Trial Outcomes & Findings for Montelukast in Seasonal Allergic Rhinitis: Fall 2001 Study (0476-240) (NCT NCT00963469)

NCT ID: NCT00963469

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 \[Score 0 (best) to 3 (worse)\]. 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: 1079 participants
• Primary outcome timeframe: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)
• Results posted on: 2022-02-03

Participant Flow

Forty-seven study centers in the United States. Prime Therapy Period: August 2001 to November 2001

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 tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks	Montelukast Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks	Loratadine Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
Overall Study STARTED	451	448	180
Overall Study COMPLETED	410	420	170
Overall Study NOT COMPLETED	41	28	10

Reasons for withdrawal

Measure	Placebo Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks	Montelukast Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks	Loratadine Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
Overall Study Adverse Event	15	11	1
Overall Study Lack of Efficacy	10	7	2
Overall Study Lost to Follow-up	1	1	0
Overall Study Protocol Violation	5	5	3
Overall Study Withdrawal by Subject	4	1	1
Overall Study Pre-randomization Adverse Event	1	2	0
Overall Study Moved	1	0	0
Overall Study Site closed (local pollen Season ended)	4	1	3

Baseline Characteristics

Montelukast in Seasonal Allergic Rhinitis: Fall 2001 Study (0476-240)

Baseline characteristics by cohort

Measure	Placebo n=451 Participants Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks	Montelukast n=448 Participants Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks	Loratadine n=180 Participants Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks	Total n=1079 Participants Total of all reporting groups
Age, Continuous	35.9 years n=5 Participants	35.5 years n=7 Participants	38.7 years n=5 Participants	36.2 years n=4 Participants
Sex: Female, Male Female	301 Participants n=5 Participants	301 Participants n=7 Participants	119 Participants n=5 Participants	721 Participants n=4 Participants
Sex: Female, Male Male	150 Participants n=5 Participants	147 Participants n=7 Participants	61 Participants n=5 Participants	358 Participants n=4 Participants
Composite Symptoms Score	1.94 Scores on a scale STANDARD_DEVIATION 0.46 • n=5 Participants	1.98 Scores on a scale STANDARD_DEVIATION 0.47 • n=7 Participants	2.03 Scores on a scale STANDARD_DEVIATION 0.46 • n=5 Participants	1.97 Scores on a scale STANDARD_DEVIATION 0.46 • n=4 Participants
Daytime Eye Symptoms score	1.61 Scores on a scale STANDARD_DEVIATION 0.81 • n=5 Participants	1.64 Scores on a scale STANDARD_DEVIATION 0.73 • n=7 Participants	1.64 Scores on a scale STANDARD_DEVIATION 0.78 • n=5 Participants	1.63 Scores on a scale STANDARD_DEVIATION 0.77 • n=4 Participants
Daytime Nasal Symptoms Score	2.16 Scores on a scale STANDARD_DEVIATION 0.44 • n=5 Participants	2.20 Scores on a scale STANDARD_DEVIATION 0.46 • n=7 Participants	2.23 Scores on a scale STANDARD_DEVIATION 0.44 • n=5 Participants	2.19 Scores on a scale STANDARD_DEVIATION 0.45 • n=4 Participants
Nighttime Symptoms Score	1.65 Scores on a scale STANDARD_DEVIATION 0.64 • n=5 Participants	1.69 Scores on a scale STANDARD_DEVIATION 0.64 • n=7 Participants	1.77 Scores on a scale STANDARD_DEVIATION 0.63 • n=5 Participants	1.69 Scores on a scale STANDARD_DEVIATION 0.64 • n=4 Participants
Rhinoconjunctivitis Quality of Life Score	3.37 Scores on a scale STANDARD_DEVIATION 1.02 • n=5 Participants	3.41 Scores on a scale STANDARD_DEVIATION 1.00 • n=7 Participants	3.46 Scores on a scale STANDARD_DEVIATION 1.08 • n=5 Participants	3.40 Scores on a scale STANDARD_DEVIATION 1.02 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)

Population: 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 through the first 2 weeks of treatment 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 (worse)]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score.

Outcome measures

Measure	Placebo n=448 Participants Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks	Montelukast n=445 Participants Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks	Loratadine n=180 Participants Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
Mean Change From Baseline in Daytime Nasal Symptoms Score Over First 2 Weeks of Treatment Period	-0.23 Scores on a scale Interval -0.28 to -0.18	-0.33 Scores on a scale Interval -0.37 to -0.28	-0.45 Scores on a scale Interval -0.52 to -0.37

SECONDARY outcome

Timeframe: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)

Population: 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 through the first 2 weeks of treatment 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 (worse)], 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=448 Participants Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks	Montelukast n=445 Participants Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks	Loratadine n=180 Participants Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
Mean Change From Baseline in Nighttime Symptoms Score Over First 2 Weeks of Treatment Period	-0.18 Scores on a scale Interval -0.23 to -0.14	-0.28 Scores on a scale Interval -0.32 to -0.23	-0.25 Scores on a scale Interval -0.32 to -0.19

SECONDARY outcome

Timeframe: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)

Population: 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 through the first 2 weeks of treatment were included

Composite Symptoms Scores were computed as the average of Daytime Nasal Scores [Score 0 (best) to 3 (worst)] and Nighttime Symptoms Scores [Score 0 (best) to 3 (worst)].

Outcome measures

Measure	Placebo n=448 Participants Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks	Montelukast n=445 Participants Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks	Loratadine n=180 Participants Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
Mean Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) Over First 2 Weeks of Treatment Period	-0.21 Scores on a scale Interval -0.25 to -0.16	-0.30 Scores on a scale Interval -0.35 to -0.26	-0.36 Scores on a scale Interval -0.43 to -0.3

SECONDARY outcome

Timeframe: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)

Population: 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 through the first 2 weeks of treatment 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 [Score 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=448 Participants Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks	Montelukast n=445 Participants Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks	Loratadine n=180 Participants Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
Mean Change From Baseline in Daytime Eye Symptoms Score Over First 2 Weeks of Treatment Period	-0.18 Scores on a scale Interval -0.23 to -0.14	-0.28 Scores on a scale Interval -0.33 to -0.23	-0.33 Scores on a scale Interval -0.41 to -0.26

SECONDARY outcome

Timeframe: After first 2 weeks of treatment

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 after the first 2 weeks of treatment 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	Placebo n=447 Participants Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks	Montelukast n=444 Participants Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks	Loratadine n=178 Participants Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
Patient's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment	2.73 Scores on a scale Interval 2.59 to 2.88	2.43 Scores on a scale Interval 2.29 to 2.57	2.30 Scores on a scale Interval 2.08 to 2.52

SECONDARY outcome

Timeframe: After first 2 weeks of treatment

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 physician, administered after the first 2 weeks of treatment 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	Placebo n=434 Participants Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks	Montelukast n=424 Participants Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks	Loratadine n=172 Participants Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
Physician's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment	2.75 Scores on a scale Interval 2.62 to 2.88	2.36 Scores on a scale Interval 2.23 to 2.5	2.38 Scores on a scale Interval 2.18 to 2.59

SECONDARY outcome

Timeframe: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)

Population: 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 through the first 2 weeks of treatment were included

Patients completed a Rhinoconjunctivitis Quality-of-Life Questionnaire-28 questions on a 7-point scale [0(best) to 6(worst)] across 7 domains: activity,sleep,non-nose/eye symptoms,practical problems,nasal symptoms, eye symptoms, and emotions. The scores for each domain were averaged, then scores for the 7 domains were averaged for an overall score.

Outcome measures

Measure	Placebo n=448 Participants Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks	Montelukast n=444 Participants Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks	Loratadine n=180 Participants Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After First 2 Weeks of Treatment Period	-0.55 Scores on a scale Interval -0.65 to -0.45	-0.85 Scores on a scale Interval -0.94 to -0.75	-0.85 Scores on a scale Interval -1.0 to -0.7

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Montelukast

Serious events: 2 serious events

Other events: 27 other events

Deaths: 0 deaths

Loratadine

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=451 participants at risk Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks	Montelukast n=448 participants at risk Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks	Loratadine n=180 participants at risk Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
Gastrointestinal disorders Appendicitis	0.00% 0/451 • During the 4 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 (AE) tables (448 montelukast group, 180 loratadine group and 451 in placebo group) is the number of patients who received study treatment. Although a patient may have had two or more clinical AEs the patient is counted only once in a category. The same patient may appear in different categories.	0.22% 1/448 • During the 4 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 (AE) tables (448 montelukast group, 180 loratadine group and 451 in placebo group) is the number of patients who received study treatment. Although a patient may have had two or more clinical AEs the patient is counted only once in a category. The same patient may appear in different categories.	0.00% 0/180 • During the 4 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 (AE) tables (448 montelukast group, 180 loratadine group and 451 in placebo group) is the number of patients who received study treatment. Although a patient may have had two or more clinical AEs the patient is counted only once in a category. The same patient may appear in different categories.
Pregnancy, puerperium and perinatal conditions Pregnancy	0.00% 0/451 • During the 4 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 (AE) tables (448 montelukast group, 180 loratadine group and 451 in placebo group) is the number of patients who received study treatment. Although a patient may have had two or more clinical AEs the patient is counted only once in a category. The same patient may appear in different categories.	0.22% 1/448 • During the 4 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 (AE) tables (448 montelukast group, 180 loratadine group and 451 in placebo group) is the number of patients who received study treatment. Although a patient may have had two or more clinical AEs the patient is counted only once in a category. The same patient may appear in different categories.	0.00% 0/180 • During the 4 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 (AE) tables (448 montelukast group, 180 loratadine group and 451 in placebo group) is the number of patients who received study treatment. Although a patient may have had two or more clinical AEs the patient is counted only once in a category. The same patient may appear in different categories.

Other adverse events

Measure	Placebo n=451 participants at risk Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks	Montelukast n=448 participants at risk Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks	Loratadine n=180 participants at risk Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
Nervous system disorders Headache	4.9% 22/451 • During the 4 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 (AE) tables (448 montelukast group, 180 loratadine group and 451 in placebo group) is the number of patients who received study treatment. Although a patient may have had two or more clinical AEs the patient is counted only once in a category. The same patient may appear in different categories.	6.0% 27/448 • During the 4 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 (AE) tables (448 montelukast group, 180 loratadine group and 451 in placebo group) is the number of patients who received study treatment. Although a patient may have had two or more clinical AEs the patient is counted only once in a category. The same patient may appear in different categories.	6.7% 12/180 • During the 4 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 (AE) tables (448 montelukast group, 180 loratadine group and 451 in placebo group) is the number of patients who received study treatment. Although a patient may have had two or more clinical AEs 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

Email: ClinicalTrialsDisclosure@merck.com

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