Perennial Allergic Rhinitis
Conditions
Keywords
Rhinitis, Allergic Rhinitis, Nose Diseases, Respiratory Tract Diseases, Immune System Diseases, Cholinergic Antagonists, Cholinergic Agents, Neurotransmitter Agents, Histamine H1 Antagonists, Non-Sedating, Histamine H1 Antagonists, Histamine Antagonists, Histamine Agents
Brief summary
This is a study to evaluate the efficacy and safety of desloratadine (MK-4117) in Japanese participants with perennial allergic rhinitis. The primary hypothesis is that desloratadine is superior to placebo after 2 weeks of treatment with regard to change from baseline in Total Nasal Symptom Score among Japanese participants with perennial allergic rhinitis.
Interventions
Desloratadine 5 mg tablets
DRUGPlacebo
Matching placebo to desloratadine 5 mg tablets
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
* Diagnosed with perennial allergic rhinitis * Outpatient.
Exclusion criteria
* Lower respiratory tract infection or nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, etc.) * Coexisting infections or systemic mycosis for which there are no effective antibiotics * Asthma complication under treatment * Nasal septum ulcers, nasal surgery, or nasal trauma, which has not healed * Vasomotor rhinitis or eosinophilic rhinitis * Nasal conditions (infectious sinusitis, hypertrophic rhinitis, acute or chronic rhinitis, nasal polyps, septal deviation, etc.) which may interfere with the evaluation of the efficacy of the study drug * History of hypersensitivity to antihistamines or study drug * Currently receiving treatment with another investigational drug or has received an investigational drug in the past 3 months * Has started specific desensitization therapy or nonspecific allassotherapy (Histaglobin, vaccine therapy, etc.) or who had discontinued such therapies within 90 days (3 months) before the day of obtaining informed consent * Severe hepatic, renal, cardiac, hematological disease, or other serious coexisting diseases and whose general condition is poor * History of malignancy or clinically important hematological disorder * History of severe drug allergy (e.g., anaphylactoid reaction).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Week 2 | Baseline and Week 2 | The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). The TNSS is the sum of the 4 nasal symptom sub-scores. TNSS scores could range from 0 to 12, with a higher score indicating more frequent/severe nasal symptoms. |
| Number of Participants Experiencing an Adverse Event (AE) | Up to Week 4 | An AE is defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of the study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE. The number of participants who experienced an AE, regardless of causality or severity, was summarized. |
| Number of Participants Discontinuing Study Drug Due to an AE | Up to Week 2 | An AE is defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of the study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE. The number of participants who discontinued study drug, whether permanently or temporarily, due to an AE was summarized. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Eye Symptom Score Assessed by the Investigator | Baseline and Day 3, Week 1, Week 2 | The investigator interviewed and examined participants for eye (itching) symptoms (score of 0=none to 3=eye is itchy, requiring frequent rubbing of eye). Eye symptom scores could range from 0 to 3, with a higher score indicating greater eye itchiness. |
| Number of Participants With Moderate-to-Remarkable Improvement in Global Improvement Assessed by the Investigator | Day 3, Week 1, Week 2 | The investigator comprehensively evaluated participants on global improvement according to 5 grades: 1=remarkably improved, 2= moderately improved, 3=slightly improved, 4=unchanged, and 5=aggravated. The number of participants who were evaluated as remarkably improved and moderately improved was calculated. |
| Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Day 3 and Week 1 | Baseline and Day 3, Week 1 | The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). The TNSS is the sum of the 4 nasal symptom sub-scores. TNSS scores could range from 0 to 12, with a higher score indicating more frequent/severe nasal symptoms. |
| Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Baseline and Day 3, Week 1, Week 2 | Participants evaluated themselves in their daily allergy diaries for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). Each nasal symptom sub-score could range from 0 to 3, with a higher sub-score indicating more frequent/severe nasal symptoms. |
| Change From Baseline in Eye Symptom Score Reported in Participant Diaries | Baseline and Day 3, Week 1, Week 2 | Participants evaluated themselves in their daily allergy diaries for eye (itching) symptoms (score of 0=none to 3=eye is itchy, requiring frequent rubbing of eye). Eye symptom scores could range from 0 to 3, with a higher score indicating greater eye itchiness. |
| Change From Baseline in Score on Interference With Daily Activities Assessed by the Investigator | Baseline and Day 3, Week 1, Week 2 | The investigator interviewed participants at Baseline, Day 3, Week 1 and Week 2 to evaluate interference with daily activities according to the following scale: 0=none, 1=nasal symptom interferes with daily activities from time to time (+), 2=between 1 and 3 (++), and 3=nasal symtom interferes with daily activity often (+++). Interference with daily activities scores could range from 0 to 3, with a higher score indicating greater interference with daily activities. |
| Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Baseline and Day 3, Week 1, Week 2 | The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attackes; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores could range from 0 to 3, with a higher nasal symptom sub-score indicating more frequent/severe nasal symptoms. |
| Change From Baseline in Nasal Finding Score Assessed by the Investigator | Baseline and Day 3, Week 1, Week 2 | The investigator conducted rhinoscopic examinations on participants to evaluate: swelling of inferior nasal concha mucosa (INCM) (score of 0=none to 3=middle nasal concha is not visible), coloring of inferior nasal concha mucosa (INCM) (score of 0=normal to 3=pale), and nasal discharge production (NDP) (score of 0=none to 3=congesting). The score for each nasal finding component could range from 0 to 3, with a higher score indicating more severe symptoms. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Desloratadine 5 mg Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks | 203 |
| Desloratadine 10 mg Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks | 203 |
| Placebo Participants receive two placebo tablets orally once daily for up to 2 weeks | 202 |
| Total | 608 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 2 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 2 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 0 |
Baseline characteristics
| Characteristic | Desloratadine 5 mg | Desloratadine 10 mg | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 34.3 Years STANDARD_DEVIATION 13.1 | 33.7 Years STANDARD_DEVIATION 11.9 | 34.7 Years STANDARD_DEVIATION 12.6 | 34.2 Years STANDARD_DEVIATION 12.5 |
| Sex: Female, Male Female | 116 Participants | 105 Participants | 121 Participants | 342 Participants |
| Sex: Female, Male Male | 87 Participants | 98 Participants | 81 Participants | 266 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 | 11 / 202 | 17 / 203 | 9 / 201 |
| serious Total, serious adverse events | 1 / 202 | 0 / 203 | 0 / 201 |
Outcome results
Primary
Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Week 2
The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). The TNSS is the sum of the 4 nasal symptom sub-scores. TNSS scores could range from 0 to 12, with a higher score indicating more frequent/severe nasal symptoms.
Time frame: Baseline and Week 2
Population: The Full Analysis Set (FAS) population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for TNSS.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Desloratadine 5 mg | Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Week 2 | -1.96 Score on a Scale | 95% Confidence Interval 2.21 |
| Desloratadine 10 mg | Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Week 2 | -1.94 Score on a Scale | 95% Confidence Interval 2.21 |
| Placebo | Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Week 2 | -1.87 Score on a Scale | 95% Confidence Interval 2.34 |
p-value: 0.66195% CI: [-0.49, 0.31]Constrained Longitudinal Data Analysis
p-value: 0.70795% CI: [-0.48, 0.32]Constrained Longitudinal Data Analysis
Primary
Number of Participants Discontinuing Study Drug Due to an AE
An AE is defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of the study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE. The number of participants who discontinued study drug, whether permanently or temporarily, due to an AE was summarized.
Time frame: Up to Week 2
Population: The ASaT population consisted of all participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Desloratadine 5 mg | Number of Participants Discontinuing Study Drug Due to an AE | 1 Participants |
| Desloratadine 10 mg | Number of Participants Discontinuing Study Drug Due to an AE | 0 Participants |
| Placebo | Number of Participants Discontinuing Study Drug Due to an AE | 2 Participants |
Primary
Number of Participants Experiencing an Adverse Event (AE)
An AE is defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of the study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE. The number of participants who experienced an AE, regardless of causality or severity, was summarized.
Time frame: Up to Week 4
Population: The All-Subjects-as-Treated (ASaT) population consisted of all participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Desloratadine 5 mg | Number of Participants Experiencing an Adverse Event (AE) | 27 Participants |
| Desloratadine 10 mg | Number of Participants Experiencing an Adverse Event (AE) | 29 Participants |
| Placebo | Number of Participants Experiencing an Adverse Event (AE) | 20 Participants |
Secondary
Change From Baseline in Eye Symptom Score Assessed by the Investigator
The investigator interviewed and examined participants for eye (itching) symptoms (score of 0=none to 3=eye is itchy, requiring frequent rubbing of eye). Eye symptom scores could range from 0 to 3, with a higher score indicating greater eye itchiness.
Time frame: Baseline and Day 3, Week 1, Week 2
Population: The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for eye symptom score as assessed by the investigator.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Desloratadine 5 mg | Change From Baseline in Eye Symptom Score Assessed by the Investigator | Change from BL at Week 1 | -0.28 Score on a Scale | 95% Confidence Interval 0.76 |
| Desloratadine 5 mg | Change From Baseline in Eye Symptom Score Assessed by the Investigator | Change from BL at Day 3 | -0.17 Score on a Scale | 95% Confidence Interval 0.76 |
| Desloratadine 5 mg | Change From Baseline in Eye Symptom Score Assessed by the Investigator | Change from BL at Week 2 | -0.38 Score on a Scale | 95% Confidence Interval 0.84 |
| Desloratadine 10 mg | Change From Baseline in Eye Symptom Score Assessed by the Investigator | Change from BL at Week 1 | -0.35 Score on a Scale | 95% Confidence Interval 0.76 |
| Desloratadine 10 mg | Change From Baseline in Eye Symptom Score Assessed by the Investigator | Change from BL at Day 3 | -0.24 Score on a Scale | 95% Confidence Interval 0.71 |
| Desloratadine 10 mg | Change From Baseline in Eye Symptom Score Assessed by the Investigator | Change from BL at Week 2 | -0.44 Score on a Scale | 95% Confidence Interval 0.77 |
| Placebo | Change From Baseline in Eye Symptom Score Assessed by the Investigator | Change from BL at Day 3 | -0.13 Score on a Scale | 95% Confidence Interval 0.74 |
| Placebo | Change From Baseline in Eye Symptom Score Assessed by the Investigator | Change from BL at Week 2 | -0.37 Score on a Scale | 95% Confidence Interval 0.79 |
| Placebo | Change From Baseline in Eye Symptom Score Assessed by the Investigator | Change from BL at Week 1 | -0.26 Score on a Scale | 95% Confidence Interval 0.83 |
p-value: 0.84995% CI: [-0.14, 0.12]Constrained Longitudinal Data Analysis
p-value: 0.2695% CI: [-0.2, 0.06]Constrained Longitudinal Data Analysis
Secondary
Change From Baseline in Eye Symptom Score Reported in Participant Diaries
Participants evaluated themselves in their daily allergy diaries for eye (itching) symptoms (score of 0=none to 3=eye is itchy, requiring frequent rubbing of eye). Eye symptom scores could range from 0 to 3, with a higher score indicating greater eye itchiness.
Time frame: Baseline and Day 3, Week 1, Week 2
Population: The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for participant-rated eye symptom score.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Desloratadine 5 mg | Change From Baseline in Eye Symptom Score Reported in Participant Diaries | Change from BL at Week 1 | -0.31 Score on a Scale | 95% Confidence Interval 0.82 |
| Desloratadine 5 mg | Change From Baseline in Eye Symptom Score Reported in Participant Diaries | Change from BL at Day 3 | -0.28 Score on a Scale | 95% Confidence Interval 0.73 |
| Desloratadine 5 mg | Change From Baseline in Eye Symptom Score Reported in Participant Diaries | Change from BL at Week 2 | -0.33 Score on a Scale | 95% Confidence Interval 0.8 |
| Desloratadine 10 mg | Change From Baseline in Eye Symptom Score Reported in Participant Diaries | Change from BL at Week 1 | -0.33 Score on a Scale | 95% Confidence Interval 0.75 |
| Desloratadine 10 mg | Change From Baseline in Eye Symptom Score Reported in Participant Diaries | Change from BL at Day 3 | -0.25 Score on a Scale | 95% Confidence Interval 0.72 |
| Desloratadine 10 mg | Change From Baseline in Eye Symptom Score Reported in Participant Diaries | Change from BL at Week 2 | -0.35 Score on a Scale | 95% Confidence Interval 0.82 |
| Placebo | Change From Baseline in Eye Symptom Score Reported in Participant Diaries | Change from BL at Day 3 | -0.20 Score on a Scale | 95% Confidence Interval 0.83 |
| Placebo | Change From Baseline in Eye Symptom Score Reported in Participant Diaries | Change from BL at Week 2 | -0.27 Score on a Scale | 95% Confidence Interval 0.84 |
| Placebo | Change From Baseline in Eye Symptom Score Reported in Participant Diaries | Change from BL at Week 1 | -0.26 Score on a Scale | 95% Confidence Interval 0.8 |
p-value: 0.41495% CI: [-0.2, 0.08]Constrained Longitudinal Data Analysis
p-value: 0.28195% CI: [-0.22, 0.06]Constrained Longitudinal Data Analysis
Secondary
Change From Baseline in Nasal Finding Score Assessed by the Investigator
The investigator conducted rhinoscopic examinations on participants to evaluate: swelling of inferior nasal concha mucosa (INCM) (score of 0=none to 3=middle nasal concha is not visible), coloring of inferior nasal concha mucosa (INCM) (score of 0=normal to 3=pale), and nasal discharge production (NDP) (score of 0=none to 3=congesting). The score for each nasal finding component could range from 0 to 3, with a higher score indicating more severe symptoms.
Time frame: Baseline and Day 3, Week 1, Week 2
Population: The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for nasal finding score.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Desloratadine 5 mg | Change From Baseline in Nasal Finding Score Assessed by the Investigator | Coloring of INCM: Change from BL at Day 3 | -0.27 Score on a Scale | 95% Confidence Interval 0.86 |
| Desloratadine 5 mg | Change From Baseline in Nasal Finding Score Assessed by the Investigator | NDP: Change from BL at Week 2 | -0.41 Score on a Scale | 95% Confidence Interval 0.71 |
| Desloratadine 5 mg | Change From Baseline in Nasal Finding Score Assessed by the Investigator | Coloring of INCM: Change from BL at Week 2 | -0.48 Score on a Scale | 95% Confidence Interval 0.97 |
| Desloratadine 5 mg | Change From Baseline in Nasal Finding Score Assessed by the Investigator | Coloring of INCM: Change from BL at Week 1 | -0.35 Score on a Scale | 95% Confidence Interval 0.88 |
| Desloratadine 5 mg | Change From Baseline in Nasal Finding Score Assessed by the Investigator | Swelling of INCM: Change from BL at Day 3 | -0.23 Score on a Scale | 95% Confidence Interval 0.7 |
| Desloratadine 5 mg | Change From Baseline in Nasal Finding Score Assessed by the Investigator | NDP: Change from BL at Week 1 | -0.33 Score on a Scale | 95% Confidence Interval 0.75 |
| Desloratadine 5 mg | Change From Baseline in Nasal Finding Score Assessed by the Investigator | Swelling of INCM: Change from BL at Week 2 | -0.38 Score on a Scale | 95% Confidence Interval 0.74 |
| Desloratadine 5 mg | Change From Baseline in Nasal Finding Score Assessed by the Investigator | Swelling of INCM: Change from BL at Week 1 | -0.35 Score on a Scale | 95% Confidence Interval 0.71 |
| Desloratadine 5 mg | Change From Baseline in Nasal Finding Score Assessed by the Investigator | NDP: Change from BL at Day 3 | -0.23 Score on a Scale | 95% Confidence Interval 0.76 |
| Desloratadine 10 mg | Change From Baseline in Nasal Finding Score Assessed by the Investigator | Coloring of INCM: Change from BL at Week 1 | -0.38 Score on a Scale | 95% Confidence Interval 0.89 |
| Desloratadine 10 mg | Change From Baseline in Nasal Finding Score Assessed by the Investigator | Swelling of INCM: Change from BL at Day 3 | -0.17 Score on a Scale | 95% Confidence Interval 0.68 |
| Desloratadine 10 mg | Change From Baseline in Nasal Finding Score Assessed by the Investigator | Swelling of INCM: Change from BL at Week 1 | -0.31 Score on a Scale | 95% Confidence Interval 0.69 |
| Desloratadine 10 mg | Change From Baseline in Nasal Finding Score Assessed by the Investigator | Swelling of INCM: Change from BL at Week 2 | -0.34 Score on a Scale | 95% Confidence Interval 0.71 |
| Desloratadine 10 mg | Change From Baseline in Nasal Finding Score Assessed by the Investigator | Coloring of INCM: Change from BL at Day 3 | -0.26 Score on a Scale | 95% Confidence Interval 0.79 |
| Desloratadine 10 mg | Change From Baseline in Nasal Finding Score Assessed by the Investigator | Coloring of INCM: Change from BL at Week 2 | -0.48 Score on a Scale | 95% Confidence Interval 0.85 |
| Desloratadine 10 mg | Change From Baseline in Nasal Finding Score Assessed by the Investigator | NDP: Change from BL at Day 3 | -0.24 Score on a Scale | 95% Confidence Interval 0.75 |
| Desloratadine 10 mg | Change From Baseline in Nasal Finding Score Assessed by the Investigator | NDP: Change from BL at Week 1 | -0.36 Score on a Scale | 95% Confidence Interval 0.75 |
| Desloratadine 10 mg | Change From Baseline in Nasal Finding Score Assessed by the Investigator | NDP: Change from BL at Week 2 | -0.38 Score on a Scale | 95% Confidence Interval 0.76 |
| Placebo | Change From Baseline in Nasal Finding Score Assessed by the Investigator | Swelling of INCM: Change from BL at Week 2 | -0.32 Score on a Scale | 95% Confidence Interval 0.82 |
| Placebo | Change From Baseline in Nasal Finding Score Assessed by the Investigator | Swelling of INCM: Change from BL at Day 3 | -0.13 Score on a Scale | 95% Confidence Interval 0.71 |
| Placebo | Change From Baseline in Nasal Finding Score Assessed by the Investigator | NDP: Change from BL at Day 3 | -0.18 Score on a Scale | 95% Confidence Interval 0.65 |
| Placebo | Change From Baseline in Nasal Finding Score Assessed by the Investigator | Swelling of INCM: Change from BL at Week 1 | -0.34 Score on a Scale | 95% Confidence Interval 0.78 |
| Placebo | Change From Baseline in Nasal Finding Score Assessed by the Investigator | NDP: Change from BL at Week 2 | -0.44 Score on a Scale | 95% Confidence Interval 0.76 |
| Placebo | Change From Baseline in Nasal Finding Score Assessed by the Investigator | Coloring of INCM: Change from BL at Week 1 | -0.40 Score on a Scale | 95% Confidence Interval 0.91 |
| Placebo | Change From Baseline in Nasal Finding Score Assessed by the Investigator | Coloring of INCM: Change from BL at Day 3 | -0.26 Score on a Scale | 95% Confidence Interval 0.81 |
| Placebo | Change From Baseline in Nasal Finding Score Assessed by the Investigator | NDP: Change from BL at Week 1 | -0.41 Score on a Scale | 95% Confidence Interval 0.75 |
| Placebo | Change From Baseline in Nasal Finding Score Assessed by the Investigator | Coloring of INCM: Change from BL at Week 2 | -0.45 Score on a Scale | 95% Confidence Interval 0.96 |
p-value: 0.37695% CI: [-0.2, 0.07]Constrained Longitudinal Data Analysis
p-value: 0.71495% CI: [-0.16, 0.11]Constrained Longitudinal Data Analysis
p-value: 0.72595% CI: [-0.19, 0.13]Constrained Longitudinal Data Analysis
p-value: 0.70895% CI: [-0.19, 0.13]Constrained Longitudinal Data Analysis
p-value: 0.6895% CI: [-0.1, 0.16]Constrained Longitudinal Data Analysis
p-value: 0.37395% CI: [-0.07, 0.19]Constrained Longitudinal Data Analysis
Secondary
Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator
The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attackes; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores could range from 0 to 3, with a higher nasal symptom sub-score indicating more frequent/severe nasal symptoms.
Time frame: Baseline and Day 3, Week 1, Week 2
Population: The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for nasal symptom sub-scores as assessed by the investigator.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Desloratadine 5 mg | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Sneezing: Change from BL at Day 3 | -0.21 Score on a Scale | 95% Confidence Interval 0.75 |
| Desloratadine 5 mg | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Sneezing: Change from BL at Week 1 | -0.27 Score on a Scale | 95% Confidence Interval 0.78 |
| Desloratadine 5 mg | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Sneezing: Change from BL at Week 2 | -0.44 Score on a Scale | 95% Confidence Interval 0.74 |
| Desloratadine 5 mg | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Rhinorrhea: Change from BL at Day 3 | -0.37 Score on a Scale | 95% Confidence Interval 0.66 |
| Desloratadine 5 mg | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Rhinorrhea: Change from BL at Week 1 | -0.39 Score on a Scale | 95% Confidence Interval 0.77 |
| Desloratadine 5 mg | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Rhinorrhea: Change from BL at Week 2 | -0.57 Score on a Scale | 95% Confidence Interval 0.73 |
| Desloratadine 5 mg | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Nasal Congestion: Change from BL at Day 3 | -0.22 Score on a Scale | 95% Confidence Interval 0.68 |
| Desloratadine 5 mg | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Nasal Congestion: Change from BL at Week 1 | -0.28 Score on a Scale | 95% Confidence Interval 0.81 |
| Desloratadine 5 mg | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Nasal Congestion: Change from BL at Week 2 | -0.33 Score on a Scale | 95% Confidence Interval 0.78 |
| Desloratadine 5 mg | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Nasal Itching: Change from BL at Day 3 | -0.32 Score on a Scale | 95% Confidence Interval 0.79 |
| Desloratadine 5 mg | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Nasal Itching: Change from BL at Week 1 | -0.44 Score on a Scale | 95% Confidence Interval 0.84 |
| Desloratadine 5 mg | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Nasal Itching: Change from BL at Week 2 | -0.63 Score on a Scale | 95% Confidence Interval 0.91 |
| Desloratadine 10 mg | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Nasal Itching: Change from BL at Week 2 | -0.58 Score on a Scale | 95% Confidence Interval 0.86 |
| Desloratadine 10 mg | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Sneezing: Change from BL at Day 3 | -0.29 Score on a Scale | 95% Confidence Interval 0.67 |
| Desloratadine 10 mg | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Nasal Congestion: Change from BL at Day 3 | -0.17 Score on a Scale | 95% Confidence Interval 0.68 |
| Desloratadine 10 mg | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Nasal Congestion: Change from BL at Week 2 | -0.33 Score on a Scale | 95% Confidence Interval 0.75 |
| Desloratadine 10 mg | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Sneezing: Change from BL at Week 1 | -0.36 Score on a Scale | 95% Confidence Interval 0.75 |
| Desloratadine 10 mg | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Rhinorrhea: Change from BL at Week 2 | -0.53 Score on a Scale | 95% Confidence Interval 0.83 |
| Desloratadine 10 mg | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Nasal Itching: Change from BL at Week 1 | -0.44 Score on a Scale | 95% Confidence Interval 0.88 |
| Desloratadine 10 mg | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Sneezing: Change from BL at Week 2 | -0.51 Score on a Scale | 95% Confidence Interval 0.69 |
| Desloratadine 10 mg | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Nasal Congestion: Change from BL at Week 1 | -0.22 Score on a Scale | 95% Confidence Interval 0.7 |
| Desloratadine 10 mg | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Rhinorrhea: Change from BL at Week 1 | -0.38 Score on a Scale | 95% Confidence Interval 0.83 |
| Desloratadine 10 mg | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Rhinorrhea: Change from BL at Day 3 | -0.32 Score on a Scale | 95% Confidence Interval 0.73 |
| Desloratadine 10 mg | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Nasal Itching: Change from BL at Day 3 | -0.33 Score on a Scale | 95% Confidence Interval 0.82 |
| Placebo | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Rhinorrhea: Change from BL at Day 3 | -0.24 Score on a Scale | 95% Confidence Interval 0.74 |
| Placebo | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Rhinorrhea: Change from BL at Week 1 | -0.44 Score on a Scale | 95% Confidence Interval 0.78 |
| Placebo | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Nasal Itching: Change from BL at Day 3 | -0.15 Score on a Scale | 95% Confidence Interval 0.8 |
| Placebo | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Rhinorrhea: Change from BL at Week 2 | -0.56 Score on a Scale | 95% Confidence Interval 0.83 |
| Placebo | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Nasal Congestion: Change from BL at Day 3 | -0.13 Score on a Scale | 95% Confidence Interval 0.65 |
| Placebo | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Nasal Congestion: Change from BL at Week 1 | -0.32 Score on a Scale | 95% Confidence Interval 0.73 |
| Placebo | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Nasal Itching: Change from BL at Week 1 | -0.35 Score on a Scale | 95% Confidence Interval 0.88 |
| Placebo | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Sneezing: Change from BL at Day 3 | -0.13 Score on a Scale | 95% Confidence Interval 0.65 |
| Placebo | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Sneezing: Change from BL at Week 1 | -0.38 Score on a Scale | 95% Confidence Interval 0.76 |
| Placebo | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Nasal Congestion: Change from BL at Week 2 | -0.37 Score on a Scale | 95% Confidence Interval 0.77 |
| Placebo | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Sneezing: Change from BL at Week 2 | -0.40 Score on a Scale | 95% Confidence Interval 0.73 |
| Placebo | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Nasal Itching: Change from BL at Week 2 | -0.52 Score on a Scale | 95% Confidence Interval 0.84 |
p-value: 0.54795% CI: [-0.15, 0.08]Constrained Longitudinal Data Analysis
p-value: 0.06795% CI: [-0.22, 0.01]Constrained Longitudinal Data Analysis
p-value: 0.89595% CI: [-0.15, 0.13]Constrained Longitudinal Data Analysis
p-value: 0.62795% CI: [-0.1, 0.17]Constrained Longitudinal Data Analysis
p-value: 0.53595% CI: [-0.09, 0.18]Constrained Longitudinal Data Analysis
p-value: 0.55795% CI: [-0.1, 0.18]Constrained Longitudinal Data Analysis
p-value: 0.11995% CI: [-0.25, 0.03]Constrained Longitudinal Data Analysis
p-value: 0.40395% CI: [-0.2, 0.08]Constrained Longitudinal Data Analysis
Secondary
Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries
Participants evaluated themselves in their daily allergy diaries for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). Each nasal symptom sub-score could range from 0 to 3, with a higher sub-score indicating more frequent/severe nasal symptoms.
Time frame: Baseline and Day 3, Week 1, Week 2
Population: The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for participant-rated nasal symptom score.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Desloratadine 5 mg | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Sneezing: Change from BL at Day 3 | -0.27 Score on a Scale | 95% Confidence Interval 0.72 |
| Desloratadine 5 mg | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Sneezing: Change from BL at Week 1 | -0.38 Score on a Scale | 95% Confidence Interval 0.72 |
| Desloratadine 5 mg | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Sneezing: Change from BL at Week 2 | -0.43 Score on a Scale | 95% Confidence Interval 0.81 |
| Desloratadine 5 mg | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Rhinorrhea: Change from BL at Day 3 | -0.20 Score on a Scale | 95% Confidence Interval 0.76 |
| Desloratadine 5 mg | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Rhinorrhea: Change from BL at Week 1 | -0.29 Score on a Scale | 95% Confidence Interval 0.81 |
| Desloratadine 5 mg | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Rhinorrhea: Change from BL at Week 2 | -0.33 Score on a Scale | 95% Confidence Interval 0.85 |
| Desloratadine 5 mg | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Nasal Congestion: Change from BL at Day 3 | -0.18 Score on a Scale | 95% Confidence Interval 0.71 |
| Desloratadine 5 mg | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Nasal Congestion: Change from BL at Week 1 | -0.23 Score on a Scale | 95% Confidence Interval 0.69 |
| Desloratadine 5 mg | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Nasal Congestion: Change from BL at Week 2 | -0.23 Score on a Scale | 95% Confidence Interval 0.76 |
| Desloratadine 5 mg | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Nasal Itching: Change from BL at Day 3 | -0.29 Score on a Scale | 95% Confidence Interval 0.76 |
| Desloratadine 5 mg | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Nasal Itching: Change from BL at Week 1 | -0.40 Score on a Scale | 95% Confidence Interval 0.88 |
| Desloratadine 5 mg | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Nasal Itching: Change from BL at Week 2 | -0.52 Score on a Scale | 95% Confidence Interval 0.92 |
| Desloratadine 10 mg | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Nasal Itching: Change from BL at Week 2 | -0.47 Score on a Scale | 95% Confidence Interval 0.9 |
| Desloratadine 10 mg | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Sneezing: Change from BL at Day 3 | -0.32 Score on a Scale | 95% Confidence Interval 0.76 |
| Desloratadine 10 mg | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Nasal Congestion: Change from BL at Day 3 | -0.17 Score on a Scale | 95% Confidence Interval 0.73 |
| Desloratadine 10 mg | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Nasal Congestion: Change from BL at Week 2 | -0.26 Score on a Scale | 95% Confidence Interval 0.88 |
| Desloratadine 10 mg | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Sneezing: Change from BL at Week 1 | -0.40 Score on a Scale | 95% Confidence Interval 0.84 |
| Desloratadine 10 mg | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Rhinorrhea: Change from BL at Week 2 | -0.38 Score on a Scale | 95% Confidence Interval 0.86 |
| Desloratadine 10 mg | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Nasal Itching: Change from BL at Week 1 | -0.42 Score on a Scale | 95% Confidence Interval 0.8 |
| Desloratadine 10 mg | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Sneezing: Change from BL at Week 2 | -0.45 Score on a Scale | 95% Confidence Interval 0.86 |
| Desloratadine 10 mg | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Nasal Congestion: Change from BL at Week 1 | -0.24 Score on a Scale | 95% Confidence Interval 0.79 |
| Desloratadine 10 mg | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Rhinorrhea: Change from BL at Week 1 | -0.36 Score on a Scale | 95% Confidence Interval 0.81 |
| Desloratadine 10 mg | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Rhinorrhea: Change from BL at Day 3 | -0.29 Score on a Scale | 95% Confidence Interval 0.74 |
| Desloratadine 10 mg | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Nasal Itching: Change from BL at Day 3 | -0.35 Score on a Scale | 95% Confidence Interval 0.85 |
| Placebo | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Rhinorrhea: Change from BL at Day 3 | -0.17 Score on a Scale | 95% Confidence Interval 0.8 |
| Placebo | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Rhinorrhea: Change from BL at Week 1 | -0.34 Score on a Scale | 95% Confidence Interval 0.84 |
| Placebo | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Nasal Itching: Change from BL at Day 3 | -0.22 Score on a Scale | 95% Confidence Interval 0.77 |
| Placebo | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Rhinorrhea: Change from BL at Week 2 | -0.45 Score on a Scale | 95% Confidence Interval 0.88 |
| Placebo | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Nasal Congestion: Change from BL at Day 3 | -0.18 Score on a Scale | 95% Confidence Interval 0.75 |
| Placebo | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Nasal Congestion: Change from BL at Week 1 | -0.25 Score on a Scale | 95% Confidence Interval 0.83 |
| Placebo | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Nasal Itching: Change from BL at Week 1 | -0.39 Score on a Scale | 95% Confidence Interval 0.87 |
| Placebo | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Sneezing: Change from BL at Day 3 | -0.23 Score on a Scale | 95% Confidence Interval 0.79 |
| Placebo | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Sneezing: Change from BL at Week 1 | -0.30 Score on a Scale | 95% Confidence Interval 0.75 |
| Placebo | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Nasal Congestion: Change from BL at Week 2 | -0.32 Score on a Scale | 95% Confidence Interval 0.78 |
| Placebo | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Sneezing: Change from BL at Week 2 | -0.33 Score on a Scale | 95% Confidence Interval 0.81 |
| Placebo | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Nasal Itching: Change from BL at Week 2 | -0.44 Score on a Scale | 95% Confidence Interval 0.87 |
p-value: 0.17595% CI: [-0.24, 0.04]Constrained Longitudinal Data Analysis
p-value: 0.09895% CI: [-0.26, 0.02]Constrained Longitudinal Data Analysis
p-value: 0.1395% CI: [-0.04, 0.27]Constrained Longitudinal Data Analysis
p-value: 0.37595% CI: [-0.08, 0.22]Constrained Longitudinal Data Analysis
p-value: 0.28595% CI: [-0.07, 0.24]Constrained Longitudinal Data Analysis
p-value: 0.4995% CI: [-0.1, 0.21]Constrained Longitudinal Data Analysis
p-value: 0.34595% CI: [-0.23, 0.08]Constrained Longitudinal Data Analysis
p-value: 0.69995% CI: [-0.19, 0.13]Constrained Longitudinal Data Analysis
Secondary
Change From Baseline in Score on Interference With Daily Activities Assessed by the Investigator
The investigator interviewed participants at Baseline, Day 3, Week 1 and Week 2 to evaluate interference with daily activities according to the following scale: 0=none, 1=nasal symptom interferes with daily activities from time to time (+), 2=between 1 and 3 (++), and 3=nasal symtom interferes with daily activity often (+++). Interference with daily activities scores could range from 0 to 3, with a higher score indicating greater interference with daily activities.
Time frame: Baseline and Day 3, Week 1, Week 2
Population: The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for interference with daily activities.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Desloratadine 5 mg | Change From Baseline in Score on Interference With Daily Activities Assessed by the Investigator | Change from BL at Week 1 | -0.22 Score on a Scale | 95% Confidence Interval 0.69 |
| Desloratadine 5 mg | Change From Baseline in Score on Interference With Daily Activities Assessed by the Investigator | Change from BL at Day 3 | -0.18 Score on a Scale | 95% Confidence Interval 0.63 |
| Desloratadine 5 mg | Change From Baseline in Score on Interference With Daily Activities Assessed by the Investigator | Change from BL at Week 2 | -0.25 Score on a Scale | 95% Confidence Interval 0.73 |
| Desloratadine 10 mg | Change From Baseline in Score on Interference With Daily Activities Assessed by the Investigator | Change from BL at Week 1 | -0.21 Score on a Scale | 95% Confidence Interval 0.68 |
| Desloratadine 10 mg | Change From Baseline in Score on Interference With Daily Activities Assessed by the Investigator | Change from BL at Day 3 | -0.19 Score on a Scale | 95% Confidence Interval 0.58 |
| Desloratadine 10 mg | Change From Baseline in Score on Interference With Daily Activities Assessed by the Investigator | Change from BL at Week 2 | -0.29 Score on a Scale | 95% Confidence Interval 0.69 |
| Placebo | Change From Baseline in Score on Interference With Daily Activities Assessed by the Investigator | Change from BL at Day 3 | -0.07 Score on a Scale | 95% Confidence Interval 0.62 |
| Placebo | Change From Baseline in Score on Interference With Daily Activities Assessed by the Investigator | Change from BL at Week 2 | -0.27 Score on a Scale | 95% Confidence Interval 0.71 |
| Placebo | Change From Baseline in Score on Interference With Daily Activities Assessed by the Investigator | Change from BL at Week 1 | -0.20 Score on a Scale | 95% Confidence Interval 0.64 |
p-value: 0.70595% CI: [-0.09, 0.14]Constrained Longitudinal Data Analysis
p-value: 0.78295% CI: [-0.13, 0.1]Constrained Longitudinal Data Analysis
Secondary
Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Day 3 and Week 1
The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). The TNSS is the sum of the 4 nasal symptom sub-scores. TNSS scores could range from 0 to 12, with a higher score indicating more frequent/severe nasal symptoms.
Time frame: Baseline and Day 3, Week 1
Population: The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for TNSS.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Desloratadine 5 mg | Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Day 3 and Week 1 | Change from Baseline (BL) at Day 3 | -1.12 Score on a Scale | 95% Confidence Interval 2.05 |
| Desloratadine 5 mg | Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Day 3 and Week 1 | Change from BL at Week 1 | -1.39 Score on a Scale | 95% Confidence Interval 2.41 |
| Desloratadine 10 mg | Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Day 3 and Week 1 | Change from Baseline (BL) at Day 3 | -1.11 Score on a Scale | 95% Confidence Interval 2.02 |
| Desloratadine 10 mg | Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Day 3 and Week 1 | Change from BL at Week 1 | -1.39 Score on a Scale | 95% Confidence Interval 2.28 |
| Placebo | Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Day 3 and Week 1 | Change from Baseline (BL) at Day 3 | -0.63 Score on a Scale | 95% Confidence Interval 2.03 |
| Placebo | Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Day 3 and Week 1 | Change from BL at Week 1 | -1.48 Score on a Scale | 95% Confidence Interval 2.32 |
p-value: 0.0195% CI: [-0.84, -0.11]Constrained Longitudinal Data Analysis
p-value: 0.01395% CI: [-0.82, -0.1]Constrained Longitudinal Data Analysis
p-value: 0.56995% CI: [-0.29, 0.53]Constrained Longitudinal Data Analysis
p-value: 0.68595% CI: [-0.33, 0.5]Constrained Longitudinal Data Analysis
Secondary
Number of Participants With Moderate-to-Remarkable Improvement in Global Improvement Assessed by the Investigator
The investigator comprehensively evaluated participants on global improvement according to 5 grades: 1=remarkably improved, 2= moderately improved, 3=slightly improved, 4=unchanged, and 5=aggravated. The number of participants who were evaluated as remarkably improved and moderately improved was calculated.
Time frame: Day 3, Week 1, Week 2
Population: The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for global improvement.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Desloratadine 5 mg | Number of Participants With Moderate-to-Remarkable Improvement in Global Improvement Assessed by the Investigator | Week 1 (n=200, 203, 201) | 72 Participants |
| Desloratadine 5 mg | Number of Participants With Moderate-to-Remarkable Improvement in Global Improvement Assessed by the Investigator | Day 3 (n=199, 201, 200) | 67 Participants |
| Desloratadine 5 mg | Number of Participants With Moderate-to-Remarkable Improvement in Global Improvement Assessed by the Investigator | Week 2 (n=200, 203, 201) | 96 Participants |
| Desloratadine 10 mg | Number of Participants With Moderate-to-Remarkable Improvement in Global Improvement Assessed by the Investigator | Week 1 (n=200, 203, 201) | 83 Participants |
| Desloratadine 10 mg | Number of Participants With Moderate-to-Remarkable Improvement in Global Improvement Assessed by the Investigator | Day 3 (n=199, 201, 200) | 61 Participants |
| Desloratadine 10 mg | Number of Participants With Moderate-to-Remarkable Improvement in Global Improvement Assessed by the Investigator | Week 2 (n=200, 203, 201) | 93 Participants |
| Placebo | Number of Participants With Moderate-to-Remarkable Improvement in Global Improvement Assessed by the Investigator | Day 3 (n=199, 201, 200) | 53 Participants |
| Placebo | Number of Participants With Moderate-to-Remarkable Improvement in Global Improvement Assessed by the Investigator | Week 2 (n=200, 203, 201) | 106 Participants |
| Placebo | Number of Participants With Moderate-to-Remarkable Improvement in Global Improvement Assessed by the Investigator | Week 1 (n=200, 203, 201) | 91 Participants |
p-value: 0.3495% CI: [0.558, 1.223]Regression, Logistic
p-value: 0.15995% CI: [0.51, 1.116]Regression, Logistic