Seasonal Allergic Rhinitis
Conditions
Brief summary
A study of the ability of montelukast to improve signs and symptoms of seasonal allergic rhinitis compared with placebo. Loratadine is included in the study as an active control.
Interventions
DRUGmontelukast sodium
montelukast 10 mg tablet, taken orally once daily at bed time for 2 weeks
loratadine 10 mg tablet, taken orally once daily at bed time for 2 weeks
DRUGComparator: placebo
placebo tablet, taken orally once daily at bed time 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 clinical history of seasonal allergic rhinitis symptoms that become worse during the study season * Patient is a non-smoker * Patient is in good mental and physical health
Exclusion criteria
* Patient is hospitalized * Patient is a woman who is \<8 weeks postpartum or is breast feeding * 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 | Baseline and Week 2 | Mean change from baseline in Daytime Nasal Symptoms score on a 4-point scale \[0(best) to 3(worst)\]. The average of the 4 individual nasal symptoms scores (Congestion, Rhinorrhea, Itching, and Sneezing) was reported as the Daytime Nasal Symptoms Score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Nighttime Symptoms Score | Baseline and Week 2 | Mean change from baseline in Nighttime Symptoms Score on a 4-point scale \[0(best) to 3(worst)\]. The average of 3 scores (Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings) was reported as the Nighttime Symptoms Score. |
| Mean Change From Baseline in Daytime Eye Symptoms Score | Baseline and Week 2 | Mean change from baseline in Daytime Eye Symptoms scores on a 4-point scale \[0(best) to 3(worst)\]. The average of the 4 individual eye symptoms scores (tearing, itchy, red, and puffy eyes) was reported as the Daytime Eye Symptoms Score. |
| Patient's Global Evaluation of Allergic Rhinitis | Week 2 (or upon discontinuation) | An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale, in answer to a single question regarding the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse). |
| Physician's Global Evaluation of Allergic Rhinitis | 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. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse). |
| Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score | Baseline and Week 2 | Patients completed a validated, self-administered 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 scores for each domain were averaged, then the scores for the 7 domains were averaged for the overall score. |
Participant flow
Recruitment details
Twenty-nine study centers in the United States. Therapy Period: August 2000 to October 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 Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks | 333 |
| Montelukast Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks. | 326 |
| Loratadine Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks. | 170 |
| Total | 829 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 4 | 8 | 2 |
| Overall Study | Lack of Efficacy | 3 | 4 | 2 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 1 | 3 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 1 |
Baseline characteristics
| Characteristic | Placebo | Montelukast | Loratadine | Total |
|---|---|---|---|---|
| Age, Continuous | 36.4 years | 36.3 years | 37.5 years | 36.6 years |
| Daytime Eye Symptoms score | 1.46 Units on a Scale STANDARD_DEVIATION 0.78 | 1.46 Units on a Scale STANDARD_DEVIATION 0.76 | 1.44 Units on a Scale STANDARD_DEVIATION 0.8 | 1.46 Units on a Scale STANDARD_DEVIATION 0.77 |
| Daytime Nasal Symptoms Score | 2.09 Units on a Scale STANDARD_DEVIATION 0.44 | 2.14 Units on a Scale STANDARD_DEVIATION 0.43 | 2.08 Units on a Scale STANDARD_DEVIATION 0.4 | 2.11 Units on a Scale STANDARD_DEVIATION 0.43 |
| Nighttime Symptoms Score | 1.53 Units on a Scale STANDARD_DEVIATION 0.62 | 1.49 Units on a Scale STANDARD_DEVIATION 0.6 | 1.54 Units on a Scale STANDARD_DEVIATION 0.68 | 1.52 Units on a Scale STANDARD_DEVIATION 0.62 |
| Rhinoconjunctivitis Quality-of-Life score | 3.18 Units on a Scale STANDARD_DEVIATION 1 | 3.20 Units on a Scale STANDARD_DEVIATION 1 | 3.26 Units on a Scale STANDARD_DEVIATION 1.08 | 3.20 Units on a Scale STANDARD_DEVIATION 1.02 |
| Sex: Female, Male Female | 222 Participants | 227 Participants | 119 Participants | 568 Participants |
| Sex: Female, Male Male | 111 Participants | 99 Participants | 51 Participants | 261 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 | 19 / 333 | 13 / 326 | 8 / 170 |
| serious Total, serious adverse events | 0 / 333 | 1 / 326 | 0 / 170 |
Outcome results
Primary
Mean Change From Baseline in Daytime Nasal Symptoms Score
Mean change from baseline in Daytime Nasal Symptoms score on a 4-point scale \[0(best) to 3(worst)\]. The average of the 4 individual nasal symptoms scores (Congestion, Rhinorrhea, Itching, and Sneezing) was reported as the Daytime Nasal Symptoms Score.
Time frame: Baseline and 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 were included.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Mean Change From Baseline in Daytime Nasal Symptoms Score | -0.32 Units on a Scale |
| Montelukast | Mean Change From Baseline in Daytime Nasal Symptoms Score | -0.38 Units on a Scale |
| Loratadine | Mean Change From Baseline in Daytime Nasal Symptoms Score | -0.47 Units on a Scale |
Secondary
Mean Change From Baseline in Daytime Eye Symptoms Score
Mean change from baseline in Daytime Eye Symptoms scores on a 4-point scale \[0(best) to 3(worst)\]. The average of the 4 individual eye symptoms scores (tearing, itchy, red, and puffy eyes) was reported as the Daytime Eye Symptoms Score.
Time frame: Baseline and 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 were included.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Mean Change From Baseline in Daytime Eye Symptoms Score | -0.23 Units on a Scale |
| Montelukast | Mean Change From Baseline in Daytime Eye Symptoms Score | -0.29 Units on a Scale |
| Loratadine | Mean Change From Baseline in Daytime Eye Symptoms Score | -0.35 Units on a Scale |
Secondary
Mean Change From Baseline in Nighttime Symptoms Score
Mean change from baseline in Nighttime Symptoms Score on a 4-point scale \[0(best) to 3(worst)\]. The average of 3 scores (Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings) was reported as the Nighttime Symptoms Score.
Time frame: Baseline and 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 were included.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Mean Change From Baseline in Nighttime Symptoms Score | -0.18 Units on a Scale |
| Montelukast | Mean Change From Baseline in Nighttime Symptoms Score | -0.28 Units on a Scale |
| Loratadine | Mean Change From Baseline in Nighttime Symptoms Score | -0.26 Units on a Scale |
Secondary
Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score
Patients completed a validated, self-administered 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 scores for each domain were averaged, then the scores for the 7 domains were averaged for the overall score.
Time frame: Baseline and 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 were included. No missing values were imputed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score | -0.75 Units on a Scale |
| Montelukast | Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score | -0.85 Units on a Scale |
| Loratadine | Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score | -0.97 Units on a Scale |
Secondary
Patient's Global Evaluation of Allergic Rhinitis
An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale, in answer to a single question regarding the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).
Time frame: Week 2 (or upon discontinuation)
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 | 2.62 Units on a Scale |
| Montelukast | Patient's Global Evaluation of Allergic Rhinitis | 2.43 Units on a Scale |
| Loratadine | Patient's Global Evaluation of Allergic Rhinitis | 2.27 Units on a Scale |
Secondary
Physician's Global Evaluation of Allergic Rhinitis
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. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).
Time frame: Week 2
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 | 2.53 Units on a Scale |
| Montelukast | Physician's Global Evaluation of Allergic Rhinitis | 2.35 Units on a Scale |
| Loratadine | Physician's Global Evaluation of Allergic Rhinitis | 2.26 Units on a Scale |