Trial Outcomes & Findings for Pediatric ACTION3 (Identify, Treat, Control): Effectiveness of Adding Montelukast in Pediatric Subjects With Uncontrolled Asthma (0476-385) (NCT NCT00832455)
NCT ID: NCT00832455
Last Updated: 2024-05-13
Results Overview
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.
COMPLETED
PHASE4
445 participants
Week 0, 4, and 12
2024-05-13
Participant Flow
First patient in: JUN-19-2006 Last patient out: OCT-28-2008 Total number of sites: 37 sites in Canada
Participant milestones
| Measure |
Montelukast
Montelukast 4-5 mg for 12 weeks, oral tablet
|
|---|---|
|
Overall Study
STARTED
|
445
|
|
Overall Study
Baseline
|
420
|
|
Overall Study
Week 4
|
411
|
|
Overall Study
Week 8 (Optional)
|
247
|
|
Overall Study
Week 12
|
373
|
|
Overall Study
COMPLETED
|
373
|
|
Overall Study
NOT COMPLETED
|
72
|
Reasons for withdrawal
| Measure |
Montelukast
Montelukast 4-5 mg for 12 weeks, oral tablet
|
|---|---|
|
Overall Study
Adverse Event
|
13
|
|
Overall Study
Lost to Follow-up
|
26
|
|
Overall Study
Protocol Violation
|
4
|
|
Overall Study
Withdrawal by Subject
|
17
|
|
Overall Study
Screening Failure
|
2
|
|
Overall Study
Stopped Medication
|
4
|
|
Overall Study
Parent misunderstood study
|
1
|
|
Overall Study
Parent dissatisfied
|
1
|
|
Overall Study
No improvement
|
3
|
|
Overall Study
Patient moved
|
1
|
Baseline Characteristics
Pediatric ACTION3 (Identify, Treat, Control): Effectiveness of Adding Montelukast in Pediatric Subjects With Uncontrolled Asthma (0476-385)
Baseline characteristics by cohort
| Measure |
Montelukast
n=420 Participants
Montelukast 4-5 mg for 12 weeks, oral tablet
|
|---|---|
|
Age, Continuous
|
7.00 years
STANDARD_DEVIATION 3.33 • n=5 Participants
|
|
Sex: Female, Male
Female
|
168 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
252 Participants
n=5 Participants
|
|
ICS (Inhaled Corticosteroids) Use
Use
|
323 Participants
n=5 Participants
|
|
ICS (Inhaled Corticosteroids) Use
No Use
|
97 Participants
n=5 Participants
|
|
Asthma Diagnosis Duration
|
45.58 Months
STANDARD_DEVIATION 34.72 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0, 4, and 12Population: 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.
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.
Outcome measures
| Measure |
Montelukast ITT at Week 0
n=420 Participants
ITT population, receiving montelukast 4 or 5 mg/day
|
Montelukast ITT at Week 4
n=411 Participants
ITT population, receiving montelukast 4 or 5 mg/day
|
Montelukast ITT at Week 12
n=373 Participants
ITT population, receiving montelukast 4 or 5 mg/day
|
Montelukast ITT at Week 12
|
|---|---|---|---|---|
|
Asthma Control Questionnaire (ACQ)
Not well controlled
|
328 Participants
|
159 Participants
|
96 Participants
|
—
|
|
Asthma Control Questionnaire (ACQ)
Well controlled
|
91 Participants
|
251 Participants
|
276 Participants
|
—
|
|
Asthma Control Questionnaire (ACQ)
Missing
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 0, 4, and 12Population: 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.
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.
Outcome measures
| Measure |
Montelukast ITT at Week 0
n=420 Participants
ITT population, receiving montelukast 4 or 5 mg/day
|
Montelukast ITT at Week 4
n=411 Participants
ITT population, receiving montelukast 4 or 5 mg/day
|
Montelukast ITT at Week 12
n=373 Participants
ITT population, receiving montelukast 4 or 5 mg/day
|
Montelukast ITT at Week 12
|
|---|---|---|---|---|
|
Asthma Control Questionnaire (ACQ)
Not tapered and Not well controlled
|
144 Participants
|
60 Participants
|
82 Participants
|
—
|
|
Asthma Control Questionnaire (ACQ)
Not tapered and Well controlled
|
208 Participants
|
121 Participants
|
216 Participants
|
—
|
|
Asthma Control Questionnaire (ACQ)
Tapered and Not well controlled
|
15 Participants
|
14 Participants
|
14 Participants
|
—
|
|
Asthma Control Questionnaire (ACQ)
Tapered and Well controlled
|
43 Participants
|
52 Participants
|
60 Participants
|
—
|
|
Asthma Control Questionnaire (ACQ)
Missing
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: week 0, 4, 8 and 12Population: 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.
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.
Outcome measures
| Measure |
Montelukast ITT at Week 0
n=420 Participants
ITT population, receiving montelukast 4 or 5 mg/day
|
Montelukast ITT at Week 4
n=411 Participants
ITT population, receiving montelukast 4 or 5 mg/day
|
Montelukast ITT at Week 12
n=247 Participants
ITT population, receiving montelukast 4 or 5 mg/day
|
Montelukast ITT at Week 12
n=373 Participants
|
|---|---|---|---|---|
|
Physician Global Satisfaction
Very satisfied
|
2 Participants
|
130 Participants
|
116 Participants
|
186 Participants
|
|
Physician Global Satisfaction
Satisfied
|
23 Participants
|
148 Participants
|
100 Participants
|
136 Participants
|
|
Physician Global Satisfaction
Neither Satisfied or Dissatisfied
|
96 Participants
|
101 Participants
|
22 Participants
|
32 Participants
|
|
Physician Global Satisfaction
Dissatisfied
|
266 Participants
|
28 Participants
|
7 Participants
|
14 Participants
|
|
Physician Global Satisfaction
Very Dissatisfied
|
26 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Physician Global Satisfaction
Missing
|
7 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 0, 4, 8 and 12Population: 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.
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.
Outcome measures
| Measure |
Montelukast ITT at Week 0
n=420 Participants
ITT population, receiving montelukast 4 or 5 mg/day
|
Montelukast ITT at Week 4
n=411 Participants
ITT population, receiving montelukast 4 or 5 mg/day
|
Montelukast ITT at Week 12
n=247 Participants
ITT population, receiving montelukast 4 or 5 mg/day
|
Montelukast ITT at Week 12
n=373 Participants
|
|---|---|---|---|---|
|
Patient Global Satisfaction
Very Satisfied
|
11 Participants
|
145 Participants
|
129 Participants
|
194 Participants
|
|
Patient Global Satisfaction
Satisfied
|
62 Participants
|
161 Participants
|
87 Participants
|
120 Participants
|
|
Patient Global Satisfaction
Neither Satisfied or Dissatisfied
|
137 Participants
|
74 Participants
|
24 Participants
|
48 Participants
|
|
Patient Global Satisfaction
Dissatisfied
|
190 Participants
|
26 Participants
|
6 Participants
|
7 Participants
|
|
Patient Global Satisfaction
Very Dissatisfied
|
18 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
|
Patient Global Satisfaction
Missing
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Weeks 4, 8, and 12Population: 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.
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.
Outcome measures
| Measure |
Montelukast ITT at Week 0
n=411 Participants
ITT population, receiving montelukast 4 or 5 mg/day
|
Montelukast ITT at Week 4
n=247 Participants
ITT population, receiving montelukast 4 or 5 mg/day
|
Montelukast ITT at Week 12
n=373 Participants
ITT population, receiving montelukast 4 or 5 mg/day
|
Montelukast ITT at Week 12
|
|---|---|---|---|---|
|
Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)
|
1.06 Units on a Scale
Standard Deviation 1.27
|
1.39 Units on a Scale
Standard Deviation 1.39
|
1.36 Units on a Scale
Standard Deviation 1.34
|
—
|
Adverse Events
Montelukast
Serious adverse events
| Measure |
Montelukast
Montelukast 4-5 mg for 12 weeks, oral tablet
|
|---|---|
|
Infections and infestations
Bronchitis
|
0.22%
1/445 • Number of events 1
|
|
Infections and infestations
Pneumomia
|
0.22%
1/445 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.45%
2/445 • Number of events 2
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.22%
1/445 • Number of events 1
|
Other adverse events
| Measure |
Montelukast
Montelukast 4-5 mg for 12 weeks, oral tablet
|
|---|---|
|
General disorders
Pyrexia
|
2.2%
10/445 • Number of events 10
|
|
Infections and infestations
Lower respiratory tract infection
|
0.90%
4/445 • Number of events 4
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
30/445 • Number of events 31
|
|
Infections and infestations
Otitis media
|
1.8%
8/445 • Number of events 8
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.90%
4/445 • Number of events 4
|
|
Infections and infestations
Pneumonia
|
1.1%
5/445 • Number of events 5
|
|
Infections and infestations
Upper respiratory tract infection
|
7.4%
33/445 • Number of events 33
|
|
Infections and infestations
Viral infection
|
3.4%
15/445 • Number of events 15
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.90%
4/445 • Number of events 4
|
|
Nervous system disorders
Headache
|
1.1%
5/445 • Number of events 5
|
|
Psychiatric disorders
Nightmare
|
1.3%
6/445 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.8%
26/445 • Number of events 26
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.8%
8/445 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.90%
4/445 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.90%
4/445 • Number of events 4
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER