Trial Outcomes & Findings for Montelukast in Patients With Seasonal Allergic Rhinitis - Spring 2000 Study (MK-0476A-162)(COMPLETED) (NCT NCT00979901)
NCT ID: NCT00979901
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. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score. Scores were measured as 0 (best) to 3 (worst).
COMPLETED
PHASE3
1577 participants
Baseline and Week 2
2022-02-09
Participant Flow
Patients were recruited at 50 sites (43 in the US and 7 in Canada). Primary Therapy Period: March 2000 to July 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
Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
|
Montelukast 10 mg
Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
|
Loratadine 10 mg
Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
|
Montelukast/Loratadine
Montelukast matching-image placebo tablet, loratadine matching-image placebo tablet, and montelukast 10 mg/loratadine 10 mg combination tablet taken orally once daily at bedtime for 2 weeks. During the study, patients in the montelukast/loratadine combination treatment group were discontinued from further participation due to a business decision by the sponsor.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
352
|
348
|
602
|
275
|
|
Overall Study
COMPLETED
|
334
|
336
|
573
|
159
|
|
Overall Study
NOT COMPLETED
|
18
|
12
|
29
|
116
|
Reasons for withdrawal
| Measure |
Placebo
Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
|
Montelukast 10 mg
Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
|
Loratadine 10 mg
Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
|
Montelukast/Loratadine
Montelukast matching-image placebo tablet, loratadine matching-image placebo tablet, and montelukast 10 mg/loratadine 10 mg combination tablet taken orally once daily at bedtime for 2 weeks. During the study, patients in the montelukast/loratadine combination treatment group were discontinued from further participation due to a business decision by the sponsor.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
3
|
9
|
2
|
|
Overall Study
Lack of Efficacy
|
8
|
4
|
9
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
2
|
0
|
|
Overall Study
Protocol Violation
|
2
|
2
|
7
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
1
|
1
|
|
Overall Study
Noncompliance
|
1
|
0
|
0
|
0
|
|
Overall Study
out-of-state
|
1
|
0
|
0
|
0
|
|
Overall Study
vacation
|
1
|
0
|
0
|
0
|
|
Overall Study
elevated lab values pre-randomization
|
1
|
0
|
0
|
0
|
|
Overall Study
Discontinued in Error
|
0
|
1
|
0
|
0
|
|
Overall Study
Left Country
|
0
|
0
|
1
|
0
|
|
Overall Study
Treatment Group Terminated by Sponsor
|
0
|
0
|
0
|
112
|
Baseline Characteristics
Montelukast in Patients With Seasonal Allergic Rhinitis - Spring 2000 Study (MK-0476A-162)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Placebo
n=352 Participants
Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
|
Montelukast 10 mg
n=348 Participants
Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
|
Loratadine 10 mg
n=602 Participants
Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
|
Montelukast/Loratadine
n=275 Participants
Montelukast matching-image placebo tablet, loratadine matching-image placebo tablet, and montelukast 10 mg/loratadine 10 mg combination tablet taken orally once daily at bedtime for 2 weeks. During the study, patients in the montelukast/loratadine combination treatment group were discontinued from further participation due to a business decision by the sponsor.
|
Total
n=1577 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
35.9 Years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
36.5 Years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
36.3 Years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
37.1 Years
STANDARD_DEVIATION 11.95 • n=4 Participants
|
36.39 Years
STANDARD_DEVIATION 12.61 • n=21 Participants
|
|
Sex: Female, Male
Female
|
229 Participants
n=5 Participants
|
233 Participants
n=7 Participants
|
390 Participants
n=5 Participants
|
184 Participants
n=4 Participants
|
1036 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
123 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
212 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
541 Participants
n=21 Participants
|
|
Daytime eye symptoms score
|
1.44 Units on a Scale
STANDARD_DEVIATION 0.78 • n=5 Participants
|
1.39 Units on a Scale
STANDARD_DEVIATION 0.77 • n=7 Participants
|
1.40 Units on a Scale
STANDARD_DEVIATION 0.76 • n=5 Participants
|
0 Units on a Scale
STANDARD_DEVIATION 0 • n=4 Participants
|
1.41 Units on a Scale
STANDARD_DEVIATION 0.77 • n=21 Participants
|
|
Daytime nasal symptoms score
|
2.10 Units on a Scale
STANDARD_DEVIATION 0.43 • n=5 Participants
|
2.09 Units on a Scale
STANDARD_DEVIATION 0.44 • n=7 Participants
|
2.06 Units on a Scale
STANDARD_DEVIATION 0.41 • n=5 Participants
|
0 Units on a Scale
STANDARD_DEVIATION 0 • n=4 Participants
|
2.08 Units on a Scale
STANDARD_DEVIATION 0.43 • n=21 Participants
|
|
Nighttime symptoms score
|
1.46 Units on a Scale
STANDARD_DEVIATION 0.66 • n=5 Participants
|
1.43 Units on a Scale
STANDARD_DEVIATION 0.64 • n=7 Participants
|
1.45 Units on a Scale
STANDARD_DEVIATION 0.64 • n=5 Participants
|
0 Units on a Scale
STANDARD_DEVIATION 0 • n=4 Participants
|
1.45 Units on a Scale
STANDARD_DEVIATION 0.65 • n=21 Participants
|
|
Rhinoconjunctivitis quality-of-life questionnaire (RQLQ) overall score
|
3.22 Units on a Scale
STANDARD_DEVIATION 0.99 • n=5 Participants
|
3.12 Units on a Scale
STANDARD_DEVIATION 0.99 • n=7 Participants
|
3.09 Units on a Scale
STANDARD_DEVIATION 1.03 • n=5 Participants
|
0 Units on a Scale
STANDARD_DEVIATION 0 • n=4 Participants
|
3.13 Units on a Scale
STANDARD_DEVIATION 1.01 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 2Population: The primary efficacy analysis was based on the ITT (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. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score. Scores were measured as 0 (best) to 3 (worst).
Outcome measures
| Measure |
Placebo
n=351 Participants
Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
|
Montelukast 10 mg
n=344 Participants
Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
|
Loratadine 10 mg
n=599 Participants
Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
|
|---|---|---|---|
|
Mean Change From Baseline in Daytime Nasal Symptoms Score Over 2 Weeks
|
-0.24 Units on a Scale
Interval -0.29 to -0.18
|
-0.37 Units on a Scale
Interval -0.43 to -0.31
|
-0.47 Units on a Scale
Interval -0.52 to -0.43
|
SECONDARY outcome
Timeframe: Baseline and Week 2Population: The secondary efficacy analyses were based on the ITT (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, and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score. Scores were measured as 0 (best) to 3 (worst).
Outcome measures
| Measure |
Placebo
n=351 Participants
Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
|
Montelukast 10 mg
n=345 Participants
Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
|
Loratadine 10 mg
n=598 Participants
Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
|
|---|---|---|---|
|
Mean Change From Baseline in Nighttime Symptoms Score Over 2 Weeks
|
-0.14 Units on a Scale
Interval -0.19 to -0.09
|
-0.27 Units on a Scale
Interval -0.32 to -0.22
|
-0.23 Units on a Scale
Interval -0.27 to -0.19
|
SECONDARY outcome
Timeframe: Baseline and Week 2Population: The secondary efficacy analyses were based on the ITT (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 symptoms of tearing, itchy, red, and puffy eyes daily on a 4-point scale. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score. Scores were measured as 0 (best) to 3 (worst).
Outcome measures
| Measure |
Placebo
n=351 Participants
Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
|
Montelukast 10 mg
n=344 Participants
Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
|
Loratadine 10 mg
n=599 Participants
Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
|
|---|---|---|---|
|
Mean Change From Baseline in Daytime Eye Symptoms Score Over 2 Weeks
|
-0.12 Units on a Scale
Interval -0.17 to -0.06
|
-0.26 Units on a Scale
Interval -0.32 to -0.2
|
-0.32 Units on a Scale
Interval -0.36 to -0.28
|
SECONDARY outcome
Timeframe: Week 2Population: This secondary endpoint analysis was performed using the intention-to-treat approach. Patients were excluded if no treatment period data were available. 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. Scores were measured as 0 (best) to 6 (worst).
Outcome measures
| Measure |
Placebo
n=347 Participants
Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
|
Montelukast 10 mg
n=343 Participants
Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
|
Loratadine 10 mg
n=595 Participants
Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
|
|---|---|---|---|
|
Patient's Global Evaluation of Allergic Rhinitis at Week 2
|
2.62 Units on a Scale
Interval 2.46 to 2.79
|
2.20 Units on a Scale
Interval 2.04 to 2.36
|
2.13 Units on a Scale
Interval 2.01 to 2.25
|
SECONDARY outcome
Timeframe: Week 2Population: This secondary endpoint analysis was performed using the intention-to-treat approach. Patients were excluded if no treatment period data were available. 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. Scores were measured as 0 (best) to 6 (worst).
Outcome measures
| Measure |
Placebo
n=347 Participants
Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
|
Montelukast 10 mg
n=343 Participants
Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
|
Loratadine 10 mg
n=594 Participants
Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
|
|---|---|---|---|
|
Physician's Global Evaluation of Allergic Rhinitis at Week 2
|
2.53 Units on a Scale
Interval 2.38 to 2.67
|
2.23 Units on a Scale
Interval 2.08 to 2.37
|
2.17 Units on a Scale
Interval 2.06 to 2.29
|
SECONDARY outcome
Timeframe: Week 2Population: This secondary endpoint analysis was performed using the intention-to-treat approach. Patients were excluded if no baseline or treatment period data were available. No missing values were imputed.
Patients completed the validated, self-administered RQLQ, which included 28 items on a 7-point scale across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Scores for each domain were averaged, then scores for the 7 domains were averaged for the overall score. Scores were measured as 0 (best) to 6 (worst).
Outcome measures
| Measure |
Placebo
n=348 Participants
Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
|
Montelukast 10 mg
n=344 Participants
Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
|
Loratadine 10 mg
n=598 Participants
Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
|
|---|---|---|---|
|
Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score at Week 2
|
-0.65 Units on a Scale
Interval -0.76 to -0.53
|
-0.89 Units on a Scale
Interval -1.01 to -0.77
|
-0.99 Units on a Scale
Interval -1.08 to -0.9
|
Adverse Events
Placebo
Montelukast 10mg
Loratadine 10mg
Montelukast 10 mg + Loratadine 10 mg
Serious adverse events
| Measure |
Placebo
n=352 participants at risk
Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
|
Montelukast 10mg
n=348 participants at risk
Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
|
Loratadine 10mg
n=602 participants at risk
Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
|
Montelukast 10 mg + Loratadine 10 mg
n=275 participants at risk
Montelukast matching-image placebo tablet, loratadine matching-image placebo tablet, and montelukast 10 mg/loratadine 10 mg combination tablet taken orally once daily at bedtime for 2 weeks. During the study, patients in the montelukast/loratadine combination treatment group were discontinued from further participation due to a business decision by the sponsor.
|
|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.28%
1/352 • During the 2 week, double-blind treatment period, and up to and including 14 days (2 weeks) after the last dose of study therapy.
Patients with two or more specific adverse experiences may be counted more than once in different categories, but only once in each category. Thus the count of Specific Other AEs may not add up to the count of Overall Other AEs.
|
0.00%
0/348 • During the 2 week, double-blind treatment period, and up to and including 14 days (2 weeks) after the last dose of study therapy.
Patients with two or more specific adverse experiences may be counted more than once in different categories, but only once in each category. Thus the count of Specific Other AEs may not add up to the count of Overall Other AEs.
|
0.00%
0/602 • During the 2 week, double-blind treatment period, and up to and including 14 days (2 weeks) after the last dose of study therapy.
Patients with two or more specific adverse experiences may be counted more than once in different categories, but only once in each category. Thus the count of Specific Other AEs may not add up to the count of Overall Other AEs.
|
0.00%
0/275 • During the 2 week, double-blind treatment period, and up to and including 14 days (2 weeks) after the last dose of study therapy.
Patients with two or more specific adverse experiences may be counted more than once in different categories, but only once in each category. Thus the count of Specific Other AEs may not add up to the count of Overall Other AEs.
|
Other adverse events
Adverse event data not reported
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