Trial Outcomes & Findings for Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117) (NCT NCT00963599)
NCT ID: NCT00963599
Last Updated: 2022-02-09
Results Overview
Mean change from baseline in Daytime Nasal Symptoms score. Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale (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
907 participants
Primary outcome timeframe
Baseline and Week 2
Results posted on
2022-02-09
Participant Flow
Forty study centers in the United States. Therapy Period: September 1999 to November 1999
Patients who required excluded medication and those who did not meet a minimum predefined level of combined Daytime Nasal Symptoms score during the run-in period were excluded from randomization.
Participant milestones
| Measure |
Placebo
Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Montelukast
Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Loratadine
Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Montelukast/Loratadine
Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
149
|
155
|
301
|
302
|
|
Overall Study
COMPLETED
|
143
|
149
|
292
|
288
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
9
|
14
|
Reasons for withdrawal
| Measure |
Placebo
Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Montelukast
Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Loratadine
Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Montelukast/Loratadine
Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
1
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
1
|
|
Overall Study
Protocol Violation
|
2
|
2
|
3
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
3
|
3
|
Baseline Characteristics
Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117)
Baseline characteristics by cohort
| Measure |
Placebo
n=149 Participants
Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Montelukast
n=155 Participants
Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Loratadine
n=301 Participants
Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Montelukast/Loratadine
n=302 Participants
Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
|
Total
n=907 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
36.9 Years
n=5 Participants
|
35.2 Years
n=7 Participants
|
37.1 Years
n=5 Participants
|
37.6 Years
n=4 Participants
|
36.9 Years
n=21 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
191 Participants
n=5 Participants
|
208 Participants
n=4 Participants
|
587 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
320 Participants
n=21 Participants
|
|
Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms)
|
1.71 Units on a Scale
STANDARD_DEVIATION 0.45 • n=5 Participants
|
1.82 Units on a Scale
STANDARD_DEVIATION 0.43 • n=7 Participants
|
1.82 Units on a Scale
STANDARD_DEVIATION 0.45 • n=5 Participants
|
1.78 Units on a Scale
STANDARD_DEVIATION 0.46 • n=4 Participants
|
1.79 Units on a Scale
STANDARD_DEVIATION 0.45 • n=21 Participants
|
|
Daytime Congestion score
|
2.26 Units on a Scale
STANDARD_DEVIATION 0.56 • n=5 Participants
|
2.31 Units on a Scale
STANDARD_DEVIATION 0.50 • n=7 Participants
|
2.37 Units on a Scale
STANDARD_DEVIATION 0.52 • n=5 Participants
|
2.31 Units on a Scale
STANDARD_DEVIATION 0.58 • n=4 Participants
|
2.32 Units on a Scale
STANDARD_DEVIATION 0.54 • n=21 Participants
|
|
Daytime Eye Symptoms Score
|
1.31 Units on a Scale
STANDARD_DEVIATION 0.73 • n=5 Participants
|
1.38 Units on a Scale
STANDARD_DEVIATION 0.73 • n=7 Participants
|
1.38 Units on a Scale
STANDARD_DEVIATION 0.78 • n=5 Participants
|
1.38 Units on a Scale
STANDARD_DEVIATION 0.77 • n=4 Participants
|
1.37 Units on a Scale
STANDARD_DEVIATION 0.76 • n=21 Participants
|
|
Daytime Nasal Itching score
|
1.94 Units on a Scale
STANDARD_DEVIATION 0.67 • n=5 Participants
|
1.94 Units on a Scale
STANDARD_DEVIATION 0.70 • n=7 Participants
|
1.93 Units on a Scale
STANDARD_DEVIATION 0.79 • n=5 Participants
|
1.89 Units on a Scale
STANDARD_DEVIATION 0.73 • n=4 Participants
|
1.92 Units on a Scale
STANDARD_DEVIATION 0.74 • n=21 Participants
|
|
Daytime Nasal Symptoms Score
|
2.01 Units on a Scale
STANDARD_DEVIATION 0.44 • n=5 Participants
|
2.06 Units on a Scale
STANDARD_DEVIATION 0.39 • n=7 Participants
|
2.09 Units on a Scale
STANDARD_DEVIATION 0.44 • n=5 Participants
|
2.01 Units on a Scale
STANDARD_DEVIATION 0.43 • n=4 Participants
|
2.04 Units on a Scale
STANDARD_DEVIATION 0.43 • n=21 Participants
|
|
Daytime Rhinorrhea score
|
2.02 Units on a Scale
STANDARD_DEVIATION 0.70 • n=5 Participants
|
2.05 Units on a Scale
STANDARD_DEVIATION 0.61 • n=7 Participants
|
2.16 Units on a Scale
STANDARD_DEVIATION 0.58 • n=5 Participants
|
1.98 Units on a Scale
STANDARD_DEVIATION 0.66 • n=4 Participants
|
2.06 Units on a Scale
STANDARD_DEVIATION 0.64 • n=21 Participants
|
|
Daytime Sneezing score
|
1.81 Units on a Scale
STANDARD_DEVIATION 0.74 • n=5 Participants
|
1.93 Units on a Scale
STANDARD_DEVIATION 0.65 • n=7 Participants
|
1.89 Units on a Scale
STANDARD_DEVIATION 0.74 • n=5 Participants
|
1.87 Units on a Scale
STANDARD_DEVIATION 0.68 • n=4 Participants
|
1.87 Units on a Scale
STANDARD_DEVIATION 0.71 • n=21 Participants
|
|
Nasal Congestion Upon Awakening
|
2.17 Units on a Scale
STANDARD_DEVIATION 0.65 • n=5 Participants
|
2.25 Units on a Scale
STANDARD_DEVIATION 0.56 • n=7 Participants
|
2.26 Units on a Scale
STANDARD_DEVIATION 0.61 • n=5 Participants
|
2.20 Units on a Scale
STANDARD_DEVIATION 0.63 • n=4 Participants
|
2.23 Units on a Scale
STANDARD_DEVIATION 0.62 • n=21 Participants
|
|
Nighttime Symptoms Score
|
1.32 Units on a Scale
STANDARD_DEVIATION 0.65 • n=5 Participants
|
1.50 Units on a Scale
STANDARD_DEVIATION 0.64 • n=7 Participants
|
1.47 Units on a Scale
STANDARD_DEVIATION 0.63 • n=5 Participants
|
1.46 Units on a Scale
STANDARD_DEVIATION 0.66 • n=4 Participants
|
1.45 Units on a Scale
STANDARD_DEVIATION 0.65 • n=21 Participants
|
|
Rhinoconjunctivitis Quality-of-Life Score
|
3.06 Units on a Scale
STANDARD_DEVIATION 1.09 • n=5 Participants
|
3.14 Units on a Scale
STANDARD_DEVIATION 0.98 • n=7 Participants
|
3.10 Units on a Scale
STANDARD_DEVIATION 1.02 • n=5 Participants
|
3.25 Units on a Scale
STANDARD_DEVIATION 1.08 • n=4 Participants
|
3.15 Units on a Scale
STANDARD_DEVIATION 1.05 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 2Population: The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., 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 of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale (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 |
Placebo
n=148 Participants
Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Montelukast
n=151 Participants
Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Loratadine
n=300 Participants
Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Montelukast/Loratadine
n=298 Participants
Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
|
|---|---|---|---|---|
|
Mean Change From Baseline in Daytime Nasal Symptoms Score
|
-0.26 Units on a Scale
Interval -0.34 to -0.17
|
-0.48 Units on a Scale
Interval -0.57 to -0.4
|
-0.52 Units on a Scale
Interval -0.58 to -0.46
|
-0.58 Units on a Scale
Interval -0.64 to -0.51
|
SECONDARY outcome
Timeframe: Baseline and Week 2Population: The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., 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 (0 (best) to 3 (worst)), and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score.
Outcome measures
| Measure |
Placebo
n=148 Participants
Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Montelukast
n=151 Participants
Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Loratadine
n=300 Participants
Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Montelukast/Loratadine
n=299 Participants
Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
|
|---|---|---|---|---|
|
Mean Change From Baseline in Nighttime Symptoms Score
|
-0.12 Units on a Scale
Interval -0.2 to -0.04
|
-0.29 Units on a Scale
Interval -0.37 to -0.22
|
-0.26 Units on a Scale
Interval -0.31 to -0.2
|
-0.28 Units on a Scale
Interval -0.34 to -0.23
|
SECONDARY outcome
Timeframe: Baseline and Week 2Population: The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., 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 and Nighttime Symptoms scores collected on a 4 point scale (0 (best) to 3 (worst)).
Outcome measures
| Measure |
Placebo
n=148 Participants
Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Montelukast
n=152 Participants
Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Loratadine
n=300 Participants
Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Montelukast/Loratadine
n=300 Participants
Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
|
|---|---|---|---|---|
|
Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms)
|
-0.2 Units on a Scale
Interval -0.28 to -0.12
|
-0.40 Units on a Scale
Interval -0.48 to -0.33
|
-0.41 Units on a Scale
Interval -0.47 to -0.35
|
-0.45 Units on a Scale
Interval -0.5 to -0.39
|
SECONDARY outcome
Timeframe: Baseline and Week 2Population: The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.
Mean change from baseline in Daytime Eye Symptoms scores. Patients were asked to rate each of the 4 eye symptom of tearing, itchy, red, and puffy eyes daily on a 4-point scale (0 (best) to 3 (worst)). The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score.
Outcome measures
| Measure |
Placebo
n=148 Participants
Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Montelukast
n=151 Participants
Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Loratadine
n=299 Participants
Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Montelukast/Loratadine
n=298 Participants
Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
|
|---|---|---|---|---|
|
Mean Change From Baseline in Daytime Eye Symptoms Score
|
-0.14 Units on a Scale
Interval -0.23 to -0.06
|
-0.35 Units on a Scale
Interval -0.43 to -0.26
|
-0.38 Units on a Scale
Interval -0.44 to -0.23
|
-0.41 Units on a Scale
Interval -0.47 to -0.35
|
SECONDARY outcome
Timeframe: Baseline and Week 2Population: The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.
Patients were asked to rate the nasal symptom of Congestion daily on a 4-point scale (0 (best) to 3 (worst)).
Outcome measures
| Measure |
Placebo
n=148 Participants
Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Montelukast
n=151 Participants
Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Loratadine
n=300 Participants
Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Montelukast/Loratadine
n=298 Participants
Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
|
|---|---|---|---|---|
|
Mean Change From Baseline in Daytime Nasal Congestion Score
|
-0.19 Units on a Scale
Interval -0.29 to -0.09
|
-0.41 Units on a Scale
Interval -0.51 to -0.31
|
-0.39 Units on a Scale
Interval -0.46 to -0.32
|
-0.43 Units on a Scale
Interval -0.5 to -0.36
|
SECONDARY outcome
Timeframe: Baseline and Week 2Population: The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.
Patients were asked to rate the nasal symptom of Rhinorrhea daily on a 4-point scale (0 (best) to 3 (worst)).
Outcome measures
| Measure |
Placebo
n=148 Participants
Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Montelukast
n=151 Participants
Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Loratadine
n=300 Participants
Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Montelukast/Loratadine
n=298 Participants
Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
|
|---|---|---|---|---|
|
Mean Change From Baseline in Daytime Rhinorrhea Score
|
-0.25 Units on a Scale
Interval -0.36 to -0.15
|
-0.53 Units on a Scale
Interval -0.64 to -0.43
|
-0.51 Units on a Scale
Interval -0.58 to -0.43
|
-0.59 Units on a Scale
Interval -0.67 to -0.52
|
SECONDARY outcome
Timeframe: Baseline and Week 2Population: The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.
Patients were asked to rate the nasal symptom of Nasal Itching daily on a 4-point scale (0 (best) to 3 (worst)).
Outcome measures
| Measure |
Placebo
n=148 Participants
Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Montelukast
n=151 Participants
Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Loratadine
n=300 Participants
Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Montelukast/Loratadine
n=298 Participants
Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
|
|---|---|---|---|---|
|
Mean Change From Baseline in Daytime Nasal Itching Score
|
-0.26 Units on a Scale
Interval -0.37 to -0.16
|
-0.49 Units on a Scale
Interval -0.6 to -0.39
|
-0.56 Units on a Scale
Interval -0.64 to -0.48
|
-0.62 Units on a Scale
Interval -0.7 to -0.55
|
SECONDARY outcome
Timeframe: Baseline and Week 2Population: The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.
Patients were asked to rate the nasal symptom of Sneezing daily on a 4-point scale (0 (best) to 3 (worst)).
Outcome measures
| Measure |
Placebo
n=133 Participants
Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Montelukast
n=138 Participants
Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Loratadine
n=278 Participants
Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Montelukast/Loratadine
n=272 Participants
Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
|
|---|---|---|---|---|
|
Mean Change From Baseline in Daytime Sneezing Score
|
-0.26 Units on a Scale
Interval -0.36 to -0.15
|
-0.46 Units on a Scale
Interval -0.57 to -0.36
|
-0.59 Units on a Scale
Interval -0.66 to -0.51
|
-0.67 Units on a Scale
Interval -0.75 to -0.59
|
SECONDARY outcome
Timeframe: Baseline and Week 2Population: The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.
Patients were asked to rate the symptom of Nasal Congestion Upon Awakening daily on a 4-point scale (0 (best) to 3 (worst)).
Outcome measures
| Measure |
Placebo
n=148 Participants
Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Montelukast
n=151 Participants
Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Loratadine
n=300 Participants
Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Montelukast/Loratadine
n=299 Participants
Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
|
|---|---|---|---|---|
|
Mean Change From Baseline in Nasal Congestion Upon Awakening
|
-0.15 Units on a Scale
Interval -0.25 to -0.06
|
-0.35 Units on a Scale
Interval -0.44 to -0.25
|
-0.30 Units on a Scale
Interval -0.37 to -0.23
|
-0.32 Units on a Scale
Interval -0.39 to -0.25
|
SECONDARY outcome
Timeframe: Week 2Population: 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 the last visit (or upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).
Outcome measures
| Measure |
Placebo
n=148 Participants
Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Montelukast
n=153 Participants
Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Loratadine
n=298 Participants
Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Montelukast/Loratadine
n=298 Participants
Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
|
|---|---|---|---|---|
|
Patient's Global Evaluation of Allergic Rhinitis
|
2.37 Units on a Scale
Interval 2.13 to 2.61
|
2.10 Units on a Scale
Interval 1.86 to 2.33
|
2.00 Units on a Scale
Interval 1.83 to 2.17
|
1.92 Units on a Scale
Interval 1.74 to 2.09
|
SECONDARY outcome
Timeframe: Week 2Population: 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 the last visit (or upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).
Outcome measures
| Measure |
Placebo
n=147 Participants
Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Montelukast
n=153 Participants
Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Loratadine
n=299 Participants
Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Montelukast/Loratadine
n=299 Participants
Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
|
|---|---|---|---|---|
|
Physician's Global Evaluation of Allergic Rhinitis
|
2.35 Units on a Scale
Interval 2.15 to 2.56
|
2.13 Units on a Scale
Interval 1.93 to 2.33
|
2.05 Units on a Scale
Interval 1.9 to 2.19
|
1.99 Units on a Scale
Interval 1.84 to 2.13
|
SECONDARY outcome
Timeframe: Week 2Population: The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included. No missing values were imputed.
Patients completed a Rhinoconjunctivitis Quality-of-Life Questionnaire, 28 questions on a 7-point scale \[0(best) to 6(worst)\] across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, emotional. Scores per domain were averaged, then scores for the 7 domains were averaged for an overall score.
Outcome measures
| Measure |
Placebo
n=147 Participants
Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Montelukast
n=153 Participants
Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Loratadine
n=298 Participants
Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Montelukast/Loratadine
n=299 Participants
Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
|
|---|---|---|---|---|
|
Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score
|
-0.80 Units on a Scale
Interval -0.98 to -0.63
|
-1.09 Units on a Scale
Interval -1.26 to -0.92
|
-1.06 Units on a Scale
Interval -1.19 to -0.93
|
-1.16 Units on a Scale
Interval -1.29 to -1.03
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Montelukast
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Loratadine
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Montelukast/Loratadine
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=149 participants at risk
Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Montelukast
n=155 participants at risk
Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Loratadine
n=301 participants at risk
Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Montelukast/Loratadine
n=302 participants at risk
Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
|
|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.67%
1/149 • During the 2 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy.
Although a patient may have had two or more adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.00%
0/155 • During the 2 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy.
Although a patient may have had two or more adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.00%
0/301 • During the 2 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy.
Although a patient may have had two or more adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.00%
0/302 • During the 2 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy.
Although a patient may have had two or more adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
Other adverse events
| Measure |
Placebo
n=149 participants at risk
Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Montelukast
n=155 participants at risk
Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Loratadine
n=301 participants at risk
Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
|
Montelukast/Loratadine
n=302 participants at risk
Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
5.4%
8/149 • During the 2 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy.
Although a patient may have had two or more adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
3.2%
5/155 • During the 2 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy.
Although a patient may have had two or more adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
4.3%
13/301 • During the 2 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy.
Although a patient may have had two or more adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
3.3%
10/302 • During the 2 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy.
Although a patient may have had two or more adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
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