Trial Outcomes & Findings for Montelukast in Seasonal Allergic Rhinitis - Spring 2001 Study (0476-235) (NCT NCT00972738)

NCT ID: NCT00972738

Last Updated: 2022-02-03

Results Overview

Mean change from baseline in Daytime Nasal Symptoms. Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale \[Score 0 (best) to 3 (worst)\]. 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: 1214 participants
• Primary outcome timeframe: Baseline and over the 2-week treatment period
• Results posted on: 2022-02-03

Participant Flow

Thirty-two study sites in Canada and the United States. Primary Therapy Period: Apr-2001 to Jul-2001.

Patients who required certain medications as described in the protocol 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	Montelukast 10 mg Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.	Loratadine 10 mg Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.	Placebo Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
Overall Study STARTED	522	171	521
Overall Study COMPLETED	501	165	492
Overall Study NOT COMPLETED	21	6	29

Reasons for withdrawal

Measure	Montelukast 10 mg Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.	Loratadine 10 mg Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.	Placebo Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
Overall Study Adverse Event	7	1	8
Overall Study Protocol Violation	2	1	3
Overall Study Lost to Follow-up	1	0	1
Overall Study Lack of Efficacy	5	1	11
Overall Study Withdrawal by Subject	5	1	4
Overall Study Moved	0	0	1
Overall Study Other	1	2	1

Baseline Characteristics

Montelukast in Seasonal Allergic Rhinitis - Spring 2001 Study (0476-235)

Baseline characteristics by cohort

Measure	Montelukast 10 mg n=522 Participants Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.	Loratadine 10 mg n=171 Participants Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.	Placebo n=521 Participants Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.	Total n=1214 Participants Total of all reporting groups
Age, Continuous	35.5 years STANDARD_DEVIATION 13.93 • n=5 Participants	34.7 years STANDARD_DEVIATION 12.73 • n=7 Participants	35.8 years STANDARD_DEVIATION 12.61 • n=5 Participants	35.5 years STANDARD_DEVIATION 13.20 • n=4 Participants
Sex: Female, Male Female	326 Participants n=5 Participants	100 Participants n=7 Participants	338 Participants n=5 Participants	764 Participants n=4 Participants
Sex: Female, Male Male	196 Participants n=5 Participants	71 Participants n=7 Participants	183 Participants n=5 Participants	450 Participants n=4 Participants
Daytime Eye Symptoms score	1.49 Scores on a scale STANDARD_DEVIATION 0.77 • n=5 Participants	1.48 Scores on a scale STANDARD_DEVIATION 0.79 • n=7 Participants	1.53 Scores on a scale STANDARD_DEVIATION 0.81 • n=5 Participants	1.51 Scores on a scale STANDARD_DEVIATION 0.79 • n=4 Participants
Daytime Nasal Symptoms score	2.10 Scores on a scale STANDARD_DEVIATION 0.43 • n=5 Participants	2.15 Scores on a scale STANDARD_DEVIATION 0.45 • n=7 Participants	2.14 Scores on a scale STANDARD_DEVIATION 0.43 • n=5 Participants	2.12 Scores on a scale STANDARD_DEVIATION 0.43 • n=4 Participants
Nighttime Symptoms score	1.51 Scores on a scale STANDARD_DEVIATION 0.65 • n=5 Participants	1.49 Scores on a scale STANDARD_DEVIATION 0.64 • n=7 Participants	1.47 Scores on a scale STANDARD_DEVIATION 0.65 • n=5 Participants	1.49 Scores on a scale STANDARD_DEVIATION 0.65 • n=4 Participants
Rhinoconjunctivitis Quality-of-Life score	3.22 Scores on a scale STANDARD_DEVIATION 1.06 • n=5 Participants	3.24 Scores on a scale STANDARD_DEVIATION 0.97 • n=7 Participants	3.29 Scores on a scale STANDARD_DEVIATION 1.01 • n=5 Participants	3.25 Scores on a scale STANDARD_DEVIATION 1.03 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline and over the 2-week treatment period

Population: The primary efficacy analyses were based on 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. Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale [Score 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	Montelukast 10 mg n=519 Participants Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.	Loratadine 10 mg n=170 Participants Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.	Placebo n=521 Participants Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
Mean Change From Baseline in Daytime Nasal Symptoms Score Over the 2-week Treatment Period	-0.38 Scores on a scale Interval -0.43 to -0.33	-0.47 Scores on a scale Interval -0.55 to -0.39	-0.29 Scores on a scale Interval -0.33 to -0.24

SECONDARY outcome

Timeframe: Baseline and over the 2-week treatment period

Population: The primary efficacy analyses were based on 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 symptoms of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings daily on a 4-point [Scale 0 (best) to 3 (worst)]. The average of the individual symptoms scores was reported as the Nighttime Symptoms Score.

Outcome measures

Measure	Montelukast 10 mg n=519 Participants Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.	Loratadine 10 mg n=170 Participants Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.	Placebo n=521 Participants Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
Mean Change From Baseline in Nighttime Symptoms Score Over the 2-week Treatment Period	-0.28 Scores on a scale Interval -0.32 to -0.24	-0.28 Scores on a scale Interval -0.35 to -0.21	-0.20 Scores on a scale Interval -0.25 to -0.16

SECONDARY outcome

Timeframe: Baseline and over the 2-week treatment period

Population: The primary efficacy analyses were based on 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 symptoms 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	Montelukast 10 mg n=519 Participants Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.	Loratadine 10 mg n=170 Participants Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.	Placebo n=521 Participants Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
Mean Change From Baseline in Daytime Eye Symptoms Score Over the 2-week Treatment Period	-0.28 Scores on a scale Interval -0.32 to -0.23	-0.40 Scores on a scale Interval -0.47 to -0.32	-0.21 Scores on a scale Interval -0.25 to -0.16

SECONDARY outcome

Timeframe: End of the 2-week treatment period

Population: 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 [Score 0 (very much better) to 6 (very much worse)], of the change in symptoms as compared to the beginning of the study.

Outcome measures

Measure	Montelukast 10 mg n=519 Participants Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.	Loratadine 10 mg n=171 Participants Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.	Placebo n=517 Participants Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
Patient's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period	2.18 Scores on a scale Interval 2.05 to 2.31	2.19 Scores on a scale Interval 1.97 to 2.42	2.49 Scores on a scale Interval 2.36 to 2.62

SECONDARY outcome

Timeframe: End of the 2-week treatment period

Population: 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 [Score 0 (very much better) to 6 (very much worse)], of the change in symptoms as compared to the beginning of the study.

Outcome measures

Measure	Montelukast 10 mg n=521 Participants Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.	Loratadine 10 mg n=171 Participants Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.	Placebo n=515 Participants Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
Physician's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period	2.18 Scores on a scale Interval 2.07 to 2.3	2.16 Scores on a scale Interval 1.96 to 2.35	2.41 Scores on a scale Interval 2.29 to 2.52

SECONDARY outcome

Timeframe: Baseline and at the end of 2-week treatment period

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 a week 2 measurement were included. No missing values were imputed.

Patients completed a validated, self-administered Rhinoconjunctivitis Quality-of-Life 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 individual domain scores were calculated as the average values of all scores within a domain, then the scores for the 7 domains were averaged for the overall score.

Outcome measures

Measure	Montelukast 10 mg n=518 Participants Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.	Loratadine 10 mg n=171 Participants Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.	Placebo n=516 Participants Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After the 2-week Treatment Period	-0.90 Scores on a scale Interval -1.0 to -0.81	-0.98 Scores on a scale Interval -1.15 to -0.81	-0.66 Scores on a scale Interval -0.76 to -0.56

Adverse Events

Montelukast 10 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Loratadine 10 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

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