. Period IV was a 4-week wash-out period during which participants received single-blind Placebo QD and open-label ML 10 mg QD. Receives: Drug: MK-1029; Drug: Placebo; Drug: Montelukast (ML) |
| Placebo/MK-1029 | Experimental | Participants received 4 weeks treatment with Placebo QD + ML 10 mg QD in Period III and MK-1029 150 mg QD + ML 10 mg QD in Period V. Period IV was a 4-week wash-out period during which participants received single-blind Placebo QD and open-label ML 10 mg QD. Receives: Drug: MK-1029; Drug: Placebo; Drug: Montelukast (ML) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 4
The change from baseline in FEV1 at Week 4 following treatment with MK-1029 + ML or placebo + ML was assessed. The pre-bronchodilator FEV1 was evaluated to assess the response to treatment for asthma. The primary efficacy evaluation period was the last week of each treatment period: Period III (Initial Therapy, Week 4) and Period V (Crossover Therapy, Week 4). The change from baseline in FEV1 was evaluated using a longitudinal data analysis (LDA) model with repeated measurements of FEV1, with treatment, visit, treatment-by-visit interaction, and period as fixed effects, and participant as random effect. Baseline FEV1 is defined as the measurement taken before dosing in each treatment period (i. e., at Visit 3 [Week 0], prior to Period III and at Visit 6 [Week 8], prior to Period V). The Baseline Characteristics section shows FEV1 values at baseline.
Measured: The week before the first dose in Period III or V (Baseline) and the last week of Period III or V
Adverse Events During Treatment and Follow-up
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. The number of participants with at least one AE was assessed. The number of participants in any treatment group with at least one AE was assessed.
Measured: Up to 14 days after the last dose in Period III or Period V (up to 6 weeks)
Discontinuation of Treatment Due to An Adverse Event
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.
Measured: Up to the last dose in Period III or Period V (up to 4 weeks)
Secondary outcomes (6)
Change From Baseline in Daytime Symptom Score (DSS) at Week 4
The change from baseline in DSS at Week 4 following treatment was assessed. Participants used an electronic diary (e-Diary) to enter their asthma symptom scores every evening. Participants scored daily symptoms (chest discomfort, wheezing, shortness of breath, and cough) by responding to 4 questions: 1) Symptom frequency (0 = None of the time, 6 = All of the time); 2) Bothersomeness (0 = Not bothered, 6 = Severely bothered); 3) Activity limitation (0 = Not limited, 6 = Totally limited); 4) Frequency of activity limitation (0 = None of the time, 6 = All of the time). The average of the 4 scores for overall DSS ranges from 0 to 6 where a higher average indicates greater symptom severity. The average overall DSS was calculated over the week-long assessment periods. The change from baseline in DSS was evaluated using the LDA model with repeated measurements of DSS, with treatment, visit, treatment-by-visit interaction, and period as fixed effects, and participant as random effect.
Measured: The week before the first dose in Period III or V (Baseline) and the last week of Period III or V
Change From Baseline in Short-Acting Beta Agonist (SABA) Use at Week 4
The change from baseline in SABA use at Week 4 after treatment with MK-1029 + ML or placebo + ML was assessed. Participants used the e-Diary upon arising and before going to sleep to enter the total number of SABA puffs used for asthma relief. The number of SABA puffs recorded was the number of canister actuations (e. g., when SABA use was required and 3 puffs were inhaled, this was recorded as 3). Participants also recorded the number of nebulizer treatments (1 nebulized SABA use = 3 puffs). The average daily number of puffs for an individual participant was calculated over the week-long assessment periods. The change from baseline in SABA use was evaluated using the LDA model with repeated measurements of SABA use, with treatment, visit, treatment-by-visit interaction, and period as fixed effects, and participant as random effect.
Measured: The week before the first dose in Period III or V (Baseline) and the last week of Period III or V
Change From Baseline in Nocturnal Awakenings at Week 4
The change from baseline in nocturnal awakenings due to asthma at Week 4 after treatment with MK-1029 + ML or placebo + ML was assessed. The participant scored nocturnal awakenings by answering the question, "Did you wake up with asthma symptoms in the middle of the night or upon awakening in the morning?" (No or Yes). Participants recorded in the e-Diary the number of nights per week in which they awakened with asthma, as determined by dividing the number of nights of awakening with asthma by the total number of nights and then multiplying by 7 (standardized to a 7-day period). The change from baseline in nocturnal awakenings was evaluated using the LDA model with repeated measurements of nocturnal awakenings, with treatment, visit, treatment-by-visit interaction, and period as fixed effects, and participant as random effect.
Measured: The week before the first dose in Period III or V (Baseline) and the last week of Period III or V
Change From Baseline in Morning (AM) Peak Expiratory Flow (PEF) at Week 4
The change from baseline in AM PEF at Week 4 after treatment with MK-1029 + ML or placebo + ML was assessed in 97 participants. Participants performed triplicate AM PEF measurements in the morning upon rising. Participants entered all 3 measurements and the greatest AM PEF value was recorded by the e-Diary. Participants refrained from SABA use within the 4 hours prior to performing PEF measurements. The average AM PEF for an individual participant was calculated over the week-long assessment periods. The change from baseline in AM PEF was evaluated using the LDA model with repeated measurements of AM PEF, with treatment, visit, treatment-by-visit interaction, and period as fixed effects, and participant as random effect.
Measured: The week before the first dose in Period III or V (Baseline) and the last week of Period III or V
Change From Baseline in Evening (PM) PEF at Week 4
The change from baseline in PM PEF at Week 4 after treatment with MK-1029 + ML or placebo + ML was assessed. Participants performed triplicate PM PEF measurements in the evening, immediately before study drug administration, at bedtime. Participants entered all 3 measurements and the greatest PM PEF value was recorded by the e-Diary. Participants refrained from SABA use within the 4 hours prior to performing PEF measurements. The average PM PEF for an individual participant was calculated over the week-long assessment periods. The change from baseline in PM PEF was evaluated using the LDA model with repeated measurements of PM PEF, with treatment, visit, treatment-by-visit interaction, and period as fixed effects, and participant as random effect.
Measured: Baseline (Week 0 and Week 8), Last week of the 4-week treatment period
Change From Baseline in Asthma Control Questionnaire (ACQ) Score at Week 4
The change from baseline in the ACQ score at Week 4, after treatment, was assessed in 97 participants. Participants completed 6 items of the ACQ (i. e., ACQ-6) and provided the average of responses over the past week: 1) Frequency of nocturnal awakenings (0 = Never, 6 = Unable to sleep); 2) Symptom severity (0 = None, 6 = Very severe); 3) Activity limitations (0 = Not limited, 6 = Totally limited); 4) Breathlessness (0 = None, 6 = Very great deal); 5) Wheezing (0 = Not at all, 6 = All the time); 6) Daily SABA use (0 = None, 6 = More than 16 puffs on most days). The ACQ score ranges from 0 to 6 where a lower score indicates greater performance. The investigator reviewed the participant-completed ACQ-6 to ensure its completeness. The change from baseline in the ACQ score was evaluated using the LDA model with repeated measurements of the ACQ score, with treatment, visit, treatment-by-visit interaction, and period as fixed effects, and participant as random effect.
Measured: The week before the first dose in Period III or V (Baseline) and the last week of Period III or V
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2012 (estimated)
- Study start9 Aug 2012
- Primary completion5 May 2014
- Study completion5 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01624974
- Sponsor's protocol ID
- 1029-011
- Other IDs
- 2012-000642-35, MK-1029-011
- Status last verified
- Dec 2018
- First submitted
- 19 Jun 2012
- Last updated
- 2 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Crossover Study of MK-1029 in Adult Subjects With Persistent Asthma Who Remain Uncontrolled While Being Maintained on Montelukast
- ClinicalTrials.gov ID
- NCT01624974
- Acronym / sponsor ID
- 1029-011
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 9 Aug 2012 (actual)
- Primary completion
- 5 May 2014 (actual)
- Study completion
- 5 May 2014 (actual)
- First posted
- 21 Jun 2012 (estimated)
- Results
- Posted 23 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of MK-1029 on lung function in the treatment of adults who have persistent asthma that is uncontrolled with the use of montelukast (ML). Participants will use randomized study drug (either MK-1029 or placebo) for two separate 4-week treatment periods. All participants will also use ML during the treatment periods. The primary hypothesis is that MK-1029 is superior to placebo in change from baseline in forced expiratory volume in one second (FEV1) at the end of the 4-week treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MK-1029/Placebo | Experimental | Drug: MK-1029, Drug: Placebo, Drug: Montelukast (ML)Participants received 4 weeks treatment with MK-1029 150 mg once daily (QD) + ML 10 mg QD in Period III and Placebo QD + ML 10 mg QD in Period V. Period IV was a 4-week wash-out period during which participants received single-blind Placebo QD and open-label ML 10 mg QD. |
| Placebo/MK-1029 | Experimental | Drug: MK-1029, Drug: Placebo, Drug: Montelukast (ML)Participants received 4 weeks treatment with Placebo QD + ML 10 mg QD in Period III and MK-1029 150 mg QD + ML 10 mg QD in Period V. Period IV was a 4-week wash-out period during which participants received single-blind Placebo QD and open-label ML 10 mg QD. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- not pregnant or breastfeeding and does not plan to become pregnant for the duration of the study;
- symptoms of persistent asthma for at least one year;
- current use of asthma treatments: 1) "as-needed" inhaled SABAs (albuterol/salbutamol) and no asthma controller for at least 4 weeks prior to Screening Visit OR 2) stable dose of ICS, combination ICS/LABA and/or oral asthma controller(s) for at least 4 weeks prior to Screening Visit and able to tolerate discontinuing all controllers while receiving ML;
- no history of smoking OR no smoking for at least 1 year, with a smoking history of no more than 10 pack-years;
- able to maintain a constant day/night, awake/sleep cycle;
Key exclusion criteria (17 listed)
- history of myocardial infarction, congestive heart failure, or uncontrolled cardiac arrhythmia within 3 months prior to Screening Visit;
- hospitalized or hospitalization within 4 weeks prior to Screening Visit;
- intention of moving or anticipation of missing any study visits;
- any major surgical procedure(s) within 4 weeks prior to Screening Visit;
- participation in a clinical trial involving an investigational drug within 4 weeks prior to Screening Visit;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MK-1029MK-1029 150 mg tablets taken QD | Drug | MK-1029/Placebo, Placebo/MK-1029 |
| PlaceboPlacebo tablets (matching the MK-1029 150 mg tablets) QD | Drug | MK-1029/Placebo, Placebo/MK-1029 |
| Montelukast (ML)ML 10 mg tablets QD | Drug | MK-1029/Placebo, Placebo/MK-1029 |
Primary outcome
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 4
Time frame: The week before the first dose in Period III or V (Baseline) and the last week of Period III or V
The change from baseline in FEV1 at Week 4 following treatment with MK-1029 + ML or placebo + ML was assessed. The pre-bronchodilator FEV1 was evaluated to assess the response to treatment for asthma. The primary efficacy evaluation period was the last week of each treatment period: Period III (Initial Therapy, Week 4) and Period V (Crossover Therapy, Week 4). The change from baseline in FEV1 was evaluated using a longitudinal data analysis (LDA) model with repeated measurements of FEV1, with treatment, visit, treatment-by-visit interaction, and period as fixed effects, and participant as random effect. Baseline FEV1 is defined as the measurement taken before dosing in each treatment period (i. e., at Visit 3 [Week 0], prior to Period III and at Visit 6 [Week 8], prior to Period V). The Baseline Characteristics section shows FEV1 values at baseline.
Adverse Events During Treatment and Follow-up
Time frame: Up to 14 days after the last dose in Period III or Period V (up to 6 weeks)
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. The number of participants with at least one AE was assessed. The number of participants in any treatment group with at least one AE was assessed.
Discontinuation of Treatment Due to An Adverse Event
Time frame: Up to the last dose in Period III or Period V (up to 4 weeks)
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.
6 secondary outcomes
Change From Baseline in Daytime Symptom Score (DSS) at Week 4
Time frame: The week before the first dose in Period III or V (Baseline) and the last week of Period III or V
Change From Baseline in Short-Acting Beta Agonist (SABA) Use at Week 4
Time frame: The week before the first dose in Period III or V (Baseline) and the last week of Period III or V
Change From Baseline in Nocturnal Awakenings at Week 4
Time frame: The week before the first dose in Period III or V (Baseline) and the last week of Period III or V
Change From Baseline in Morning (AM) Peak Expiratory Flow (PEF) at Week 4
Time frame: The week before the first dose in Period III or V (Baseline) and the last week of Period III or V
Change From Baseline in Evening (PM) PEF at Week 4
Time frame: Baseline (Week 0 and Week 8), Last week of the 4-week treatment period
Change From Baseline in Asthma Control Questionnaire (ACQ) Score at Week 4
Time frame: The week before the first dose in Period III or V (Baseline) and the last week of Period III or V
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MK-1029 and Montelukast (ML) in people with Asthma, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 4 (time frame: The week before the first dose in Period III or V (Baseline) and the last week of Period III or V). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2019.