Trial Outcomes & Findings for Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246) (NCT NCT00974571)
NCT ID: NCT00974571
Last Updated: 2022-02-03
Results Overview
Mean change from baseline in Daytime Nasal Symptoms score. Patients were asked to rate each nasal symptom of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale \[Score 0 (best) to 3 (worst)\]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1365 participants
Primary outcome timeframe
Baseline and first 4 weeks of a 6-week treatment period
Results posted on
2022-02-03
Participant Flow
74 study sites in the United States Primary Therapy: Nov-2001 to May-2002
Patients who required excluded medication and those who did not meet a minimum predefined level of combined daytime rhinitis symptoms score during the run-in period were excluded from randomization.
Participant milestones
| Measure |
Montelukast 10 mg
Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
|
Cetirizine 10 mg
Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
|
Placebo
Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
630
|
122
|
613
|
|
Overall Study
COMPLETED
|
562
|
106
|
530
|
|
Overall Study
NOT COMPLETED
|
68
|
16
|
83
|
Reasons for withdrawal
| Measure |
Montelukast 10 mg
Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
|
Cetirizine 10 mg
Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
|
Placebo
Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
31
|
4
|
27
|
|
Overall Study
Lack of Efficacy
|
3
|
2
|
9
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
2
|
|
Overall Study
Protocol Violation
|
13
|
4
|
18
|
|
Overall Study
Withdrawal by Subject
|
14
|
5
|
16
|
|
Overall Study
Patient Moved
|
1
|
0
|
1
|
|
Overall Study
Other
|
4
|
0
|
10
|
Baseline Characteristics
Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246)
Baseline characteristics by cohort
| Measure |
Montelukast 10 mg
n=630 Participants
Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
|
Cetirizine 10 mg
n=122 Participants
Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
|
Placebo
n=613 Participants
Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
|
Total
n=1365 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
35.3 years
STANDARD_DEVIATION 12.87 • n=5 Participants
|
36.3 years
STANDARD_DEVIATION 13.67 • n=7 Participants
|
35.3 years
STANDARD_DEVIATION 13.17 • n=5 Participants
|
35.4 years
STANDARD_DEVIATION 13.07 • n=4 Participants
|
|
Sex: Female, Male
Female
|
419 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
418 Participants
n=5 Participants
|
922 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
211 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
443 Participants
n=4 Participants
|
|
Composite Symptoms score
|
1.86 Scores on a scale
STANDARD_DEVIATION 0.44 • n=5 Participants
|
1.89 Scores on a scale
STANDARD_DEVIATION 0.43 • n=7 Participants
|
1.82 Scores on a scale
STANDARD_DEVIATION 0.45 • n=5 Participants
|
1.85 Scores on a scale
STANDARD_DEVIATION 0.44 • n=4 Participants
|
|
Daytime Nasal Symptoms score
|
2.08 Scores on a scale
STANDARD_DEVIATION 0.40 • n=5 Participants
|
2.13 Scores on a scale
STANDARD_DEVIATION 0.37 • n=7 Participants
|
2.07 Scores on a scale
STANDARD_DEVIATION 0.40 • n=5 Participants
|
2.08 Scores on a scale
STANDARD_DEVIATION 0.40 • n=4 Participants
|
|
Nighttime Symptoms score
|
1.63 Scores on a scale
STANDARD_DEVIATION 0.62 • n=5 Participants
|
1.65 Scores on a scale
STANDARD_DEVIATION 0.61 • n=7 Participants
|
1.58 Scores on a scale
STANDARD_DEVIATION 0.62 • n=5 Participants
|
1.61 Scores on a scale
STANDARD_DEVIATION 0.62 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and first 4 weeks of a 6-week treatment periodPopulation: All patients who had a baseline and at least one posttreatment measurement were included.
Mean change from baseline in Daytime Nasal Symptoms score. Patients were asked to rate each nasal symptom of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale \[Score 0 (best) to 3 (worst)\]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score.
Outcome measures
| Measure |
Montelukast 10 mg
n=626 Participants
Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
|
Cetirizine 10 mg
n=120 Participants
Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
|
Placebo
n=609 Participants
Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
|
|---|---|---|---|
|
Mean Change From Baseline in Daytime Nasal Symptoms Score
|
-0.39 Scores on a scale
Interval -0.43 to -0.36
|
-0.45 Scores on a scale
Interval -0.54 to -0.37
|
-0.36 Scores on a scale
Interval -0.39 to -0.32
|
SECONDARY outcome
Timeframe: Baseline and first 4 weeks in 6-week treatment periodPopulation: All patients who had a baseline and at least one posttreatment measurement were included.
Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptom daily on a 4-point scale \[Score 0 (best) to 3 (worst)\], and the average score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score.
Outcome measures
| Measure |
Montelukast 10 mg
n=626 Participants
Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
|
Cetirizine 10 mg
n=120 Participants
Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
|
Placebo
n=609 Participants
Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
|
|---|---|---|---|
|
Mean Change From Baseline in Nighttime Symptoms Score
|
-0.28 Scores on a scale
Interval -0.32 to -0.25
|
-0.30 Scores on a scale
Interval -0.38 to -0.23
|
-0.26 Scores on a scale
Interval -0.29 to -0.22
|
SECONDARY outcome
Timeframe: Baseline and first 4 weeks in 6-week treatment periodPopulation: All patients who had a baseline and at least one posttreatment measurement were included.
Composite Symptoms Scores were computed as the average of the Daytime Nasal Symptoms Scores \[Score 0 (best) to 3 (worst)\]. and Nighttime Symptoms Scores collected \[Score 0 (best) to 3 (worst)\].
Outcome measures
| Measure |
Montelukast 10 mg
n=626 Participants
Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
|
Cetirizine 10 mg
n=120 Participants
Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
|
Placebo
n=609 Participants
Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
|
|---|---|---|---|
|
Mean Change From Baseline in Composite Symptoms Score
|
-0.34 Score 0 (best) to 3 (worst)
Interval -0.37 to -0.31
|
-0.38 Score 0 (best) to 3 (worst)
Interval -0.45 to -0.31
|
-0.30 Score 0 (best) to 3 (worst)
Interval -0.34 to -0.27
|
SECONDARY outcome
Timeframe: End of the first 4 weeks in 6-week treatment periodPopulation: The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.
An evaluation by the patient, administered at week 4 of the study (or upon discontinuation) using a 7-point scale \[Score 0 (best) to 6 (worst)\], of the change in symptoms as compared to the beginning of the study.
Outcome measures
| Measure |
Montelukast 10 mg
n=617 Participants
Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
|
Cetirizine 10 mg
n=117 Participants
Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
|
Placebo
n=602 Participants
Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
|
|---|---|---|---|
|
Patient's Global Evaluation of Allergic Rhinitis
|
2.22 Scores on a scale
Interval 2.11 to 2.32
|
2.15 Scores on a scale
Interval 1.92 to 2.38
|
2.41 Scores on a scale
Interval 2.3 to 2.51
|
SECONDARY outcome
Timeframe: End of the first 4 weeks in 6-week treatment periodPopulation: The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.
An evaluation by the physician, administered at week 4 of the study (or upon discontinuation) using a 7-point scale \[Score 0 (best) to 6 (worst)\], of the change in symptoms as compared to the beginning of the study.
Outcome measures
| Measure |
Montelukast 10 mg
n=603 Participants
Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
|
Cetirizine 10 mg
n=115 Participants
Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
|
Placebo
n=583 Participants
Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
|
|---|---|---|---|
|
Physician's Global Evaluation of Allergic Rhinitis
|
2.26 Scores on a scale
Interval 2.16 to 2.36
|
2.20 Scores on a scale
Interval 1.99 to 2.42
|
2.33 Scores on a scale
Interval 2.23 to 2.43
|
Adverse Events
Montelukast 10 mg
Serious events: 2 serious events
Other events: 85 other events
Deaths: 0 deaths
Cetirizine 10 mg
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 65 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Montelukast 10 mg
n=630 participants at risk
Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
|
Cetirizine 10 mg
n=122 participants at risk
Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
|
Placebo
n=613 participants at risk
Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Laceration
|
0.16%
1/630 • During the 6 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of patients listed in the Adverse Event tables (613 in the placebo group, 630 in the montelukast group, and 122 in the cetirizine group) is the number of patients who received study treatment.
|
0.00%
0/122 • During the 6 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of patients listed in the Adverse Event tables (613 in the placebo group, 630 in the montelukast group, and 122 in the cetirizine group) is the number of patients who received study treatment.
|
0.00%
0/613 • During the 6 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of patients listed in the Adverse Event tables (613 in the placebo group, 630 in the montelukast group, and 122 in the cetirizine group) is the number of patients who received study treatment.
|
|
Cardiac disorders
Unstable Angina
|
0.00%
0/630 • During the 6 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of patients listed in the Adverse Event tables (613 in the placebo group, 630 in the montelukast group, and 122 in the cetirizine group) is the number of patients who received study treatment.
|
0.00%
0/122 • During the 6 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of patients listed in the Adverse Event tables (613 in the placebo group, 630 in the montelukast group, and 122 in the cetirizine group) is the number of patients who received study treatment.
|
0.16%
1/613 • During the 6 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of patients listed in the Adverse Event tables (613 in the placebo group, 630 in the montelukast group, and 122 in the cetirizine group) is the number of patients who received study treatment.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.16%
1/630 • During the 6 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of patients listed in the Adverse Event tables (613 in the placebo group, 630 in the montelukast group, and 122 in the cetirizine group) is the number of patients who received study treatment.
|
0.00%
0/122 • During the 6 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of patients listed in the Adverse Event tables (613 in the placebo group, 630 in the montelukast group, and 122 in the cetirizine group) is the number of patients who received study treatment.
|
0.33%
2/613 • During the 6 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of patients listed in the Adverse Event tables (613 in the placebo group, 630 in the montelukast group, and 122 in the cetirizine group) is the number of patients who received study treatment.
|
Other adverse events
| Measure |
Montelukast 10 mg
n=630 participants at risk
Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
|
Cetirizine 10 mg
n=122 participants at risk
Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
|
Placebo
n=613 participants at risk
Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
|
|---|---|---|---|
|
Infections and infestations
Upper Respiratory Infection
|
6.5%
41/630 • During the 6 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of patients listed in the Adverse Event tables (613 in the placebo group, 630 in the montelukast group, and 122 in the cetirizine group) is the number of patients who received study treatment.
|
6.6%
8/122 • During the 6 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of patients listed in the Adverse Event tables (613 in the placebo group, 630 in the montelukast group, and 122 in the cetirizine group) is the number of patients who received study treatment.
|
5.5%
34/613 • During the 6 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of patients listed in the Adverse Event tables (613 in the placebo group, 630 in the montelukast group, and 122 in the cetirizine group) is the number of patients who received study treatment.
|
|
Nervous system disorders
Headache
|
7.5%
47/630 • During the 6 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of patients listed in the Adverse Event tables (613 in the placebo group, 630 in the montelukast group, and 122 in the cetirizine group) is the number of patients who received study treatment.
|
6.6%
8/122 • During the 6 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of patients listed in the Adverse Event tables (613 in the placebo group, 630 in the montelukast group, and 122 in the cetirizine group) is the number of patients who received study treatment.
|
5.9%
36/613 • During the 6 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of patients listed in the Adverse Event tables (613 in the placebo group, 630 in the montelukast group, and 122 in the cetirizine group) is the number of patients who received study treatment.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
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