Trial Outcomes & Findings for The Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis (0476-265) (NCT NCT00092118)
NCT ID: NCT00092118
Last Updated: 2022-02-03
Results Overview
Mean change from baseline in Daytime Nasal Symptoms score averaged over the 6-week treatment period. The Daytime Nasal Symptoms score was calculated as the average of the 3 individual scores for Congestion, Rhinorrhea, and Sneezing, each rated by patients daily on a 4-point scale \[Score 0 (best) to 3 (worst)\].
COMPLETED
PHASE3
1992 participants
6 week treatment period (from baseline though the end of week 6)
2022-02-03
Participant Flow
Patients were screened at 122 sites worldwide. Primary therapy period: Oct 2003 to May 2004
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 placebo tablets were taken orally once daily at bedtime for 6 weeks.
|
Montelukast 10 mg
Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
990
|
1002
|
|
Overall Study
COMPLETED
|
906
|
913
|
|
Overall Study
NOT COMPLETED
|
84
|
89
|
Reasons for withdrawal
| Measure |
Placebo
Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.
|
Montelukast 10 mg
Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
35
|
32
|
|
Overall Study
Lack of Efficacy
|
12
|
14
|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
|
Overall Study
Protocol Violation
|
23
|
25
|
|
Overall Study
Withdrawal by Subject
|
4
|
10
|
|
Overall Study
Other
|
6
|
5
|
Baseline Characteristics
The Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis (0476-265)
Baseline characteristics by cohort
| Measure |
Placebo
n=990 Participants
Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.
|
Montelukast 10 mg
n=1002 Participants
Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.
|
Total
n=1992 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.6 years
STANDARD_DEVIATION 13.12 • n=99 Participants
|
36.3 years
STANDARD_DEVIATION 13.61 • n=107 Participants
|
36.4 years
STANDARD_DEVIATION 13.36 • n=206 Participants
|
|
Sex: Female, Male
Female
|
632 Participants
n=99 Participants
|
644 Participants
n=107 Participants
|
1276 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
358 Participants
n=99 Participants
|
358 Participants
n=107 Participants
|
716 Participants
n=206 Participants
|
|
Daytime nasal symptoms score
|
2.10 Scores on a scale
STANDARD_DEVIATION 0.41 • n=99 Participants
|
2.09 Scores on a scale
STANDARD_DEVIATION 0.40 • n=107 Participants
|
2.10 Scores on a scale
STANDARD_DEVIATION 0.41 • n=206 Participants
|
|
Rhinoconjunctivitis Quality-of-Life Score
|
2.96 Score on a scale
STANDARD_DEVIATION 1.10 • n=99 Participants
|
2.94 Score on a scale
STANDARD_DEVIATION 1.04 • n=107 Participants
|
2.95 Score on a scale
STANDARD_DEVIATION 1.07 • n=206 Participants
|
PRIMARY outcome
Timeframe: 6 week treatment period (from baseline though the end of week 6)Population: The primary efficacy analyses were performed using a modified intention-to-treat (MITT) approach. All patients with efficacy measurements, both at baseline and during the treatment period were included.
Mean change from baseline in Daytime Nasal Symptoms score averaged over the 6-week treatment period. The Daytime Nasal Symptoms score was calculated as the average of the 3 individual scores for Congestion, Rhinorrhea, and Sneezing, each rated by patients daily on a 4-point scale \[Score 0 (best) to 3 (worst)\].
Outcome measures
| Measure |
Placebo
n=980 Participants
Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.
|
Montelukast 10 mg
n=1000 Participants
Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.
|
|---|---|---|
|
Mean Change From Baseline in Daytime Nasal Symptoms Score Averaged Over the 6-week Treatment Period in Patients With Perennial Allergic Rhinitis
|
-0.37 Score on a scale
Interval -0.4 to -0.34
|
-0.44 Score on a scale
Interval -0.48 to -0.41
|
SECONDARY outcome
Timeframe: At the end of the 6 week treatment periodPopulation: The analysis was performed using a modified intention-to-treat (MITT) approach. Patients were excluded if no treatment period data were available.
An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale \[Score 0 (best) to 6 (worst)\], in answer to a single question regarding the change in symptoms as compared to the beginning of the study.
Outcome measures
| Measure |
Placebo
n=969 Participants
Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.
|
Montelukast 10 mg
n=977 Participants
Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.
|
|---|---|---|
|
Patient's Global Evaluation of Allergic Rhinitis at the End of the 6 Week Treatment Period
|
2.42 Score on a scale
Interval 2.33 to 2.51
|
2.27 Score on a scale
Interval 2.18 to 2.35
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: The primary efficacy analyses were performed using a modified intention-to-treat (MITT) approach. Patients were excluded if no baseline or treatment period data were available
Patients completed the validated, self-administered RQLQ which included 28 items on a 7-point scale \[Score 0 (best) to 6 (worst)\] across 7 domains: activities, sleep, nonnose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The scores for each domain were averaged, then scores for the 7 domains were averaged to obtain the overall score.
Outcome measures
| Measure |
Placebo
n=969 Participants
Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.
|
Montelukast 10 mg
n=977 Participants
Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.
|
|---|---|---|
|
Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score After the 6 Week Treatment Period
|
-0.69 Score on a scale
Interval -0.76 to -0.62
|
-0.84 Score on a scale
Interval -0.91 to -0.77
|
Adverse Events
Placebo
Montelukast 10 mg
Serious adverse events
| Measure |
Placebo
n=990 participants at risk
Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.
|
Montelukast 10 mg
n=1002 participants at risk
Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.
|
|---|---|---|
|
Cardiac disorders
Myocardial Infarction
|
0.10%
1/990 • Adverse events (AEs) were collected 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 participants listed in the AE tables (990 placebo \& 1002 montelukast) is the number that received treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.00%
0/1002 • Adverse events (AEs) were collected 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 participants listed in the AE tables (990 placebo \& 1002 montelukast) is the number that received treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.00%
0/990 • Adverse events (AEs) were collected 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 participants listed in the AE tables (990 placebo \& 1002 montelukast) is the number that received treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.10%
1/1002 • Adverse events (AEs) were collected 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 participants listed in the AE tables (990 placebo \& 1002 montelukast) is the number that received treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/990 • Adverse events (AEs) were collected 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 participants listed in the AE tables (990 placebo \& 1002 montelukast) is the number that received treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.10%
1/1002 • Adverse events (AEs) were collected 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 participants listed in the AE tables (990 placebo \& 1002 montelukast) is the number that received treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Psychiatric disorders
Anxiety Disorder
|
0.00%
0/990 • Adverse events (AEs) were collected 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 participants listed in the AE tables (990 placebo \& 1002 montelukast) is the number that received treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.10%
1/1002 • Adverse events (AEs) were collected 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 participants listed in the AE tables (990 placebo \& 1002 montelukast) is the number that received treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/990 • Adverse events (AEs) were collected 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 participants listed in the AE tables (990 placebo \& 1002 montelukast) is the number that received treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.10%
1/1002 • Adverse events (AEs) were collected 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 participants listed in the AE tables (990 placebo \& 1002 montelukast) is the number that received treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
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