Trial Outcomes & Findings for Singulair(R) In Asthma And Allergic Rhinitis (0476-383) (NCT NCT00545844)
NCT ID: NCT00545844
Last Updated: 2024-05-23
Results Overview
Asthma control was assessed by the Canadian Asthma Consensus Guidelines at week 0 and week 8. Patients were considered uncontrolled if they answered "yes" to at least 2 of the 8 asthma control parameters.
COMPLETED
PHASE4
313 participants
8 weeks (from Week 0 to Week 8)
2024-05-23
Participant Flow
First 25 asthmatic patients seen consecutively at each site were invited to participate. Treatment phase: From the Survey population, blocks of 8 were allowed to participate. All subjects took 1 tablet of montelukast 10 mg once a day at bedtime. First patient in: APR-02-2007 Last patient out: JAN-25-2008
The anticipated Enrollment was 440, with an expected rate of 20% over the 8-week period, thus 369 patients should complete the study.
Participant milestones
| Measure |
All Patients
montelukast sodium, 10 mg, one tablet once a day for 8 weeks as add on therapy to usual current asthma controller treatment
Patients with comorbid allergic rhinitis and uncontrolled asthma were invited to participate in the treatment phase of the study. Of the 1004 patients who completed the survey phase, there were 319 eligible patients who advanced and participated in the treatment phase. Of the 319 eligible patients who advanced to the treatment phase 6 did not meet inclusion criteria leaving 313 patients.
|
|---|---|
|
Overall Study
STARTED
|
313
|
|
Overall Study
COMPLETED
|
301
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
All Patients
montelukast sodium, 10 mg, one tablet once a day for 8 weeks as add on therapy to usual current asthma controller treatment
Patients with comorbid allergic rhinitis and uncontrolled asthma were invited to participate in the treatment phase of the study. Of the 1004 patients who completed the survey phase, there were 319 eligible patients who advanced and participated in the treatment phase. Of the 319 eligible patients who advanced to the treatment phase 6 did not meet inclusion criteria leaving 313 patients.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Singulair(R) In Asthma And Allergic Rhinitis (0476-383)
Baseline characteristics by cohort
| Measure |
All Patients
n=313 Participants
montelukast sodium, 10 mg, one tablet once a day for 8 weeks as add on therapy to usual current asthma controller treatment
Patients with comorbid allergic rhinitis and uncontrolled asthma were invited to participate in the treatment phase of the study. Of the 1004 patients who completed the survey phase, there were 319 eligible patients who advanced and participated in the treatment phase. Of the 319 eligible patients who advanced to the treatment phase 6 did not meet inclusion criteria leaving 313 patients.
|
|---|---|
|
Age, Continuous
|
46.1 years
STANDARD_DEVIATION 17.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
199 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
114 Participants
n=5 Participants
|
|
Inhaled Corticosteroids or Inhaled Corticosteroids / Long-Acting Beta 2-Agonist Use
Inhaled Corticosteroids Only
|
154 participants
n=5 Participants
|
|
Inhaled Corticosteroids or Inhaled Corticosteroids / Long-Acting Beta 2-Agonist Use
Inhaled Corticosteroids/Long-Acting Beta 2-Agonist
|
153 participants
n=5 Participants
|
|
Inhaled Corticosteroids or Inhaled Corticosteroids / Long-Acting Beta 2-Agonist Use
Missing
|
6 participants
n=5 Participants
|
|
Allergic Rhinitis Diagnosis Duration
|
131.4 Months
STANDARD_DEVIATION 135.4 • n=5 Participants
|
|
Asthma Diagnosis Duration
|
147.6 Months
STANDARD_DEVIATION 139.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeks (from Week 0 to Week 8)Population: 319 patients advanced to the treatment phase and 313 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 301 patients who completed week 8.
Asthma control was assessed by the Canadian Asthma Consensus Guidelines at week 0 and week 8. Patients were considered uncontrolled if they answered "yes" to at least 2 of the 8 asthma control parameters.
Outcome measures
| Measure |
Treatment Phase (All Patients) Week 0
n=313 Participants
|
Treatment Phase (All Patients) Week 8
n=301 Participants
|
|---|---|---|
|
Asthma Control
Uncontrolled
|
312 Participants
|
72 Participants
|
|
Asthma Control
Controlled
|
0 Participants
|
229 Participants
|
|
Asthma Control
Missing
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 weeks (from Week 0 to Week 8)Population: Based on ITT population; there were 286 patients with available data regarding the mean change in MiniRQLQ at week 8.
Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) consists of 14 questions to assess patient's overall quality of life related to allergic rhinitis on a scale of 0 (least impairment) to 6 (greatest impairment). The score is the mean of the 14 questions, ranging from 0 to 6. Change is computed as Week 8 score - Week 0 score
Outcome measures
| Measure |
Treatment Phase (All Patients) Week 0
n=286 Participants
|
Treatment Phase (All Patients) Week 8
|
|---|---|---|
|
The Mean Change in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Score
|
-1.45 Units on a Scale
Standard Deviation 1.35
|
—
|
SECONDARY outcome
Timeframe: 8 weeks (from Week 0 to Week 8)Population: There were 313 patients who qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit; of these, 300 patients completed the ACQ at week 8.
The Asthma Control Questionnaire consists of 7 specific questions that were used to assess patient asthma control at week 0 and week 8. The mean score per question is used to determine the level of control, with a final score ranging from 0 (well-controlled) to 6 (extremely poorly controlled) units on a scale.
Outcome measures
| Measure |
Treatment Phase (All Patients) Week 0
n=313 Participants
|
Treatment Phase (All Patients) Week 8
n=300 Participants
|
|---|---|---|
|
Effectiveness of Montelukast Therapy Used in Combination With Inhaled Corticosteroids or Inhaled Corticosteroids / Long-Acting Beta 2-Agonist in Improving the Symptoms of Asthma Using the Asthma Control Questionnaire (ACQ)
|
2.03 Units on a Scale
Standard Deviation 0.80
|
0.92 Units on a Scale
Standard Deviation 0.80
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 weeks (from Week 0 to Week 8)Population: 319 patients advanced to the treatment phase and 313 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 301 patients who completed week 8.
At week 0 and week 8, patients were asked to complete a single question describing how satisfied they were regarding their asthma controller medication.
Outcome measures
| Measure |
Treatment Phase (All Patients) Week 0
n=313 Participants
|
Treatment Phase (All Patients) Week 8
n=301 Participants
|
|---|---|---|
|
Patient Global Satisfaction
Very satisfied
|
24 Participants
|
136 Participants
|
|
Patient Global Satisfaction
Satisfied
|
77 Participants
|
110 Participants
|
|
Patient Global Satisfaction
Neither satisfied or dissatisfied
|
104 Participants
|
36 Participants
|
|
Patient Global Satisfaction
Dissatisfied
|
97 Participants
|
16 Participants
|
|
Patient Global Satisfaction
Very dissatisfied
|
11 Participants
|
1 Participants
|
|
Patient Global Satisfaction
Missing
|
0 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 weeks (from Week 0 to Week 8)Population: 319 patients advanced to the treatment phase and 313 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 301 patients who completed week 8.
At week 0 and week 8, physicians were asked to complete a single question describing how satisfied they were regarding their patient's asthma controller medication.
Outcome measures
| Measure |
Treatment Phase (All Patients) Week 0
n=313 Participants
|
Treatment Phase (All Patients) Week 8
n=301 Participants
|
|---|---|---|
|
Physician Global Satisfaction
Very satisfied
|
7 Participants
|
135 Participants
|
|
Physician Global Satisfaction
Satisfied
|
54 Participants
|
110 Participants
|
|
Physician Global Satisfaction
Neither satisfied or dissatisfied
|
104 Participants
|
30 Participants
|
|
Physician Global Satisfaction
Dissatisfied
|
142 Participants
|
25 Participants
|
|
Physician Global Satisfaction
Very dissatisfied
|
4 Participants
|
1 Participants
|
|
Physician Global Satisfaction
Missing
|
2 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 weeks (from Week 0 to Week 8)Population: 319 patients advanced to the treatment phase and 313 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 301 patients who completed week 8.
At week 0 and week 8, patients were asked to complete one question describing their perception of their allergic rhinitis symptoms.
Outcome measures
| Measure |
Treatment Phase (All Patients) Week 0
n=313 Participants
|
Treatment Phase (All Patients) Week 8
n=301 Participants
|
|---|---|---|
|
Patient Global Allergic Rhinitis Symptoms Assessment
A non-issue as I do not have these symptoms
|
11 Participants
|
41 Participants
|
|
Patient Global Allergic Rhinitis Symptoms Assessment
Not really bothersome
|
35 Participants
|
129 Participants
|
|
Patient Global Allergic Rhinitis Symptoms Assessment
Bothersome a little of the time
|
73 Participants
|
77 Participants
|
|
Patient Global Allergic Rhinitis Symptoms Assessment
Bothersome some of the time
|
91 Participants
|
40 Participants
|
|
Patient Global Allergic Rhinitis Symptoms Assessment
Bothersome a good bit of the time
|
94 Participants
|
13 Participants
|
|
Patient Global Allergic Rhinitis Symptoms Assessment
Missing
|
9 Participants
|
1 Participants
|
Adverse Events
All Patients
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Patients
n=313 participants at risk
|
|---|---|
|
Immune system disorders
Allergic reaction Not Otherwise Specified
|
0.32%
1/313 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Asthma exacerbation
|
0.32%
1/313 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.32%
1/313 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.32%
1/313 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Asthma aggravated
|
0.32%
1/313 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
0.32%
1/313 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.32%
1/313 • Number of events 1
|
|
Gastrointestinal disorders
Swollen tongue
|
0.32%
1/313 • Number of events 1
|
|
Gastrointestinal disorders
Upset stomach
|
0.32%
1/313 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular pain
|
0.32%
1/313 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.32%
1/313 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
0.32%
1/313 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.32%
1/313 • Number of events 1
|
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