Seasonal Allergic Rhinitis
Conditions
Brief summary
This study will assess the treatment effect of montelukast versus placebo over a 2 week period in patients with seasonal allergic rhinitis. Loratadine is included in the study as an active comparator.
Interventions
DRUGmontelukast sodium
Montelukast 10-mg tablet orally once daily at bedtime for 2 weeks.
Loratadine 10-mg tablet orally once daily at bedtime for 2 weeks.
DRUGComparator: Placebo
placebo tablet orally once daily at bedtime for 2 weeks
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
15 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patient has a documented history of season allergic rhinitis symptoms that flare up during the study season * Patient is a nonsmoker * Patient is in good general health
Exclusion criteria
* Patient is hospitalized * Patient is a woman who is \<8 weeks postpartum or is breast-feeding * Patient has had major surgery in the past 4 weeks * Patient intends to move or vacation away during the study * Patient is a current or past abuser of alcohol or illicit drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Daytime Nasal Symptoms Score Over the 2-week Treatment Period | Baseline and over the 2-week treatment period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Nighttime Symptoms Score Over the 2-week Treatment Period | Baseline and over the 2-week treatment period | 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. |
| Mean Change From Baseline in Daytime Eye Symptoms Score Over the 2-week Treatment Period | Baseline and over the 2-week treatment period | 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. |
| Patient's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period | End of the 2-week treatment period | 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. |
| Physician's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period | End of the 2-week treatment period | 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. |
| Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After the 2-week Treatment Period | Baseline and at the end of 2-week treatment period | 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. |
Participant flow
Recruitment details
Thirty-two study sites in Canada and the United States. Primary Therapy Period: Apr-2001 to Jul-2001.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Montelukast 10 mg Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks. | 522 |
| Loratadine 10 mg Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks. | 171 |
| Placebo Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks. | 521 |
| Total | 1,214 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 7 | 1 | 8 |
| Overall Study | Lack of Efficacy | 5 | 1 | 11 |
| Overall Study | Lost to Follow-up | 1 | 0 | 1 |
| Overall Study | Moved | 0 | 0 | 1 |
| Overall Study | Other | 1 | 2 | 1 |
| Overall Study | Protocol Violation | 2 | 1 | 3 |
| Overall Study | Withdrawal by Subject | 5 | 1 | 4 |
Baseline characteristics
| Characteristic | Placebo | Total | Montelukast 10 mg | Loratadine 10 mg |
|---|---|---|---|---|
| Age, Continuous | 35.8 years STANDARD_DEVIATION 12.61 | 35.5 years STANDARD_DEVIATION 13.2 | 35.5 years STANDARD_DEVIATION 13.93 | 34.7 years STANDARD_DEVIATION 12.73 |
| Daytime Eye Symptoms score | 1.53 Scores on a scale STANDARD_DEVIATION 0.81 | 1.51 Scores on a scale STANDARD_DEVIATION 0.79 | 1.49 Scores on a scale STANDARD_DEVIATION 0.77 | 1.48 Scores on a scale STANDARD_DEVIATION 0.79 |
| Daytime Nasal Symptoms score | 2.14 Scores on a scale STANDARD_DEVIATION 0.43 | 2.12 Scores on a scale STANDARD_DEVIATION 0.43 | 2.10 Scores on a scale STANDARD_DEVIATION 0.43 | 2.15 Scores on a scale STANDARD_DEVIATION 0.45 |
| Nighttime Symptoms score | 1.47 Scores on a scale STANDARD_DEVIATION 0.65 | 1.49 Scores on a scale STANDARD_DEVIATION 0.65 | 1.51 Scores on a scale STANDARD_DEVIATION 0.65 | 1.49 Scores on a scale STANDARD_DEVIATION 0.64 |
| Rhinoconjunctivitis Quality-of-Life score | 3.29 Scores on a scale STANDARD_DEVIATION 1.01 | 3.25 Scores on a scale STANDARD_DEVIATION 1.03 | 3.22 Scores on a scale STANDARD_DEVIATION 1.06 | 3.24 Scores on a scale STANDARD_DEVIATION 0.97 |
| Sex: Female, Male Female | 338 Participants | 764 Participants | 326 Participants | 100 Participants |
| Sex: Female, Male Male | 183 Participants | 450 Participants | 196 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 522 | 0 / 171 | 0 / 521 |
| serious Total, serious adverse events | 0 / 522 | 0 / 171 | 0 / 521 |
Outcome results
Primary
Mean Change From Baseline in Daytime Nasal Symptoms Score Over the 2-week Treatment Period
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Montelukast 10 mg | Mean Change From Baseline in Daytime Nasal Symptoms Score Over the 2-week Treatment Period | -0.38 Scores on a scale |
| Loratadine 10 mg | Mean Change From Baseline in Daytime Nasal Symptoms Score Over the 2-week Treatment Period | -0.47 Scores on a scale |
| Placebo | Mean Change From Baseline in Daytime Nasal Symptoms Score Over the 2-week Treatment Period | -0.29 Scores on a scale |
Secondary
Mean Change From Baseline in Daytime Eye Symptoms Score Over the 2-week Treatment Period
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Montelukast 10 mg | Mean Change From Baseline in Daytime Eye Symptoms Score Over the 2-week Treatment Period | -0.28 Scores on a scale |
| Loratadine 10 mg | Mean Change From Baseline in Daytime Eye Symptoms Score Over the 2-week Treatment Period | -0.40 Scores on a scale |
| Placebo | Mean Change From Baseline in Daytime Eye Symptoms Score Over the 2-week Treatment Period | -0.21 Scores on a scale |
Secondary
Mean Change From Baseline in Nighttime Symptoms Score Over the 2-week Treatment Period
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Montelukast 10 mg | Mean Change From Baseline in Nighttime Symptoms Score Over the 2-week Treatment Period | -0.28 Scores on a scale |
| Loratadine 10 mg | Mean Change From Baseline in Nighttime Symptoms Score Over the 2-week Treatment Period | -0.28 Scores on a scale |
| Placebo | Mean Change From Baseline in Nighttime Symptoms Score Over the 2-week Treatment Period | -0.20 Scores on a scale |
Secondary
Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After the 2-week Treatment Period
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Montelukast 10 mg | Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After the 2-week Treatment Period | -0.90 Scores on a scale |
| Loratadine 10 mg | Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After the 2-week Treatment Period | -0.98 Scores on a scale |
| Placebo | Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After the 2-week Treatment Period | -0.66 Scores on a scale |
Secondary
Patient's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Montelukast 10 mg | Patient's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period | 2.18 Scores on a scale |
| Loratadine 10 mg | Patient's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period | 2.19 Scores on a scale |
| Placebo | Patient's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period | 2.49 Scores on a scale |
Secondary
Physician's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Montelukast 10 mg | Physician's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period | 2.18 Scores on a scale |
| Loratadine 10 mg | Physician's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period | 2.16 Scores on a scale |
| Placebo | Physician's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period | 2.41 Scores on a scale |