Trial Outcomes & Findings for A Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis (MK-0476-192)(COMPLETED) (NCT NCT00960141)
NCT ID: NCT00960141
Last Updated: 2022-02-03
Results Overview
Mean change from baseline in Daytime Nasal Symptoms score on a 4-point scale \[0(best) to 3(worst)\]. The average of the 4 individual nasal symptoms scores (Congestion, Rhinorrhea, Itching, and Sneezing) was reported as the Daytime Nasal Symptoms Score.
COMPLETED
PHASE3
829 participants
Baseline and Week 2
2022-02-03
Participant Flow
Twenty-nine study centers in the United States. Therapy Period: August 2000 to October 2000
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
Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
|
Montelukast
Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
|
Loratadine
Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
333
|
326
|
170
|
|
Overall Study
COMPLETED
|
323
|
309
|
163
|
|
Overall Study
NOT COMPLETED
|
10
|
17
|
7
|
Reasons for withdrawal
| Measure |
Placebo
Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
|
Montelukast
Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
|
Loratadine
Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
8
|
2
|
|
Overall Study
Lack of Efficacy
|
3
|
4
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
1
|
Baseline Characteristics
A Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis (MK-0476-192)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Placebo
n=333 Participants
Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
|
Montelukast
n=326 Participants
Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
|
Loratadine
n=170 Participants
Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
|
Total
n=829 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
36.4 years
n=5 Participants
|
36.3 years
n=7 Participants
|
37.5 years
n=5 Participants
|
36.6 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
222 Participants
n=5 Participants
|
227 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
568 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
111 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
261 Participants
n=4 Participants
|
|
Daytime Eye Symptoms score
|
1.46 Units on a Scale
STANDARD_DEVIATION 0.78 • n=5 Participants
|
1.46 Units on a Scale
STANDARD_DEVIATION 0.76 • n=7 Participants
|
1.44 Units on a Scale
STANDARD_DEVIATION 0.80 • n=5 Participants
|
1.46 Units on a Scale
STANDARD_DEVIATION 0.77 • n=4 Participants
|
|
Daytime Nasal Symptoms Score
|
2.09 Units on a Scale
STANDARD_DEVIATION 0.44 • n=5 Participants
|
2.14 Units on a Scale
STANDARD_DEVIATION 0.43 • n=7 Participants
|
2.08 Units on a Scale
STANDARD_DEVIATION 0.40 • n=5 Participants
|
2.11 Units on a Scale
STANDARD_DEVIATION 0.43 • n=4 Participants
|
|
Nighttime Symptoms Score
|
1.53 Units on a Scale
STANDARD_DEVIATION 0.62 • n=5 Participants
|
1.49 Units on a Scale
STANDARD_DEVIATION 0.60 • n=7 Participants
|
1.54 Units on a Scale
STANDARD_DEVIATION 0.68 • n=5 Participants
|
1.52 Units on a Scale
STANDARD_DEVIATION 0.62 • n=4 Participants
|
|
Rhinoconjunctivitis Quality-of-Life score
|
3.18 Units on a Scale
STANDARD_DEVIATION 1.00 • n=5 Participants
|
3.20 Units on a Scale
STANDARD_DEVIATION 1.00 • n=7 Participants
|
3.26 Units on a Scale
STANDARD_DEVIATION 1.08 • n=5 Participants
|
3.20 Units on a Scale
STANDARD_DEVIATION 1.02 • n=4 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 on a 4-point scale \[0(best) to 3(worst)\]. The average of the 4 individual nasal symptoms scores (Congestion, Rhinorrhea, Itching, and Sneezing) was reported as the Daytime Nasal Symptoms Score.
Outcome measures
| Measure |
Placebo
n=331 Participants
Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
|
Montelukast
n=326 Participants
Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
|
Loratadine
n=163 Participants
Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
|
|---|---|---|---|
|
Mean Change From Baseline in Daytime Nasal Symptoms Score
|
-0.32 Units on a Scale
Interval -0.37 to -0.26
|
-0.38 Units on a Scale
Interval -0.44 to -0.32
|
-0.47 Units on a Scale
Interval -0.55 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 Nighttime Symptoms Score on a 4-point scale \[0(best) to 3(worst)\]. The average of 3 scores (Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings) was reported as the Nighttime Symptoms Score.
Outcome measures
| Measure |
Placebo
n=331 Participants
Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
|
Montelukast
n=326 Participants
Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
|
Loratadine
n=163 Participants
Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
|
|---|---|---|---|
|
Mean Change From Baseline in Nighttime Symptoms Score
|
-0.18 Units on a Scale
Interval -0.23 to -0.13
|
-0.28 Units on a Scale
Interval -0.33 to -0.23
|
-0.26 Units on a Scale
Interval -0.34 to -0.19
|
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 on a 4-point scale \[0(best) to 3(worst)\]. The average of the 4 individual eye symptoms scores (tearing, itchy, red, and puffy eyes) was reported as the Daytime Eye Symptoms Score.
Outcome measures
| Measure |
Placebo
n=331 Participants
Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
|
Montelukast
n=326 Participants
Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
|
Loratadine
n=163 Participants
Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
|
|---|---|---|---|
|
Mean Change From Baseline in Daytime Eye Symptoms Score
|
-0.23 Units on a Scale
Interval -0.28 to -0.17
|
-0.29 Units on a Scale
Interval -0.35 to -0.24
|
-0.35 Units on a Scale
Interval -0.43 to -0.28
|
SECONDARY outcome
Timeframe: Week 2 (or upon discontinuation)Population: The primary efficacy analyses were based on the intention-to-treat. 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, in answer to a single question regarding 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=333 Participants
Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
|
Montelukast
n=324 Participants
Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
|
Loratadine
n=169 Participants
Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
|
|---|---|---|---|
|
Patient's Global Evaluation of Allergic Rhinitis
|
2.62 Units on a Scale
Interval 2.45 to 2.78
|
2.43 Units on a Scale
Interval 2.26 to 2.6
|
2.27 Units on a Scale
Interval 2.04 to 2.5
|
SECONDARY outcome
Timeframe: Week 2Population: The primary efficacy analyses were based on the intention-to-treat. 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=331 Participants
Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
|
Montelukast
n=324 Participants
Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
|
Loratadine
n=169 Participants
Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
|
|---|---|---|---|
|
Physician's Global Evaluation of Allergic Rhinitis
|
2.53 Units on a Scale
Interval 2.38 to 2.68
|
2.35 Units on a Scale
Interval 2.2 to 2.5
|
2.26 Units on a Scale
Interval 2.05 to 2.46
|
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. No missing values were imputed.
Patients completed a validated, self-administered questionnaire, which included 28 questions on a 7-point scale \[score 0 (best) to 6 (worst)\] across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The scores for each domain were averaged, then the scores for the 7 domains were averaged for the overall score.
Outcome measures
| Measure |
Placebo
n=330 Participants
Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
|
Montelukast
n=324 Participants
Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
|
Loratadine
n=168 Participants
Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
|
|---|---|---|---|
|
Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score
|
-0.75 Units on a Scale
Interval -0.86 to -0.63
|
-0.85 Units on a Scale
Interval -0.96 to -0.73
|
-0.97 Units on a Scale
Interval -1.13 to -0.82
|
Adverse Events
Placebo
Montelukast
Loratadine
Serious adverse events
| Measure |
Placebo
n=333 participants at risk
Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
|
Montelukast
n=326 participants at risk
Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
|
Loratadine
n=170 participants at risk
Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
|
|---|---|---|---|
|
Psychiatric disorders
Depression
|
0.00%
0/333 • Over the 2-week treatment period and including 14 days follow-up post-treatment
|
0.31%
1/326 • Over the 2-week treatment period and including 14 days follow-up post-treatment
|
0.00%
0/170 • Over the 2-week treatment period and including 14 days follow-up post-treatment
|
Other adverse events
| Measure |
Placebo
n=333 participants at risk
Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
|
Montelukast
n=326 participants at risk
Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
|
Loratadine
n=170 participants at risk
Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
5.7%
19/333 • Over the 2-week treatment period and including 14 days follow-up post-treatment
|
4.0%
13/326 • Over the 2-week treatment period and including 14 days follow-up post-treatment
|
4.7%
8/170 • Over the 2-week treatment period and including 14 days follow-up post-treatment
|
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