Perennial Allergic Rhinitis
Conditions
Brief summary
This study will assess the ability of montelukast to improve the signs and symptoms of perennial allergic rhinitis compared to placebo. Cetirizine is included in the study as an active control.
Interventions
DRUGmontelukast sodium
montelukast 10 mg tablet orally once daily at bedtime for 6 weeks
DRUGComparator: cetirizine
cetirizine 10 mg tablet orally once daily at bedtime for 6 weeks
DRUGComparator: placebo
placebo tablet orally once daily at bedtime for 6 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 perennial allergic rhinitis * 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 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 first 4 weeks of a 6-week 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 \[Score 0 (best) to 3 (worst)\]. 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 | Baseline and first 4 weeks in 6-week treatment period | Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptom daily on a 4-point scale \[Score 0 (best) to 3 (worst)\], and the average score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score. |
| Mean Change From Baseline in Composite Symptoms Score | Baseline and first 4 weeks in 6-week treatment period | Composite Symptoms Scores were computed as the average of the Daytime Nasal Symptoms Scores \[Score 0 (best) to 3 (worst)\]. and Nighttime Symptoms Scores collected \[Score 0 (best) to 3 (worst)\]. |
| Patient's Global Evaluation of Allergic Rhinitis | End of the first 4 weeks in 6-week treatment period | An evaluation by the patient, administered at week 4 of the study (or upon discontinuation) using a 7-point scale \[Score 0 (best) to 6 (worst)\], of the change in symptoms as compared to the beginning of the study. |
| Physician's Global Evaluation of Allergic Rhinitis | End of the first 4 weeks in 6-week treatment period | An evaluation by the physician, administered at week 4 of the study (or upon discontinuation) 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
74 study sites in the United States Primary Therapy: Nov-2001 to May-2002
Pre-assignment details
Patients who required excluded medication and those who did not meet a minimum predefined level of combined daytime rhinitis 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 cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks. | 630 |
| Cetirizine 10 mg Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks. | 122 |
| Placebo Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks. | 613 |
| Total | 1,365 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 31 | 4 | 27 |
| Overall Study | Lack of Efficacy | 3 | 2 | 9 |
| Overall Study | Lost to Follow-up | 2 | 1 | 2 |
| Overall Study | Other | 4 | 0 | 10 |
| Overall Study | Patient Moved | 1 | 0 | 1 |
| Overall Study | Protocol Violation | 13 | 4 | 18 |
| Overall Study | Withdrawal by Subject | 14 | 5 | 16 |
Baseline characteristics
| Characteristic | Montelukast 10 mg | Cetirizine 10 mg | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 35.3 years STANDARD_DEVIATION 12.87 | 36.3 years STANDARD_DEVIATION 13.67 | 35.3 years STANDARD_DEVIATION 13.17 | 35.4 years STANDARD_DEVIATION 13.07 |
| Composite Symptoms score | 1.86 Scores on a scale STANDARD_DEVIATION 0.44 | 1.89 Scores on a scale STANDARD_DEVIATION 0.43 | 1.82 Scores on a scale STANDARD_DEVIATION 0.45 | 1.85 Scores on a scale STANDARD_DEVIATION 0.44 |
| Daytime Nasal Symptoms score | 2.08 Scores on a scale STANDARD_DEVIATION 0.4 | 2.13 Scores on a scale STANDARD_DEVIATION 0.37 | 2.07 Scores on a scale STANDARD_DEVIATION 0.4 | 2.08 Scores on a scale STANDARD_DEVIATION 0.4 |
| Nighttime Symptoms score | 1.63 Scores on a scale STANDARD_DEVIATION 0.62 | 1.65 Scores on a scale STANDARD_DEVIATION 0.61 | 1.58 Scores on a scale STANDARD_DEVIATION 0.62 | 1.61 Scores on a scale STANDARD_DEVIATION 0.62 |
| Sex: Female, Male Female | 419 Participants | 85 Participants | 418 Participants | 922 Participants |
| Sex: Female, Male Male | 211 Participants | 37 Participants | 195 Participants | 443 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 | 85 / 630 | 16 / 122 | 65 / 613 |
| serious Total, serious adverse events | 2 / 630 | 0 / 122 | 3 / 613 |
Outcome results
Primary
Mean Change From Baseline in Daytime Nasal Symptoms Score
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 \[Score 0 (best) to 3 (worst)\]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score.
Time frame: Baseline and first 4 weeks of a 6-week treatment period
Population: 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 | -0.39 Scores on a scale |
| Cetirizine 10 mg | Mean Change From Baseline in Daytime Nasal Symptoms Score | -0.45 Scores on a scale |
| Placebo | Mean Change From Baseline in Daytime Nasal Symptoms Score | -0.36 Scores on a scale |
Secondary
Mean Change From Baseline in Composite Symptoms Score
Composite Symptoms Scores were computed as the average of the Daytime Nasal Symptoms Scores \[Score 0 (best) to 3 (worst)\]. and Nighttime Symptoms Scores collected \[Score 0 (best) to 3 (worst)\].
Time frame: Baseline and first 4 weeks in 6-week treatment period
Population: 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 Composite Symptoms Score | -0.34 Score 0 (best) to 3 (worst) |
| Cetirizine 10 mg | Mean Change From Baseline in Composite Symptoms Score | -0.38 Score 0 (best) to 3 (worst) |
| Placebo | Mean Change From Baseline in Composite Symptoms Score | -0.30 Score 0 (best) to 3 (worst) |
Secondary
Mean Change From Baseline in Nighttime Symptoms Score
Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptom daily on a 4-point scale \[Score 0 (best) to 3 (worst)\], and the average 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 4 weeks in 6-week treatment period
Population: 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 | -0.28 Scores on a scale |
| Cetirizine 10 mg | Mean Change From Baseline in Nighttime Symptoms Score | -0.30 Scores on a scale |
| Placebo | Mean Change From Baseline in Nighttime Symptoms Score | -0.26 Scores on a scale |
Secondary
Patient's Global Evaluation of Allergic Rhinitis
An evaluation by the patient, administered at week 4 of the study (or upon discontinuation) 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: End of the first 4 weeks in 6-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 | 2.22 Scores on a scale |
| Cetirizine 10 mg | Patient's Global Evaluation of Allergic Rhinitis | 2.15 Scores on a scale |
| Placebo | Patient's Global Evaluation of Allergic Rhinitis | 2.41 Scores on a scale |
Secondary
Physician's Global Evaluation of Allergic Rhinitis
An evaluation by the physician, administered at week 4 of the study (or upon discontinuation) 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: End of the first 4 weeks in 6-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 | 2.26 Scores on a scale |
| Cetirizine 10 mg | Physician's Global Evaluation of Allergic Rhinitis | 2.20 Scores on a scale |
| Placebo | Physician's Global Evaluation of Allergic Rhinitis | 2.33 Scores on a scale |