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Pediatric ACTION3 (Identify, Treat, Control): Effectiveness of Adding Montelukast in Pediatric Subjects With Uncontrolled Asthma (0476-385)

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ClinicalTrials.gov Identifier: NCT00832455
Recruitment Status : Completed
First Posted : January 30, 2009
Results First Posted : February 5, 2010
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Asthma
Intervention Drug: montelukast sodium
Enrollment 445
Recruitment Details

First patient in: JUN-19-2006

Last patient out: OCT-28-2008

Total number of sites: 37 sites in Canada

Pre-assignment Details  
Arm/Group Title Montelukast
Hide Arm/Group Description Montelukast 4-5 mg for 12 weeks, oral tablet
Period Title: Overall Study
Started 445 [1]
Baseline 420 [2]
Week 4 411
Week 8 (Optional) 247
Week 12 373
Completed 373
Not Completed 72
Reason Not Completed
Adverse Event             13
Lost to Follow-up             26
Protocol Violation             4
Withdrawal by Subject             17
Screening Failure             2
Stopped Medication             4
Parent misunderstood study             1
Parent dissatisfied             1
No improvement             3
Patient moved             1
[1]
445 – number of patients that signed the informed consent form (Safety population)
[2]
420 –patients that received at least one dose of study medication and had 1 follow-up visit (ITT)
Arm/Group Title Montelukast
Hide Arm/Group Description Montelukast 4-5 mg for 12 weeks, oral tablet
Overall Number of Baseline Participants 420
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 420 participants
7.00  (3.33)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 420 participants
Female
168
  40.0%
Male
252
  60.0%
ICS (Inhaled Corticosteroids) Use  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 420 participants
Use 323
No Use 97
Asthma Diagnosis Duration  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 420 participants
45.58  (34.72)
1.Primary Outcome
Title Asthma Control Questionnaire (ACQ)
Hide Description ACQ is a questionnaire consisting of seven 7-point Likert scale questions describing frequency and severity of asthma symptoms. Score ranges between 0 (well-controlled) and 6 (extremely poorly controlled); a score of ≤0.75 indicates well controlled symptoms.
Time Frame Week 0, 4, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
420 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 411 patients who completed week 4 and the 373 patients who completed week 12.
Arm/Group Title Montelukast ITT at Week 0 Montelukast ITT at Week 4 Montelukast ITT at Week 12
Hide Arm/Group Description:
ITT population, receiving montelukast 4 or 5 mg/day
ITT population, receiving montelukast 4 or 5 mg/day
ITT population, receiving montelukast 4 or 5 mg/day
Overall Number of Participants Analyzed 420 411 373
Measure Type: Number
Unit of Measure: Participants
Not well controlled 328 159 96
Well controlled 91 251 276
Missing 1 1 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Montelukast ITT at Week 0, Montelukast ITT at Week 12
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Montelukast ITT at Week 0, Montelukast ITT at Week 4
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
2.Secondary Outcome
Title Asthma Control Questionnaire (ACQ)
Hide Description ACQ is a questionnaire consisting of seven 7-point Likert scale questions describing frequency and severity of asthma symptoms. Score ranges between 0 (well-controlled) and 6 (extremely poorly controlled); a score of ≤0.75 indicates well controlled symptoms.
Time Frame Week 0, 4, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
420 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 411 patients who completed week 4, the 247 who completed week 8, and the 373 patients who completed week 12.
Arm/Group Title Montelukast ITT at Week 0 Montelukast ITT at Week 4 Montelukast ITT at Week 12
Hide Arm/Group Description:
ITT population, receiving montelukast 4 or 5 mg/day
ITT population, receiving montelukast 4 or 5 mg/day
ITT population, receiving montelukast 4 or 5 mg/day
Overall Number of Participants Analyzed 420 411 373
Measure Type: Number
Unit of Measure: Participants
Not tapered and Not well controlled 144 60 82
Not tapered and Well controlled 208 121 216
Tapered and Not well controlled 15 14 14
Tapered and Well controlled 43 52 60
Missing 1 0 1
3.Other Pre-specified Outcome
Title Physician Global Satisfaction
Hide Description At week 0, 4, 8 and 12, physicians were asked to complete a single question describing how satisfied they were regarding the asthma controller medication for each of their enrolled patients.
Time Frame week 0, 4, 8 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
420 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 411 patients who completed week 4, the 247 who completed week 8, and the 373 patients who completed week 12.
Arm/Group Title Montelukast ITT at Week 0 Montelukast ITT at Week 4 Montelukast ITT at Week 8 Montelukast ITT at Week 12
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 420 411 247 373
Measure Type: Number
Unit of Measure: Participants
Very satisfied 2 130 116 186
Satisfied 23 148 100 136
Neither Satisfied or Dissatisfied 96 101 22 32
Dissatisfied 266 28 7 14
Very Dissatisfied 26 1 0 3
Missing 7 3 2 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Montelukast ITT at Week 0, Montelukast ITT at Week 12
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method McNemar-Bowker
Comments The McNemar-Bowker test is a statistical procedure used to compare the proportion of physician satisfaction at week 0 compared to week 12.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Montelukast ITT at Week 0, Montelukast ITT at Week 8
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method McNemar-Bowker
Comments The McNemar-Bowker test is a statistical procedure used to compare the proportion of physician satisfaction at week 0 compared to week 8.
4.Other Pre-specified Outcome
Title Patient Global Satisfaction
Hide Description At week 0, 4, 8 and 12, patients were asked to complete a single question describing how satisfied they were regarding their asthma controller medication.
Time Frame Week 0, 4, 8 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
420 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 411 patients who completed week 4, the 247 who completed week 8, and the 373 patients who completed week 12.
Arm/Group Title Montelukast ITT at Week 0 Montelukast ITT at Week 4 Montelukast ITT at Week 8 Montelukast ITT at Week 12
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 420 411 247 373
Measure Type: Number
Unit of Measure: Participants
Very Satisfied 11 145 129 194
Satisfied 62 161 87 120
Neither Satisfied or Dissatisfied 137 74 24 48
Dissatisfied 190 26 6 7
Very Dissatisfied 18 3 0 2
Missing 2 2 1 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Montelukast ITT at Week 0, Montelukast ITT at Week 12
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method McNemar-Bowker
Comments The McNemar-Bowker test is a statistical procedure used to compare the proportion of patient satisfaction at week 0 compared to week 12.
5.Other Pre-specified Outcome
Title Pediatric Asthma Caregiver’s Quality of Life Questionnaire (PACQLQ)
Hide Description

The change in the quality of life of the caregivers of patients treated with montelukast for the control of asthma used in combination with inhaled corticosteroids, using the Pediatric Asthma Caregiver’s Quality of Life Questionnaire (PACQLQ).

PACQLQ score ranges between 1 (severe impairment) and 7 (no impairment) where a higher score indicates better quality of life. An average change in overall score ≥0.7 is considered clinically significant. Changes between visits and baseline are described.

Time Frame Weeks 4, 8, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
420 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 411 patients who completed week 4, the 247 who completed week 8, and the 373 patients who completed week 12.
Arm/Group Title Montelukast ITT at Week 4 Montelukast ITT at Week 8 Montelukast ITT at Week 12
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 411 247 373
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
1.06  (1.27) 1.39  (1.39) 1.36  (1.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Montelukast ITT at Week 12
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments Change in PACQLQ score between Week 12 and baseline is statistically different than zero
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Montelukast
Hide Arm/Group Description Montelukast 4-5 mg for 12 weeks, oral tablet
All-Cause Mortality
Montelukast
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Montelukast
Affected / at Risk (%) # Events
Total   5    
Infections and infestations   
Bronchitis  1  1/445 (0.22%)  1
Pneumomia  1  1/445 (0.22%)  1
Injury, poisoning and procedural complications   
Accidental overdose  1  1/445 (0.22%)  1
Respiratory, thoracic and mediastinal disorders   
Asthma  1  2/445 (0.45%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Montelukast
Affected / at Risk (%) # Events
Total   146    
General disorders   
Pyrexia  1  10/445 (2.25%)  10
Infections and infestations   
Lower respiratory tract infection  1  4/445 (0.90%)  4
Nasopharyngitis  1  30/445 (6.74%)  31
Otitis media  1  8/445 (1.80%)  8
Pharyngitis streptococcal  1  4/445 (0.90%)  4
Pneumonia  1  5/445 (1.12%)  5
Upper respiratory tract infection  1  33/445 (7.42%)  33
Viral infection  1  15/445 (3.37%)  15
Viral upper respiratory tract infection  1  4/445 (0.90%)  4
Nervous system disorders   
Headache  1  5/445 (1.12%)  5
Psychiatric disorders   
Nightmare  1  6/445 (1.35%)  6
Respiratory, thoracic and mediastinal disorders   
Asthma  1  26/445 (5.84%)  26
Cough  1  8/445 (1.80%)  8
Wheezing  1  4/445 (0.90%)  4
Skin and subcutaneous tissue disorders   
Rash  1  4/445 (0.90%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00832455     History of Changes
Other Study ID Numbers: 0476-385
MK0476-385
2009_523
First Submitted: January 28, 2009
First Posted: January 30, 2009
Results First Submitted: August 25, 2009
Results First Posted: February 5, 2010
Last Update Posted: April 10, 2017