Seasonal Allergic Rhinitis
Conditions
Brief summary
This study will evaluate the ability of montelukast to improve the signs and symptoms of seasonal allergic rhinitis compared with loratadine and placebo.
Interventions
10 mg montelukast tablet given once daily at bedtime for 2 weeks
10 mg loratadine tablet given once daily at bedtime for 2 weeks
DRUGComparator: placebo
placebo tablet given once daily at bedtime for 2 weeks
montelukast 10-mg/loratadine 10-mg combination tablet taken 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 seasonal allergic rhinitis symptoms that flare up during the study season * Patient is a nonsmoker and has been a nonsmoker for at least 1 year * Patient is in good general health
Exclusion criteria
* Patient is hospitalized * Patient is a woman who is less than 8 weeks postpartum or is breast-feeding * Patient intends to move or vacation away during the study * Patient has had any major surgery within 4 weeks of study start * Patient is a current or past abuser of alcohol or illicit drugs * Patient has been treated in an emergency room for asthma in the past month * Patient had an upper respiratory infection with in 3 weeks prior to study start
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Daytime Nasal Symptoms Score Over 2 Weeks | Baseline and Week 2 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Nighttime Symptoms Score Over 2 Weeks | Baseline and Week 2 | 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). |
| Mean Change From Baseline in Daytime Eye Symptoms Score Over 2 Weeks | Baseline and Week 2 | 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). |
| Patient's Global Evaluation of Allergic Rhinitis at Week 2 | Week 2 | 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). |
| Physician's Global Evaluation of Allergic Rhinitis at Week 2 | Week 2 | 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). |
| Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score at Week 2 | Week 2 | 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). |
Participant flow
Recruitment details
Patients were recruited at 50 sites (43 in the US and 7 in Canada). Primary Therapy Period: March 2000 to July 2000.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks. | 352 |
| 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. | 348 |
| 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. | 602 |
| 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. | 275 |
| Total | 1,577 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 3 | 9 | 2 |
| Overall Study | Discontinued in Error | 0 | 1 | 0 | 0 |
| Overall Study | elevated lab values pre-randomization | 1 | 0 | 0 | 0 |
| Overall Study | Lack of Efficacy | 8 | 4 | 9 | 0 |
| Overall Study | Left Country | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 | 2 | 0 |
| Overall Study | Noncompliance | 1 | 0 | 0 | 0 |
| Overall Study | out-of-state | 1 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 2 | 2 | 7 | 1 |
| Overall Study | Treatment Group Terminated by Sponsor | 0 | 0 | 0 | 112 |
| Overall Study | vacation | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Placebo | Montelukast 10 mg | Loratadine 10 mg | Montelukast/Loratadine | Total |
|---|---|---|---|---|---|
| Age, Continuous | 35.9 Years STANDARD_DEVIATION 12.4 | 36.5 Years STANDARD_DEVIATION 12.6 | 36.3 Years STANDARD_DEVIATION 13 | 37.1 Years STANDARD_DEVIATION 11.95 | 36.39 Years STANDARD_DEVIATION 12.61 |
| Daytime eye symptoms score | 1.44 Units on a Scale STANDARD_DEVIATION 0.78 | 1.39 Units on a Scale STANDARD_DEVIATION 0.77 | 1.40 Units on a Scale STANDARD_DEVIATION 0.76 | 0 Units on a Scale STANDARD_DEVIATION 0 | 1.41 Units on a Scale STANDARD_DEVIATION 0.77 |
| Daytime nasal symptoms score | 2.10 Units on a Scale STANDARD_DEVIATION 0.43 | 2.09 Units on a Scale STANDARD_DEVIATION 0.44 | 2.06 Units on a Scale STANDARD_DEVIATION 0.41 | 0 Units on a Scale STANDARD_DEVIATION 0 | 2.08 Units on a Scale STANDARD_DEVIATION 0.43 |
| Nighttime symptoms score | 1.46 Units on a Scale STANDARD_DEVIATION 0.66 | 1.43 Units on a Scale STANDARD_DEVIATION 0.64 | 1.45 Units on a Scale STANDARD_DEVIATION 0.64 | 0 Units on a Scale STANDARD_DEVIATION 0 | 1.45 Units on a Scale STANDARD_DEVIATION 0.65 |
| Rhinoconjunctivitis quality-of-life questionnaire (RQLQ) overall score | 3.22 Units on a Scale STANDARD_DEVIATION 0.99 | 3.12 Units on a Scale STANDARD_DEVIATION 0.99 | 3.09 Units on a Scale STANDARD_DEVIATION 1.03 | 0 Units on a Scale STANDARD_DEVIATION 0 | 3.13 Units on a Scale STANDARD_DEVIATION 1.01 |
| Sex: Female, Male Female | 229 Participants | 233 Participants | 390 Participants | 184 Participants | 1036 Participants |
| Sex: Female, Male Male | 123 Participants | 115 Participants | 212 Participants | 91 Participants | 541 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 352 | 0 / 348 | 0 / 602 | 0 / 275 |
| serious Total, serious adverse events | 1 / 352 | 0 / 348 | 0 / 602 | 0 / 275 |
Outcome results
Primary
Mean Change From Baseline in Daytime Nasal Symptoms Score Over 2 Weeks
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).
Time frame: Baseline and Week 2
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Mean Change From Baseline in Daytime Nasal Symptoms Score Over 2 Weeks | -0.24 Units on a Scale |
| Montelukast 10 mg | Mean Change From Baseline in Daytime Nasal Symptoms Score Over 2 Weeks | -0.37 Units on a Scale |
| Loratadine 10 mg | Mean Change From Baseline in Daytime Nasal Symptoms Score Over 2 Weeks | -0.47 Units on a Scale |
Secondary
Mean Change From Baseline in Daytime Eye Symptoms Score Over 2 Weeks
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).
Time frame: Baseline and Week 2
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Mean Change From Baseline in Daytime Eye Symptoms Score Over 2 Weeks | -0.12 Units on a Scale |
| Montelukast 10 mg | Mean Change From Baseline in Daytime Eye Symptoms Score Over 2 Weeks | -0.26 Units on a Scale |
| Loratadine 10 mg | Mean Change From Baseline in Daytime Eye Symptoms Score Over 2 Weeks | -0.32 Units on a Scale |
Secondary
Mean Change From Baseline in Nighttime Symptoms Score Over 2 Weeks
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).
Time frame: Baseline and Week 2
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Mean Change From Baseline in Nighttime Symptoms Score Over 2 Weeks | -0.14 Units on a Scale |
| Montelukast 10 mg | Mean Change From Baseline in Nighttime Symptoms Score Over 2 Weeks | -0.27 Units on a Scale |
| Loratadine 10 mg | Mean Change From Baseline in Nighttime Symptoms Score Over 2 Weeks | -0.23 Units on a Scale |
Secondary
Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score at Week 2
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).
Time frame: Week 2
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score at Week 2 | -0.65 Units on a Scale |
| Montelukast 10 mg | Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score at Week 2 | -0.89 Units on a Scale |
| Loratadine 10 mg | Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score at Week 2 | -0.99 Units on a Scale |
Secondary
Patient's Global Evaluation of Allergic Rhinitis at Week 2
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).
Time frame: Week 2
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Patient's Global Evaluation of Allergic Rhinitis at Week 2 | 2.62 Units on a Scale |
| Montelukast 10 mg | Patient's Global Evaluation of Allergic Rhinitis at Week 2 | 2.20 Units on a Scale |
| Loratadine 10 mg | Patient's Global Evaluation of Allergic Rhinitis at Week 2 | 2.13 Units on a Scale |
Secondary
Physician's Global Evaluation of Allergic Rhinitis at Week 2
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).
Time frame: Week 2
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Physician's Global Evaluation of Allergic Rhinitis at Week 2 | 2.53 Units on a Scale |
| Montelukast 10 mg | Physician's Global Evaluation of Allergic Rhinitis at Week 2 | 2.23 Units on a Scale |
| Loratadine 10 mg | Physician's Global Evaluation of Allergic Rhinitis at Week 2 | 2.17 Units on a Scale |