Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Seasonal
Conditions
Keywords
Allergic Rhinitis, Intermittent Allergic Rhinitis
Brief summary
This study will investigate the effectiveness of desloratadine in treating subjects with allergic rhinitis (AR) who meet the criteria for intermittent allergic rhinitis.
Interventions
DRUGPlacebo
Placebo tablet, once daily for 15 days
5-mg Desloratadine tablet, once daily for 15 days
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The subject must meet ALL of the criteria listed below for entry: * For this study, the diagnosis of IAR is not based solely on the current episode of AR. Subjects must have at least a 2 year history of AR consistent with IAR (defined as symptoms of allergic rhinitis present less than four days per week or for less than four consecutive weeks per year); the current episode can count as the second year. * Subjects must be 12 years of age and older, of either sex and of any race. * At the Run-In Visit, subjects must be sufficiently symptomatic, with a T5SS 12-hour AM-PRIOR (reflective) symptoms severity score of at least 6. * In order for a subject to qualify at the Baseline Visit, the sum of the daily averages of the diary recordings of the 12-hour AM PRIOR + PM-PRIOR (reflective) T5SS collected during Days -4 to -1 and the AM PRIOR T5SS on the morning of the Baseline Visit (Day 1) must be \>= 30. * Subjects must have a positive skin-prick test at screening to one or more allergens in the GA2LEN (or the usually used local) panel of seasonal and perennial allergens. Subjects must demonstrate an antigen-induced skin prick wheal at least 3 mm in diameter greater than diluent control. The positive tests must include the allergen(s) prevalent while this study is active. * Subjects must be free of any clinically significant disease, other than IAR, which would interfere with the study evaluations. * Subjects, or parents/legal guardians, must give written informed consent. Subjects must be able to adhere to dose and visit schedules and meet study requirements. * In females of childbearing potential, the urine pregnancy test (hCG) must be negative at the Screening Visit. * Nonsterile or premenopausal female subjects must be using a medically accepted method of birth control, that is, oral contraceptive, hormonal implant, medically prescribed intrauterine device (IUD), or depot injectable during the entire study. A female subject who is not currently sexually active must agree and consent to use one of the above-mentioned methods, if she becomes sexually active while participating in the study. A female subject who is not of childbearing potential must have a medical record of being surgically sterile (for example, hysterectomy and tubal ligation), or be at least 1 year postmenopausal.
Exclusion criteria
The subject will be excluded from entry if ANY of the criteria listed below are met: * Subjects with a history of anaphylaxis and/or severe local reaction(s) to skin testing with allergens. * Subjects with intolerable symptoms that would make participating in the study unbearable. * Subjects who have had an upper respiratory tract or sinus infection that required antibiotic therapy, and have not had at least a 14-day washout prior to the run-in period, or who have had a viral upper respiratory infection within 7 days prior to screening. * Subjects with asthma who require chronic use of inhaled or systemic corticosteroids. * Subjects with current or a history of frequent, clinically significant sinusitis or chronic purulent postnasal drip. * Subjects on immunotherapy (desensitization therapy) unless on a regular maintenance schedule prior to Visit 1 and staying on this schedule for the remainder of the study. * Subjects who, in the opinion of the investigator, are dependent on nasal, oral or ocular decongestants, nasal topical antihistamines or nasal steroids. * Subjects who have used any drug or device in an investigational protocol in the 30 days prior to Visit 1. * Female subjects who are pregnant or nursing. * Subjects with a history of hypersensitivity to the study drug or to their excipients or known to not tolerate any antihistamines. * Subject is a member of the Investigational Study Staff (currently involved with this study) or a member of the staff's family. * Subjects with current evidence of clinically significant hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric, autoimmune disease, or other diseases that preclude the subject's participation in the study. * Subjects whose ability to provide informed consent is compromised. * Subjects with a history of noncompliance with medications or treatment protocols. * Subjects with rhinitis medicamentosa. * Subjects who have, in the opinion of the investigator or designee, clinically significant nasal structural abnormalities, including large nasal polyps or marked septum deviation, that significantly interferes with nasal air flow. * Subjects who have not observed the medication washout times outlined in the protocol prior to Visit 2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Change From Baseline in the 12-hour AM/PM-PRIOR (Reflective) Total 5 Symptom Score (T5SS) From Subject Daily Diaries Averaged Over Treatment Days 1 to 15 | 15 days | AM/PM is the average of separate morning (AM) and evening (PM) evaluations. T5SS = the sum of the individual scores for nasal congestion/stuffiness, sneezing, rhinorrhea/nasal discharge, nasal pruritis, and ocular pruritis. Each individual symptom/sign was scored from 0 (none) to 3 (severe). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S) at the Final Visit | 15 days | The RQLQ-S questionnaire consists of 28 questions grouped into 7 domains. Each question is scored on a scale of 0 (not troubled with symptoms) to 6 (extremely troubled with symptoms). The total RQLQ-S score is the average score of the 28 questions which consisted of a total of 7 domains. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Total 5 Symptom Score (T5SS) - Average AM/PM PRIOR (Reflective) 12 Hours Diary: BASELINE | Baseline | AM/PM is the average of separate morning (AM) and evening (PM) evaluations. T5SS = the sum of the individual scores for nasal congestion/stuffiness, sneezing, rhinorrhea/nasal discharge, nasal pruritis, and ocular pruritis. Each individual symptom/sign was scored from 0 (none) to 3 (severe). |
| Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S: BASELINE | Baseline | The RQLQ-S questionnaire consists of 28 questions grouped into 7 domains. Each question is scored on a scale of 0 (not troubled with symptoms) to 6 (extremely troubled with symptoms). The total RQLQ-S score is the average score of the 28 questions which consisted of a total of 7 domains. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 5-mg Desloratadine Tablet 5 mg desloratadine tablet, once daily for 15 days | 276 |
| Placebo Tablet placebo tablet, once daily for 15 days | 271 |
| Total | 547 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 4 |
| Overall Study | Lost to Follow-up | 3 | 0 |
| Overall Study | Protocol Violation | 4 | 4 |
| Overall Study | Treatment Failure | 2 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 4 |
Baseline characteristics
| Characteristic | 5-mg Desloratadine Tablet | Placebo Tablet | Total |
|---|---|---|---|
| Age, Continuous | 33.8 years STANDARD_DEVIATION 12 | 34.6 years STANDARD_DEVIATION 12.8 | 34.2 years STANDARD_DEVIATION 12.4 |
| Sex: Female, Male Female | 154 Participants | 164 Participants | 318 Participants |
| Sex: Female, Male Male | 122 Participants | 107 Participants | 229 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 18 / 276 | 17 / 271 |
| serious Total, serious adverse events | 0 / 276 | 0 / 271 |
Outcome results
Primary
The Change From Baseline in the 12-hour AM/PM-PRIOR (Reflective) Total 5 Symptom Score (T5SS) From Subject Daily Diaries Averaged Over Treatment Days 1 to 15
AM/PM is the average of separate morning (AM) and evening (PM) evaluations. T5SS = the sum of the individual scores for nasal congestion/stuffiness, sneezing, rhinorrhea/nasal discharge, nasal pruritis, and ocular pruritis. Each individual symptom/sign was scored from 0 (none) to 3 (severe).
Time frame: 15 days
Population: Last Observation Carried Forward (LOCF) to the final visit. All randomized subjects with a non-missing baseline and at least some post-baseline data were included in the analyses.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 5-mg Desloratadine Tablet | The Change From Baseline in the 12-hour AM/PM-PRIOR (Reflective) Total 5 Symptom Score (T5SS) From Subject Daily Diaries Averaged Over Treatment Days 1 to 15 | -3.01 scores on a scale | Standard Error 0.21 |
| Placebo Tablet | The Change From Baseline in the 12-hour AM/PM-PRIOR (Reflective) Total 5 Symptom Score (T5SS) From Subject Daily Diaries Averaged Over Treatment Days 1 to 15 | -2.13 scores on a scale | Standard Error 0.2 |
p-value: <0.001ANOVA
Secondary
Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S) at the Final Visit
The RQLQ-S questionnaire consists of 28 questions grouped into 7 domains. Each question is scored on a scale of 0 (not troubled with symptoms) to 6 (extremely troubled with symptoms). The total RQLQ-S score is the average score of the 28 questions which consisted of a total of 7 domains.
Time frame: 15 days
Population: Last Observation Carried Forward (LOCF) to the final visit. The RQLQ-S was only completed for subjects \>=18 years of age and where available in the local language.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 5-mg Desloratadine Tablet | Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S) at the Final Visit | -1.1 scores on a scale | Standard Error 0.1 |
| Placebo Tablet | Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S) at the Final Visit | -0.73 scores on a scale | Standard Error 0.1 |
p-value: <0.001ANOVA
Other Pre-specified
Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S: BASELINE
The RQLQ-S questionnaire consists of 28 questions grouped into 7 domains. Each question is scored on a scale of 0 (not troubled with symptoms) to 6 (extremely troubled with symptoms). The total RQLQ-S score is the average score of the 28 questions which consisted of a total of 7 domains.
Time frame: Baseline
Population: Last Observation Carried Forward (LOCF) to the final visit. The RQLQ-S was only completed for subjects \>=18 years of age and where available in the local language.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 5-mg Desloratadine Tablet | Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S: BASELINE | 2.96 scores on a scale | Standard Error 0.08 |
| Placebo Tablet | Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S: BASELINE | 2.80 scores on a scale | Standard Error 0.08 |
Other Pre-specified
Total 5 Symptom Score (T5SS) - Average AM/PM PRIOR (Reflective) 12 Hours Diary: BASELINE
AM/PM is the average of separate morning (AM) and evening (PM) evaluations. T5SS = the sum of the individual scores for nasal congestion/stuffiness, sneezing, rhinorrhea/nasal discharge, nasal pruritis, and ocular pruritis. Each individual symptom/sign was scored from 0 (none) to 3 (severe).
Time frame: Baseline
Population: Last Observation Carried Forward (LOCF) to the final visit. All randomized subjects with a non-missing baseline and at least some post-baseline data were included in the analyses.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 5-mg Desloratadine Tablet | Total 5 Symptom Score (T5SS) - Average AM/PM PRIOR (Reflective) 12 Hours Diary: BASELINE | 8.5 scores on a scale | Standard Error 0.14 |
| Placebo Tablet | Total 5 Symptom Score (T5SS) - Average AM/PM PRIOR (Reflective) 12 Hours Diary: BASELINE | 8.33 scores on a scale | Standard Error 0.14 |