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Phase 2 Completed N=107 Randomized Double-blind Treatment

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)

Source: ClinicalTrials.gov NCT01624974 ↗
Enrolled (actual)
107
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcomePrimary: Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 4 — 0.065; 0.017 Liters — p=0.282

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. 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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 4
0.065; 0.017 0.282
PRIMARY
Adverse Events During Treatment and Follow-up
30; 33
PRIMARY
Discontinuation of Treatment Due to An Adverse Event
2; 2
SECONDARY
Change From Baseline in Daytime Symptom Score (DSS) at Week 4
1.93; 1.98; -0.18; -0.08
SECONDARY
Change From Baseline in Short-Acting Beta Agonist (SABA) Use at Week 4
3.203; 3.597; -0.595; -0.561
SECONDARY
Change From Baseline in Nocturnal Awakenings at Week 4
4.97; 4.90; -1.13; -1.30
SECONDARY
Change From Baseline in Morning (AM) Peak Expiratory Flow (PEF) at Week 4
336.57; 333.07; 7.14; -2.70
SECONDARY
Change From Baseline in Evening (PM) PEF at Week 4
350.34; 342.30; 8.25; -4.68
SECONDARY
Change From Baseline in Asthma Control Questionnaire (ACQ) Score at Week 4
2.09; 2.25; -0.49; -0.48

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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;
  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01624974). 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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