Seasonal Allergic Rhinitis
Conditions
Brief summary
This is a study to evaluate the treatment effect of montelukast 10 mg taken in the morning, versus placebo, in patients with seasonal allergic rhinitis. Loratadine is included in the study as an active control.
Interventions
DRUGmontelukast sodium
montelukast 10 mg tablet orally once daily in the morning for 4 weeks
loratadine 10 mg tablet orally once daily in the morning for 4 weeks
DRUGComparator: placebo
placebo tablet orally once daily in the morning for 4 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 history of seasonal allergic rhinitis that worsens during the study season * Patient is a nonsmoker * Patient is in good health physical and mental health
Exclusion criteria
* Patient is hospitalized * Patient is a woman who is \< 8 weeks postpartum or is breastfeeding * Patient plans to move or vacation away during the study * Patient has had any major surgery with in past 4 weeks * 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 First 2 Weeks of Treatment Period | Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) Over First 2 Weeks of Treatment Period | Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2) | Composite Symptoms Scores were computed as the average of Daytime Nasal Scores \[Score 0 (best) to 3 (worst)\] and Nighttime Symptoms Scores \[Score 0 (best) to 3 (worst)\]. |
| Mean Change From Baseline in Daytime Eye Symptoms Score Over First 2 Weeks of Treatment Period | Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2) | 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. |
| Mean Change From Baseline in Nighttime Symptoms Score Over First 2 Weeks of Treatment Period | Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2) | 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. |
| Physician's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment | After first 2 weeks of treatment | 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. |
| Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After First 2 Weeks of Treatment Period | Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2) | 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. |
| Patient's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment | After first 2 weeks of treatment | 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. |
Participant flow
Recruitment details
Forty-seven study centers in the United States. Prime Therapy Period: August 2001 to November 2001
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 Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks | 451 |
| Montelukast Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks | 448 |
| Loratadine Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks | 180 |
| Total | 1,079 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 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 | Moved | 1 | 0 | 0 |
| Overall Study | Pre-randomization Adverse Event | 1 | 2 | 0 |
| Overall Study | Protocol Violation | 5 | 5 | 3 |
| Overall Study | Site closed (local pollen Season ended) | 4 | 1 | 3 |
| Overall Study | Withdrawal by Subject | 4 | 1 | 1 |
Baseline characteristics
| Characteristic | Placebo | Montelukast | Loratadine | Total |
|---|---|---|---|---|
| Age, Continuous | 35.9 years | 35.5 years | 38.7 years | 36.2 years |
| Composite Symptoms Score | 1.94 Scores on a scale STANDARD_DEVIATION 0.46 | 1.98 Scores on a scale STANDARD_DEVIATION 0.47 | 2.03 Scores on a scale STANDARD_DEVIATION 0.46 | 1.97 Scores on a scale STANDARD_DEVIATION 0.46 |
| Daytime Eye Symptoms score | 1.61 Scores on a scale STANDARD_DEVIATION 0.81 | 1.64 Scores on a scale STANDARD_DEVIATION 0.73 | 1.64 Scores on a scale STANDARD_DEVIATION 0.78 | 1.63 Scores on a scale STANDARD_DEVIATION 0.77 |
| Daytime Nasal Symptoms Score | 2.16 Scores on a scale STANDARD_DEVIATION 0.44 | 2.20 Scores on a scale STANDARD_DEVIATION 0.46 | 2.23 Scores on a scale STANDARD_DEVIATION 0.44 | 2.19 Scores on a scale STANDARD_DEVIATION 0.45 |
| Nighttime Symptoms Score | 1.65 Scores on a scale STANDARD_DEVIATION 0.64 | 1.69 Scores on a scale STANDARD_DEVIATION 0.64 | 1.77 Scores on a scale STANDARD_DEVIATION 0.63 | 1.69 Scores on a scale STANDARD_DEVIATION 0.64 |
| Rhinoconjunctivitis Quality of Life Score | 3.37 Scores on a scale STANDARD_DEVIATION 1.02 | 3.41 Scores on a scale STANDARD_DEVIATION 1 | 3.46 Scores on a scale STANDARD_DEVIATION 1.08 | 3.40 Scores on a scale STANDARD_DEVIATION 1.02 |
| Sex: Female, Male Female | 301 Participants | 301 Participants | 119 Participants | 721 Participants |
| Sex: Female, Male Male | 150 Participants | 147 Participants | 61 Participants | 358 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 | 22 / 451 | 27 / 448 | 12 / 180 |
| serious Total, serious adverse events | 0 / 451 | 2 / 448 | 0 / 180 |
Outcome results
Primary
Mean Change From Baseline in Daytime Nasal Symptoms Score Over First 2 Weeks of Treatment Period
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Mean Change From Baseline in Daytime Nasal Symptoms Score Over First 2 Weeks of Treatment Period | -0.23 Scores on a scale |
| Montelukast | Mean Change From Baseline in Daytime Nasal Symptoms Score Over First 2 Weeks of Treatment Period | -0.33 Scores on a scale |
| Loratadine | Mean Change From Baseline in Daytime Nasal Symptoms Score Over First 2 Weeks of Treatment Period | -0.45 Scores on a scale |
Secondary
Mean Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) Over First 2 Weeks of Treatment Period
Composite Symptoms Scores were computed as the average of Daytime Nasal Scores \[Score 0 (best) to 3 (worst)\] and Nighttime Symptoms Scores \[Score 0 (best) to 3 (worst)\].
Time frame: 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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | 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 |
| Montelukast | Mean Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) Over First 2 Weeks of Treatment Period | -0.30 Scores on a scale |
| Loratadine | Mean Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) Over First 2 Weeks of Treatment Period | -0.36 Scores on a scale |
Secondary
Mean Change From Baseline in Daytime Eye Symptoms Score Over First 2 Weeks of Treatment Period
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.
Time frame: 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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Mean Change From Baseline in Daytime Eye Symptoms Score Over First 2 Weeks of Treatment Period | -0.18 Scores on a scale |
| Montelukast | Mean Change From Baseline in Daytime Eye Symptoms Score Over First 2 Weeks of Treatment Period | -0.28 Scores on a scale |
| Loratadine | Mean Change From Baseline in Daytime Eye Symptoms Score Over First 2 Weeks of Treatment Period | -0.33 Scores on a scale |
Secondary
Mean Change From Baseline in Nighttime Symptoms Score Over First 2 Weeks of Treatment Period
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.
Time frame: 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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Mean Change From Baseline in Nighttime Symptoms Score Over First 2 Weeks of Treatment Period | -0.18 Scores on a scale |
| Montelukast | Mean Change From Baseline in Nighttime Symptoms Score Over First 2 Weeks of Treatment Period | -0.28 Scores on a scale |
| Loratadine | Mean Change From Baseline in Nighttime Symptoms Score Over First 2 Weeks of Treatment Period | -0.25 Scores on a scale |
Secondary
Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After First 2 Weeks of Treatment Period
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.
Time frame: 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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After First 2 Weeks of Treatment Period | -0.55 Scores on a scale |
| Montelukast | Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After First 2 Weeks of Treatment Period | -0.85 Scores on a scale |
| Loratadine | Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After First 2 Weeks of Treatment Period | -0.85 Scores on a scale |
Secondary
Patient's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Patient's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment | 2.73 Scores on a scale |
| Montelukast | Patient's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment | 2.43 Scores on a scale |
| Loratadine | Patient's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment | 2.30 Scores on a scale |
Secondary
Physician's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Physician's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment | 2.75 Scores on a scale |
| Montelukast | Physician's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment | 2.36 Scores on a scale |
| Loratadine | Physician's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment | 2.38 Scores on a scale |