A Phase 3 interventional study of Desloratadine 5 mg and Placebo in Perennial Allergic Rhinitis, sponsored by Organon and Co. Completed. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2024-06-18.
Sponsored by Organon and Co · Phase 3, Interventional, and Treatment
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.
186 studies on the registry are indexed under Rhinitis, Allergic, Perennial; 8 are open to participants now.
This study's enrollment of 608 is above the median of 131 across 164 interventional studies indexed under Rhinitis, Allergic, Perennial.
Browse Rhinitis, Allergic, Perennial studies →Organon and Co is the lead sponsor of 505 studies on the registry; none are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.
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Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
Drug: Desloratadine 5 mg · Drug: Placebo
Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
Drug: Desloratadine 5 mg
Participants receive two placebo tablets orally once daily for up to 2 weeks
Drug: Placebo
Desloratadine 5 mg tablets
Matching placebo to desloratadine 5 mg tablets
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
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
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
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
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
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
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
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
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
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
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
| Milestone | Desloratadine 5 mg | Desloratadine 10 mg | Placebo |
|---|---|---|---|
| Started | 203 | 203 | 202 |
| Treated | 202 | 203 | 201 |
| Completed | 198 | 201 | 199 |
| Not completed | 5 | 2 | 3 |
| Withdrew: Adverse event | 1 | 0 | 2 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 |
| Withdrew: Protocol violation | 2 | 0 | 1 |
| Withdrew: Withdrawal by subject | 2 | 1 | 0 |
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.
| Score on a Scale | Desloratadine 5 mg | Desloratadine 10 mg | Placebo |
|---|---|---|---|
| Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Week 2 | -1.96 ± 2.21 | -1.94 ± 2.21 | -1.87 ± 2.34 |
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.
| Participants | Desloratadine 5 mg | Desloratadine 10 mg | Placebo |
|---|---|---|---|
| Number of Participants Experiencing an Adverse Event (AE) | 27 | 29 | 20 |
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.
| Participants | Desloratadine 5 mg | Desloratadine 10 mg | Placebo |
|---|---|---|---|
| Number of Participants Discontinuing Study Drug Due to an AE | 1 | 0 | 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.
| Score on a Scale | Desloratadine 5 mg | Desloratadine 10 mg | Placebo |
|---|---|---|---|
| Change from Baseline (BL) at Day 3 | -1.12 ± 2.05 | -1.11 ± 2.02 | -0.63 ± 2.03 |
| Change from BL at Week 1 | -1.39 ± 2.41 | -1.39 ± 2.28 | -1.48 ± 2.32 |
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.
| Score on a Scale | Desloratadine 5 mg | Desloratadine 10 mg | Placebo |
|---|---|---|---|
| Sneezing: Change from BL at Day 3 | -0.21 ± 0.75 | -0.29 ± 0.67 | -0.13 ± 0.65 |
| Sneezing: Change from BL at Week 1 | -0.27 ± 0.78 | -0.36 ± 0.75 | -0.38 ± 0.76 |
| Sneezing: Change from BL at Week 2 | -0.44 ± 0.74 | -0.51 ± 0.69 | -0.40 ± 0.73 |
| Rhinorrhea: Change from BL at Day 3 | -0.37 ± 0.66 | -0.32 ± 0.73 | -0.24 ± 0.74 |
| Rhinorrhea: Change from BL at Week 1 | -0.39 ± 0.77 | -0.38 ± 0.83 | -0.44 ± 0.78 |
| Rhinorrhea: Change from BL at Week 2 | -0.57 ± 0.73 | -0.53 ± 0.83 | -0.56 ± 0.83 |
| Nasal Congestion: Change from BL at Day 3 | -0.22 ± 0.68 | -0.17 ± 0.68 | -0.13 ± 0.65 |
| Nasal Congestion: Change from BL at Week 1 | -0.28 ± 0.81 | -0.22 ± 0.70 | -0.32 ± 0.73 |
| Nasal Congestion: Change from BL at Week 2 | -0.33 ± 0.78 | -0.33 ± 0.75 | -0.37 ± 0.77 |
| Nasal Itching: Change from BL at Day 3 | -0.32 ± 0.79 | -0.33 ± 0.82 | -0.15 ± 0.80 |
| Nasal Itching: Change from BL at Week 1 | -0.44 ± 0.84 | -0.44 ± 0.88 | -0.35 ± 0.88 |
| Nasal Itching: Change from BL at Week 2 | -0.63 ± 0.91 | -0.58 ± 0.86 | -0.52 ± 0.84 |
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.
| Score on a Scale | Desloratadine 5 mg | Desloratadine 10 mg | Placebo |
|---|---|---|---|
| Swelling of INCM: Change from BL at Day 3 | -0.23 ± 0.70 | -0.17 ± 0.68 | -0.13 ± 0.71 |
| Swelling of INCM: Change from BL at Week 1 | -0.35 ± 0.71 | -0.31 ± 0.69 | -0.34 ± 0.78 |
| Swelling of INCM: Change from BL at Week 2 | -0.38 ± 0.74 | -0.34 ± 0.71 | -0.32 ± 0.82 |
| Coloring of INCM: Change from BL at Day 3 | -0.27 ± 0.86 | -0.26 ± 0.79 | -0.26 ± 0.81 |
| Coloring of INCM: Change from BL at Week 1 | -0.35 ± 0.88 | -0.38 ± 0.89 | -0.40 ± 0.91 |
| Coloring of INCM: Change from BL at Week 2 | -0.48 ± 0.97 | -0.48 ± 0.85 | -0.45 ± 0.96 |
| NDP: Change from BL at Day 3 | -0.23 ± 0.76 | -0.24 ± 0.75 | -0.18 ± 0.65 |
| NDP: Change from BL at Week 1 | -0.33 ± 0.75 | -0.36 ± 0.75 | -0.41 ± 0.75 |
| NDP: Change from BL at Week 2 | -0.41 ± 0.71 | -0.38 ± 0.76 | -0.44 ± 0.76 |
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.
| Score on a Scale | Desloratadine 5 mg | Desloratadine 10 mg | Placebo |
|---|---|---|---|
| Change from BL at Day 3 | -0.17 ± 0.76 | -0.24 ± 0.71 | -0.13 ± 0.74 |
| Change from BL at Week 1 | -0.28 ± 0.76 | -0.35 ± 0.76 | -0.26 ± 0.83 |
| Change from BL at Week 2 | -0.38 ± 0.84 | -0.44 ± 0.77 | -0.37 ± 0.79 |
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.
| Participants | Desloratadine 5 mg | Desloratadine 10 mg | Placebo |
|---|---|---|---|
| Day 3 (n=199, 201, 200) | 67 | 61 | 53 |
| Week 1 (n=200, 203, 201) | 72 | 83 | 91 |
| Week 2 (n=200, 203, 201) | 96 | 93 | 106 |
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.
| Score on a Scale | Desloratadine 5 mg | Desloratadine 10 mg | Placebo |
|---|---|---|---|
| Change from BL at Day 3 | -0.18 ± 0.63 | -0.19 ± 0.58 | -0.07 ± 0.62 |
| Change from BL at Week 1 | -0.22 ± 0.69 | -0.21 ± 0.68 | -0.20 ± 0.64 |
| Change from BL at Week 2 | -0.25 ± 0.73 | -0.29 ± 0.69 | -0.27 ± 0.71 |
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.
| Score on a Scale | Desloratadine 5 mg | Desloratadine 10 mg | Placebo |
|---|---|---|---|
| Sneezing: Change from BL at Day 3 | -0.27 ± 0.72 | -0.32 ± 0.76 | -0.23 ± 0.79 |
| Sneezing: Change from BL at Week 1 | -0.38 ± 0.72 | -0.40 ± 0.84 | -0.30 ± 0.75 |
| Sneezing: Change from BL at Week 2 | -0.43 ± 0.81 | -0.45 ± 0.86 | -0.33 ± 0.81 |
| Rhinorrhea: Change from BL at Day 3 | -0.20 ± 0.76 | -0.29 ± 0.74 | -0.17 ± 0.80 |
| Rhinorrhea: Change from BL at Week 1 | -0.29 ± 0.81 | -0.36 ± 0.81 | -0.34 ± 0.84 |
| Rhinorrhea: Change from BL at Week 2 | -0.33 ± 0.85 | -0.38 ± 0.86 | -0.45 ± 0.88 |
| Nasal Congestion: Change from BL at Day 3 | -0.18 ± 0.71 | -0.17 ± 0.73 | -0.18 ± 0.75 |
| Nasal Congestion: Change from BL at Week 1 | -0.23 ± 0.69 | -0.24 ± 0.79 | -0.25 ± 0.83 |
| Nasal Congestion: Change from BL at Week 2 | -0.23 ± 0.76 | -0.26 ± 0.88 | -0.32 ± 0.78 |
| Nasal Itching: Change from BL at Day 3 | -0.29 ± 0.76 | -0.35 ± 0.85 | -0.22 ± 0.77 |
| Nasal Itching: Change from BL at Week 1 | -0.40 ± 0.88 | -0.42 ± 0.80 | -0.39 ± 0.87 |
| Nasal Itching: Change from BL at Week 2 | -0.52 ± 0.92 | -0.47 ± 0.90 | -0.44 ± 0.87 |
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.
| Score on a Scale | Desloratadine 5 mg | Desloratadine 10 mg | Placebo |
|---|---|---|---|
| Change from BL at Day 3 | -0.28 ± 0.73 | -0.25 ± 0.72 | -0.20 ± 0.83 |
| Change from BL at Week 1 | -0.31 ± 0.82 | -0.33 ± 0.75 | -0.26 ± 0.80 |
| Change from BL at Week 2 | -0.33 ± 0.80 | -0.35 ± 0.82 | -0.27 ± 0.84 |
Collected over Up to 2 weeks after last dose of study drug (up to 4 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Desloratadine 5 mg | — | 1/202 (0.5%) | 11/202 (5.4%) |
| Desloratadine 10 mg | — | 0/203 (0%) | 17/203 (8.4%) |
| Placebo | — | 0/201 (0%) | 9/201 (4.5%) |
| Event | Desloratadine 5 mg | Desloratadine 10 mg | Placebo |
|---|---|---|---|
| EpilepsyNervous system disorders | 1/202 | 0/203 | 0/201 |
| Event | Desloratadine 5 mg | Desloratadine 10 mg | Placebo |
|---|---|---|---|
| NasphopharyngitisInfections and infestations | 11/202 | 17/203 | 9/201 |
| Age, Continuous(Years) | Desloratadine 5 mg | Desloratadine 10 mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 34.3 ± 13.1 | 33.7 ± 11.9 | 34.7 ± 12.6 | 34.2 ± 12.5 |
| Sex: Female, Male(Participants) | Desloratadine 5 mg | Desloratadine 10 mg | Placebo | Total |
|---|---|---|---|---|
| Female | 116 | 105 | 121 | 342 |
| Male | 87 | 98 | 81 | 266 |
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Studies of the drug tested here: Desloratadine
Rhinitis, Allergic, Perennial →