Rhinitis, Allergic, Perennial
Conditions
Brief summary
The purpose of this study is to determine the effect of an approved medication on the symptoms of perennial allergic rhinitis (an inflammation of the mucous membrane of the nose similar to that found in hay fever except that symptoms persist throughout the year), in patients who have a history of perennial allergic rhinitis.
Interventions
DRUGMontelukast
one 10 mg tablet, taken once daily at bed time for 6 weeks
DRUGComparator: Placebo
one placebo tablet, taken once daily at bed time 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
* Non-smoker with a 2-year documented history of perennial allergic (symptoms that persist throughout the year) rhinitis symptoms and positive allergy testing
Exclusion criteria
* Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Daytime Nasal Symptoms Score Averaged Over the 6-week Treatment Period in Patients With Perennial Allergic Rhinitis | 6 week treatment period (from baseline though the end of week 6) | Mean change from baseline in Daytime Nasal Symptoms score averaged over the 6-week treatment period. The Daytime Nasal Symptoms score was calculated as the average of the 3 individual scores for Congestion, Rhinorrhea, and Sneezing, each rated by patients daily on a 4-point scale \[Score 0 (best) to 3 (worst)\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient's Global Evaluation of Allergic Rhinitis at the End of the 6 Week Treatment Period | At the end of the 6 week treatment period | An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale \[Score 0 (best) to 6 (worst)\], in answer to a single question regarding the change in symptoms as compared to the beginning of the study. |
| Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score After the 6 Week Treatment Period | Baseline and Week 6 | Patients completed the validated, self-administered RQLQ which included 28 items on a 7-point scale \[Score 0 (best) to 6 (worst)\] across 7 domains: activities, sleep, nonnose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The scores for each domain were averaged, then scores for the 7 domains were averaged to obtain the overall score. |
Participant flow
Recruitment details
Patients were screened at 122 sites worldwide. Primary therapy period: Oct 2003 to May 2004
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 tablets were taken orally once daily at bedtime for 6 weeks. | 990 |
| Montelukast 10 mg Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks. | 1,002 |
| Total | 1,992 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 35 | 32 |
| Overall Study | Lack of Efficacy | 12 | 14 |
| Overall Study | Lost to Follow-up | 4 | 3 |
| Overall Study | Other | 6 | 5 |
| Overall Study | Protocol Violation | 23 | 25 |
| Overall Study | Withdrawal by Subject | 4 | 10 |
Baseline characteristics
| Characteristic | Montelukast 10 mg | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 36.3 years STANDARD_DEVIATION 13.61 | 36.4 years STANDARD_DEVIATION 13.36 | 36.6 years STANDARD_DEVIATION 13.12 |
| Daytime nasal symptoms score | 2.09 Scores on a scale STANDARD_DEVIATION 0.4 | 2.10 Scores on a scale STANDARD_DEVIATION 0.41 | 2.10 Scores on a scale STANDARD_DEVIATION 0.41 |
| Rhinoconjunctivitis Quality-of-Life Score | 2.94 Score on a scale STANDARD_DEVIATION 1.04 | 2.95 Score on a scale STANDARD_DEVIATION 1.07 | 2.96 Score on a scale STANDARD_DEVIATION 1.1 |
| Sex: Female, Male Female | 644 Participants | 1276 Participants | 632 Participants |
| Sex: Female, Male Male | 358 Participants | 716 Participants | 358 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 990 | 0 / 1,002 |
| serious Total, serious adverse events | 1 / 990 | 4 / 1,002 |
Outcome results
Primary
Mean Change From Baseline in Daytime Nasal Symptoms Score Averaged Over the 6-week Treatment Period in Patients With Perennial Allergic Rhinitis
Mean change from baseline in Daytime Nasal Symptoms score averaged over the 6-week treatment period. The Daytime Nasal Symptoms score was calculated as the average of the 3 individual scores for Congestion, Rhinorrhea, and Sneezing, each rated by patients daily on a 4-point scale \[Score 0 (best) to 3 (worst)\].
Time frame: 6 week treatment period (from baseline though the end of week 6)
Population: The primary efficacy analyses were performed using a modified intention-to-treat (MITT) approach. All patients with efficacy measurements, both at baseline and during the treatment period were included.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Mean Change From Baseline in Daytime Nasal Symptoms Score Averaged Over the 6-week Treatment Period in Patients With Perennial Allergic Rhinitis | -0.37 Score on a scale |
| Montelukast 10 mg | Mean Change From Baseline in Daytime Nasal Symptoms Score Averaged Over the 6-week Treatment Period in Patients With Perennial Allergic Rhinitis | -0.44 Score on a scale |
Secondary
Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score After the 6 Week Treatment Period
Patients completed the validated, self-administered RQLQ which included 28 items on a 7-point scale \[Score 0 (best) to 6 (worst)\] across 7 domains: activities, sleep, nonnose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The scores for each domain were averaged, then scores for the 7 domains were averaged to obtain the overall score.
Time frame: Baseline and Week 6
Population: The primary efficacy analyses were performed using a modified intention-to-treat (MITT) approach. Patients were excluded if no baseline or treatment period data were available
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score After the 6 Week Treatment Period | -0.69 Score on a scale |
| Montelukast 10 mg | Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score After the 6 Week Treatment Period | -0.84 Score on a scale |
Secondary
Patient's Global Evaluation of Allergic Rhinitis at the End of the 6 Week Treatment Period
An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale \[Score 0 (best) to 6 (worst)\], in answer to a single question regarding the change in symptoms as compared to the beginning of the study.
Time frame: At the end of the 6 week treatment period
Population: The analysis was performed using a modified intention-to-treat (MITT) approach. Patients were excluded if no treatment period data were available.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Patient's Global Evaluation of Allergic Rhinitis at the End of the 6 Week Treatment Period | 2.42 Score on a scale |
| Montelukast 10 mg | Patient's Global Evaluation of Allergic Rhinitis at the End of the 6 Week Treatment Period | 2.27 Score on a scale |