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Primary aim is to evaluate the efficacy of specific immunotherapy with Pangramin SLIT HDM-mix compared to placebo in the treatment of House Dust Mite (HDM) induced rhinitis with or without asthma.
Sublingual immunotherapy has been used during several years and has been shown to provide benefits compare to traditional subcutaneous treatment. This study will investigate if improvements in rhinitis symptoms and less use of symptomatic medication can be obtained as a consequence of being treated under specific immunotherapy.
This study aim also to contribute to the documentation of tolerability and safety profile of Pangramin HDM Mix.
Extensive clinical experience has been gained due to the widespread use of Pangramin® SLIT and other SLIT products as named patient products, both with respect to the types and the frequencies of the adverse events(AEs) observed. No safety concerns have been found.
The optimal therapeutic dose range regarding SLIT is not fully elucidated. The fate of the allergen after sublingual administration is not known in detail, i.e. to what extent is the allergen absorbed over the mucosa or swallowed and how this is related to volume, excipients etc. The relationship between dose and effect is thus not fully elucidated. The general recommendation is to use a dose inducing a clinical relevant effect in most patients without causing unacceptable adverse events. As Pangramin SLIT HDM-mix has a safety profile that allows a single daily intake by the patient at home, the dosage at this trial will be the same as marketed product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PANGRAMIN SLIT HDM MIX | Experimental | PANGRAMIN SLIT HDM MIX Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months. |
|
| Placebo | Placebo Comparator | Placebo Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pangramin SLIT HDM mix. | Biological | Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Change From Baseline in Rhinoconjunctivitis Symptoms Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated. | Subjects completed symptom assessments and recorded the results in the patient diary cards on a daily basis. A total of six rhinoconjunctivitis symptoms were measured on a scale from 0-3 as follows: 0 = No symptoms.
The six symptoms are classified in 2 groups as follows: Nose symptoms: Runny nose, Blocked nose, Sneezing, Itchy nose; Eye symptoms: Gritty feeling/red/itchy eyes, Watery eyes. The six symptom scores were summed to obtain the rhinoconjunctivitis symptoms score with range 0(best) to 18(worst). Baseline was set as 8 weeks before randomization as from V1 (Week -8) to V2 (Week 0). 11-12months' end evaluation period was set from V8(Week 44) to V9(Week 52). These two average rhinoconjunctivitis symptoms scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary. | Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52). |
| The Change From Baseline in Rhinoconjunctivitis Medication Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated. | Subjects were provided with open-labelled rescue medication to be used as needed for treatment of their rhinoconjunctivitis symptoms. Subjects reported their use of specific rescue medication via the patient diary cards. Scoring principles were applied to transform the number of rescue medication doses used into medication scores.The scores of all the medication used were summed to produce the daily rhinoconjunctivitis medication score range from 0 to 32. A lower medication score means the patient use less medication, and represent a better outcome; on the contrary, a higher medication score means the patient use more medication, and represent a worse outcome. Baseline was from V1 (Week -8) to V2 (Week 0). The end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and End) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days in diary. | Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52). |
| Measure | Description | Time Frame |
|---|---|---|
| The Change From Baseline in Rhinitis Symptom Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated. | Subjects were instructed by the investigator on how to complete symptom assessments and recorded the results in the patient diary cards on a daily basis. A total of 4 rhinitis symptoms were measured on a scale from 0-3 as follows: 0 = No symptoms.
Baseline was set as 8 weeks before randomization as from V1 (Week -8) to V2 (Week 0). 11-12months' end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhang Luo, Professor | Beijing Tongren Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| No.2, Chongwenmennei Street, Dongcheng District | Beijing | Beijing Municipality | 100730 | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | PANGRAMIN SLIT HDM MIX | Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months. |
| FG001 | Placebo | Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Full Analysis Set
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| ID | Title | Description |
|---|---|---|
| BG000 | PANGRAMIN SLIT HDM MIX | Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months. |
| BG001 | Placebo | Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Change From Baseline in Rhinoconjunctivitis Symptoms Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated. | Subjects completed symptom assessments and recorded the results in the patient diary cards on a daily basis. A total of six rhinoconjunctivitis symptoms were measured on a scale from 0-3 as follows: 0 = No symptoms.
The six symptoms are classified in 2 groups as follows: Nose symptoms: Runny nose, Blocked nose, Sneezing, Itchy nose; Eye symptoms: Gritty feeling/red/itchy eyes, Watery eyes. The six symptom scores were summed to obtain the rhinoconjunctivitis symptoms score with range 0(best) to 18(worst). Baseline was set as 8 weeks before randomization as from V1 (Week -8) to V2 (Week 0). 11-12months' end evaluation period was set from V8(Week 44) to V9(Week 52). These two average rhinoconjunctivitis symptoms scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary. | The analysis was performed in the Full Analysis Set. | Posted | Mean | Standard Deviation | units on a scale (Symptom Score) | Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52). |
All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PANGRAMIN SLIT HDM MIX | Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 15.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rhinopharyngitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vivian Wang, Sr. Medical Affairs Manager | ALK-Abelló A/S | 86 - 10 5166 8198 | Vivian.Wang@alk.net |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| Placebo | Biological | Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months. |
|
| Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52). |
| The Change From Baseline in Conjunctivitis Symptom Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated. | Subjects were instructed by the investigator on how to complete symptom assessments and recorded the results in the patient diary cards on a daily basis. A total of 2 conjunctivitis symptoms were measured on a scale from 0-3 as follows: 0 = No symptoms.
Baseline was set as 8 weeks before randomization as from V1 (Week -8) to V2 (Week 0). 11-12months' end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary. | Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52). |
| The Change From Baseline in Asthma Symptom Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated. | Subjects were instructed by the investigator on how to complete symptom assessments and recorded the results in the patient diary cards on a daily basis. A total of 4 Asthma symptoms were measured on a scale from 0-3 as follows: 0 = No symptoms.
Baseline was set as 8 weeks before randomization as from V1 (Week -8) to V2 (Week 0). 11-12months' end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary. | Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52). |
| Percentage of Healthy Days in This Study Between the Actively Treated Patients and the Placebo Treated. | A healthy day is a day without rhinoconjunctivitis symptoms and without any intake of rescue medication. Percentage of healthy days is the healthy days of subject in this study divided by the total study days. | Total study year |
| The Change From Baseline in Nasal Complain Scores on Visual Analog Scale at 11-12 Months Between the Actively Treated Patients and the Placebo Treated. | The average rhinoconjunctivitis VAS score (baseline to first year). The scale answers the question 'How have your nasal complaints been today?' from 0 = no symptoms to 10 = severe symptoms. The baseline VAS rhinoconjunctivitis score is the average value of VAS scores in V1 (Screen Visit, Week -8) and V2 (Randomization visit, Week 0), and Evaluation period (Months 11-12) VAS rhinoconjunctivitis score is the average value of VAS scores in V8 (Week 44) and V9 (Week 52). | Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52). |
| The Change From Baseline in Rhinitis Quality of Life Questionnaire at 12 Months Between the Actively Treated Patients and the Placebo Treated. | The baseline RQLQ value was collected in Visit 1 (Week -8) and the 12 months' RQLQ value was collected in Visit 9 (Week 52). The maximum value of RQLQ score is 168 and the minimum one is 0. The score is decreased as the life quality is better. | Visit 1 date(Week -8), Visit 9 date(Week 52). |
| Global Assessment of Rhinoconjunctivitis Symptom After Treatment Between the Actively Treated Patients and the Placebo Treated. | Comparing overall rhinoconjunctivitis symptoms at the end of study year Between the Actively Treated Patients and the Placebo Treated. | Visit 9 date, Week 52 |
| The Change From Baseline in Rhinitis Medication Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated. | Subjects were provided with open-labelled rescue medication to be used as needed for treatment of their Rhinitis symptoms. Subjects reported their use of specific rescue medication via the patient diary cards. Scoring principles were applied to transform the number of rescue medication doses used into medication scores. The scores of all the medication used were summed to produce the daily Rhinitis medication score range from 0 to 30. A lower medication score means the patient use less medication, and represent a better outcome; on the contrary, a higher medication score means the patient use more medication, and represent a worse outcome. Baseline was set as from V1 (Week -8) to V2 (Week 0). 11-12months' end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary. | Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52). |
| The Change From Baseline in Asthma Quality of Life Questionnaire at 12 Months Between the Actively Treated Patients and the Placebo Treated. | The baseline AQLQ value was collected in Visit 1 (Week -8) and the 12 months' RQLQ value was collected in Visit 9 (Week 52). The maximum value of RQLQ score is 217 and the minimum one is 0. The score is elevated as the life quality is better. | Visit 1 date(Week -8), Visit 9 date(Week 52). |
| The Change From Baseline in Asthma Medication Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated | Subjects were provided with open-labelled rescue medication to be used as needed for treatment of their Asthma symptoms. Subjects reported their use of specific rescue medication via the patient diary cards. Scoring principles were applied to transform the number of rescue medication doses used into medication scores. The scores of all the medication used were summed to produce the daily asthma medication score range from 0 to 32. A lower medication score means the patient use less medication, and represent a better outcome; on the contrary, a higher medication score means the patient use more medication, and represent a worse outcome. Baseline was set as from V1 (Week -8) to V2 (Week 0). 11-12months' end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months in evaluation period and divided with the days with diary. | Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
|
| Primary | The Change From Baseline in Rhinoconjunctivitis Medication Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated. | Subjects were provided with open-labelled rescue medication to be used as needed for treatment of their rhinoconjunctivitis symptoms. Subjects reported their use of specific rescue medication via the patient diary cards. Scoring principles were applied to transform the number of rescue medication doses used into medication scores.The scores of all the medication used were summed to produce the daily rhinoconjunctivitis medication score range from 0 to 32. A lower medication score means the patient use less medication, and represent a better outcome; on the contrary, a higher medication score means the patient use more medication, and represent a worse outcome. Baseline was from V1 (Week -8) to V2 (Week 0). The end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and End) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days in diary. | The analysis was performed in the Full Analysis Set. | Posted | Mean | Standard Deviation | units on a scale (Medication Score) | Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52). |
|
|
|
|
| Secondary | The Change From Baseline in Rhinitis Symptom Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated. | Subjects were instructed by the investigator on how to complete symptom assessments and recorded the results in the patient diary cards on a daily basis. A total of 4 rhinitis symptoms were measured on a scale from 0-3 as follows: 0 = No symptoms.
Baseline was set as 8 weeks before randomization as from V1 (Week -8) to V2 (Week 0). 11-12months' end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary. | The analysis was performed in the Full Analysis Set. | Posted | Mean | Standard Deviation | units on a scale (Symptom score) | Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52). |
|
|
|
|
| Secondary | The Change From Baseline in Conjunctivitis Symptom Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated. | Subjects were instructed by the investigator on how to complete symptom assessments and recorded the results in the patient diary cards on a daily basis. A total of 2 conjunctivitis symptoms were measured on a scale from 0-3 as follows: 0 = No symptoms.
Baseline was set as 8 weeks before randomization as from V1 (Week -8) to V2 (Week 0). 11-12months' end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary. | The analysis was performed in the Full Analysis Set. | Posted | Mean | Standard Deviation | units on a scale(Symptom score) | Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52). |
|
|
|
|
| Secondary | The Change From Baseline in Asthma Symptom Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated. | Subjects were instructed by the investigator on how to complete symptom assessments and recorded the results in the patient diary cards on a daily basis. A total of 4 Asthma symptoms were measured on a scale from 0-3 as follows: 0 = No symptoms.
Baseline was set as 8 weeks before randomization as from V1 (Week -8) to V2 (Week 0). 11-12months' end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary. | The analysis was performed in the Full Analysis Set. | Posted | Mean | Standard Deviation | units on a scale(Symptom score) | Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52). |
|
|
|
|
| Secondary | Percentage of Healthy Days in This Study Between the Actively Treated Patients and the Placebo Treated. | A healthy day is a day without rhinoconjunctivitis symptoms and without any intake of rescue medication. Percentage of healthy days is the healthy days of subject in this study divided by the total study days. | The analysis was performed in the Full Analysis Set. | Posted | Mean | Standard Deviation | Percentage of healthy days | Total study year |
|
|
|
|
| Secondary | The Change From Baseline in Nasal Complain Scores on Visual Analog Scale at 11-12 Months Between the Actively Treated Patients and the Placebo Treated. | The average rhinoconjunctivitis VAS score (baseline to first year). The scale answers the question 'How have your nasal complaints been today?' from 0 = no symptoms to 10 = severe symptoms. The baseline VAS rhinoconjunctivitis score is the average value of VAS scores in V1 (Screen Visit, Week -8) and V2 (Randomization visit, Week 0), and Evaluation period (Months 11-12) VAS rhinoconjunctivitis score is the average value of VAS scores in V8 (Week 44) and V9 (Week 52). | The analysis was performed in the Full Analysis Set. | Posted | Mean | Standard Deviation | units on a scale (VAS Score) | Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52). |
|
|
|
|
| Secondary | The Change From Baseline in Rhinitis Quality of Life Questionnaire at 12 Months Between the Actively Treated Patients and the Placebo Treated. | The baseline RQLQ value was collected in Visit 1 (Week -8) and the 12 months' RQLQ value was collected in Visit 9 (Week 52). The maximum value of RQLQ score is 168 and the minimum one is 0. The score is decreased as the life quality is better. | The analysis was performed in the Full Analysis Set. | Posted | Mean | Standard Deviation | units on a scale (RQLQ score) | Visit 1 date(Week -8), Visit 9 date(Week 52). |
|
|
|
|
| Secondary | Global Assessment of Rhinoconjunctivitis Symptom After Treatment Between the Actively Treated Patients and the Placebo Treated. | Comparing overall rhinoconjunctivitis symptoms at the end of study year Between the Actively Treated Patients and the Placebo Treated. | The analysis was performed in the Full Analysis Set. | Posted | Number | participants | Visit 9 date, Week 52 |
|
|
|
|
| Secondary | The Change From Baseline in Rhinitis Medication Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated. | Subjects were provided with open-labelled rescue medication to be used as needed for treatment of their Rhinitis symptoms. Subjects reported their use of specific rescue medication via the patient diary cards. Scoring principles were applied to transform the number of rescue medication doses used into medication scores. The scores of all the medication used were summed to produce the daily Rhinitis medication score range from 0 to 30. A lower medication score means the patient use less medication, and represent a better outcome; on the contrary, a higher medication score means the patient use more medication, and represent a worse outcome. Baseline was set as from V1 (Week -8) to V2 (Week 0). 11-12months' end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary. | The analysis was performed in the Full Analysis Set. | Posted | Mean | Standard Deviation | units on a scale(Medication score) | Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52). |
|
|
|
|
| Secondary | The Change From Baseline in Asthma Quality of Life Questionnaire at 12 Months Between the Actively Treated Patients and the Placebo Treated. | The baseline AQLQ value was collected in Visit 1 (Week -8) and the 12 months' RQLQ value was collected in Visit 9 (Week 52). The maximum value of RQLQ score is 217 and the minimum one is 0. The score is elevated as the life quality is better. | The analysis was performed in the Full Analysis Set. | Posted | Mean | Standard Deviation | units on a scale(AQLQ score) | Visit 1 date(Week -8), Visit 9 date(Week 52). |
|
|
|
|
| Secondary | The Change From Baseline in Asthma Medication Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated | Subjects were provided with open-labelled rescue medication to be used as needed for treatment of their Asthma symptoms. Subjects reported their use of specific rescue medication via the patient diary cards. Scoring principles were applied to transform the number of rescue medication doses used into medication scores. The scores of all the medication used were summed to produce the daily asthma medication score range from 0 to 32. A lower medication score means the patient use less medication, and represent a better outcome; on the contrary, a higher medication score means the patient use more medication, and represent a worse outcome. Baseline was set as from V1 (Week -8) to V2 (Week 0). 11-12months' end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months in evaluation period and divided with the days with diary. | The analysis was performed in the Full Analysis Set. | Posted | Mean | Standard Deviation | units on a scale(Medication score) | Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52). |
|
|
|
|
| 7 |
| 402 |
| 299 |
| 402 |
| EG001 | Placebo | Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months. | 3 | 200 | 140 | 200 |
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 15.0 | Non-systematic Assessment |
|
| Acute bronchial asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Left ureteral calculi | Surgical and medical procedures | MedDRA 15.0 | Non-systematic Assessment |
|
| Acute purulent tonsillitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Deflection of nasal septum | Surgical and medical procedures | MedDRA 15.0 | Non-systematic Assessment |
|
| Chronic hypertrophic rhinitis | Surgical and medical procedures | MedDRA 15.0 | Non-systematic Assessment |
|
| Thyroid adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Fever | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Oropharyngeal | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Erythra | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Oral hypoesthesia | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Dental ulcer | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Odontalgia | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Epigastric pain | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
Sponsor has the right to review and comment any manuscript within 30 days of receipt, but cannot prevent publications of findings. Sponsor will review the communications for accuracy (thus avoiding potential discrepancies with submissions to health authorities), verify that the confidential information is not being inadvertently divulged and provide any relevant supplementary information.
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fair |
|
| Worse |
|
| Not Done |
|