Trial Outcomes & Findings for Efficacy/ Safety of Omalizumab in Patients With Seasonal Allergic Asthma and Seasonal Allergic Rhinoconjunctivitis (NCT NCT00396409)
NCT ID: NCT00396409
Last Updated: 2017-03-30
Results Overview
The daily symptom load (low=0, high=unbounded) represents the daily combined asthma and rhinoconjunctivitis symptom severity scores plus the daily asthma rescue medication score based on patient diary entries. A higher score indicates a worse patient asthma condition. Symptoms (e.g. - difficulty breathing, cough, tightness of chest, sneezing, itchy nose, red eyes, etc.) were evaluated daily by the patient using a 4-point scale (0=no symptom, 1=mild, 2=moderate, 3=severe). Point values were assigned by specific rescue medication usage. The daily scores were averaged over pollen days by site.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
128 participants
Primary outcome timeframe
Recorded daily during the 2007 and 2008 pollen season
Results posted on
2017-03-30
Participant Flow
Participant milestones
| Measure |
Depigoid + Omalizumab
Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
|
Depigoid + Placebo
Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
|
|---|---|---|
|
Period 1 - 2007
STARTED
|
65
|
63
|
|
Period 1 - 2007
COMPLETED
|
62
|
57
|
|
Period 1 - 2007
NOT COMPLETED
|
3
|
6
|
|
Between Period 1 and Period 2
STARTED
|
62
|
57
|
|
Between Period 1 and Period 2
COMPLETED
|
59
|
55
|
|
Between Period 1 and Period 2
NOT COMPLETED
|
3
|
2
|
|
Period 2 - 2008
STARTED
|
59
|
55
|
|
Period 2 - 2008
COMPLETED
|
52
|
53
|
|
Period 2 - 2008
NOT COMPLETED
|
7
|
2
|
Reasons for withdrawal
| Measure |
Depigoid + Omalizumab
Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
|
Depigoid + Placebo
Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
|
|---|---|---|
|
Period 1 - 2007
Adverse Event
|
0
|
1
|
|
Period 1 - 2007
Lack of Efficacy
|
0
|
1
|
|
Period 1 - 2007
Withdrawal by Subject
|
1
|
1
|
|
Period 1 - 2007
Lost to Follow-up
|
2
|
3
|
|
Between Period 1 and Period 2
Withdrawal by Subject
|
3
|
2
|
|
Period 2 - 2008
Protocol Violation
|
1
|
0
|
|
Period 2 - 2008
Withdrawal by Subject
|
3
|
1
|
|
Period 2 - 2008
Lost to Follow-up
|
3
|
1
|
Baseline Characteristics
Efficacy/ Safety of Omalizumab in Patients With Seasonal Allergic Asthma and Seasonal Allergic Rhinoconjunctivitis
Baseline characteristics by cohort
| Measure |
Depigoid + Omalizumab
n=65 Participants
Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
|
Depigoid + Placebo
n=63 Participants
Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
2007
|
27.8 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
30.4 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
29.1 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Age, Continuous
2008 (N = 59/55/114)
|
27.6 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
30.1 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
28.8 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Age, Customized
<=18 years
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Age, Customized
Between 18 and 65 years
|
45 participants
n=5 Participants
|
40 participants
n=7 Participants
|
85 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Age, Customized
<= 18 years
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Age, Customized
>= 65 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Age, Customized
Participated in 2007 but not in 2008
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Sex/Gender, Customized
2007 Female
|
28 participants
n=5 Participants
|
27 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Sex/Gender, Customized
2007 Male
|
37 participants
n=5 Participants
|
36 participants
n=7 Participants
|
73 participants
n=5 Participants
|
|
Sex/Gender, Customized
2008 Female
|
24 participants
n=5 Participants
|
26 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Sex/Gender, Customized
2008 Male
|
35 participants
n=5 Participants
|
29 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
Sex/Gender, Customized
Participated in 2007 but not in 2008
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
65 participants
n=5 Participants
|
62 participants
n=7 Participants
|
127 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Participated in 2007 but not in 2008
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Recorded daily during the 2007 and 2008 pollen seasonPopulation: Intent-to-Treat (ITT). The complete analysis population who consisted of all patients that received at least one dose of study drug was used for all efficacy and safety evaluations in this extension period.
The daily symptom load (low=0, high=unbounded) represents the daily combined asthma and rhinoconjunctivitis symptom severity scores plus the daily asthma rescue medication score based on patient diary entries. A higher score indicates a worse patient asthma condition. Symptoms (e.g. - difficulty breathing, cough, tightness of chest, sneezing, itchy nose, red eyes, etc.) were evaluated daily by the patient using a 4-point scale (0=no symptom, 1=mild, 2=moderate, 3=severe). Point values were assigned by specific rescue medication usage. The daily scores were averaged over pollen days by site.
Outcome measures
| Measure |
Depigoid + Omalizumab
n=60 Participants
Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
|
Depigoid + Placebo
n=55 Participants
Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
|
|---|---|---|
|
Daily Symptom Load
2007
|
1.25 units on a scale
Standard Deviation 0.99
|
1.10 units on a scale
Standard Deviation 0.99
|
|
Daily Symptom Load
2008
|
1.32 units on a scale
Standard Deviation 1.74
|
0.97 units on a scale
Standard Deviation 1.02
|
SECONDARY outcome
Timeframe: Recorded daily during the 2007 and 2008 pollen seasonPopulation: Intent-to-Treat (ITT)
The symptom severity score was defined as the mean of the daily symptom severity scores (asthma symptoms during the day, asthma symptoms at night, rhinitis symptoms, and conjunctivitis symptoms) during the pollen season. The daily symptom severity scores were evaluated daily by the patient using a 4-point scale (0 = none (no symptom), 1 = mild, 2 = moderate, 3 = severe) and were recorded in a patient diary. The possible minimum value for the Asthma/Rhinoconjunctivitis Symptom Severity Score is 0, and the possible maximum value is 3. Higher values represent a worse outcome.
Outcome measures
| Measure |
Depigoid + Omalizumab
n=60 Participants
Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
|
Depigoid + Placebo
n=55 Participants
Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
|
|---|---|---|
|
Asthma/Rhinoconjunctivitis Symptom Severity Score
2007
|
0.55 units on a scale
Standard Deviation 0.40
|
0.55 units on a scale
Standard Deviation 0.38
|
|
Asthma/Rhinoconjunctivitis Symptom Severity Score
2008
|
0.54 units on a scale
Standard Deviation 0.42
|
0.50 units on a scale
Standard Deviation 0.37
|
SECONDARY outcome
Timeframe: Recorded daily during the 2007 and 2008 pollen seasonPopulation: Intent-to-Treat (ITT)
Asthma/Rhinoconjunctivitis rescue medication score is a component of symptom load. Patients were advised that between visits they could take short acting β-2 agonist rescue medication as initial rescue medication for symptoms of intercurrent bronchospasm. Patients were advised that between visits they could take rescue medication (systemic antihistamines) on an as-needed basis for symptoms of grass pollen allergic rhinoconjunctivitis. The symptom load and all its components were based on the patient's entries in their diaries.
Outcome measures
| Measure |
Depigoid + Omalizumab
n=60 Participants
Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
|
Depigoid + Placebo
n=55 Participants
Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
|
|---|---|---|
|
Asthma/Rhinoconjunctivitis Rescue Medication Score
2007
|
0.70 units on a scale
Standard Deviation 0.80
|
0.55 units on a scale
Standard Deviation 0.80
|
|
Asthma/Rhinoconjunctivitis Rescue Medication Score
2008
|
0.78 units on a scale
Standard Deviation 1.60
|
0.47 units on a scale
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: 52 Weeks (2007) and 104 Weeks (2008) after completion of core studyPopulation: Intent-to-Treat (ITT)
The investigator's assessment of the global evaluation of treatment effectiveness (GETE) using a five point scale, which evaluates change in asthma control/symptoms. GETE is scored as 1='excellent', 2='good', 3='moderate', 4='poor', 5='worsening' and (.)='missing').
Outcome measures
| Measure |
Depigoid + Omalizumab
n=60 Participants
Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
|
Depigoid + Placebo
n=55 Participants
Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
|
|---|---|---|
|
Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Investigator
2007: 1 = Excellent
|
10.00 percentage of participants
|
9.09 percentage of participants
|
|
Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Investigator
2007:2 = Good
|
70.00 percentage of participants
|
54.55 percentage of participants
|
|
Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Investigator
2007:3 = Moderate
|
16.67 percentage of participants
|
21.82 percentage of participants
|
|
Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Investigator
2007:4 = Poor
|
1.67 percentage of participants
|
14.55 percentage of participants
|
|
Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Investigator
2007:5 = Worsening
|
1.67 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Investigator
2007:(.) = Missing
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Investigator
2007:Responders (1+2)
|
80 percentage of participants
|
63.64 percentage of participants
|
|
Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Investigator
2008: 1 = Excellent
|
18.64 percentage of participants
|
14.55 percentage of participants
|
|
Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Investigator
2008:2 = Good
|
49.15 percentage of participants
|
30.91 percentage of participants
|
|
Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Investigator
2008:3 = Moderate
|
18.64 percentage of participants
|
43.64 percentage of participants
|
|
Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Investigator
2008:4 = Poor
|
6.78 percentage of participants
|
9.09 percentage of participants
|
|
Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Investigator
2008:5 = Worsening
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Investigator
2008:(.) = Missing
|
6.78 percentage of participants
|
1.82 percentage of participants
|
|
Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Investigator
2008:Responders (1+2)
|
67.79 percentage of participants
|
45.46 percentage of participants
|
SECONDARY outcome
Timeframe: 52 Weeks (2007) and 104 Weeks (2008) after completion of core studyPopulation: Intent-to-Treat (ITT)
The patient's assessment of the global evaluation of treatment effectiveness (GETE) using a five point scale, which evaluates change in asthma control/symptoms. GETE is scored as 1='excellent', 2='good', 3='moderate', 4='poor', 5='worsening' and (.)='missing').
Outcome measures
| Measure |
Depigoid + Omalizumab
n=60 Participants
Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
|
Depigoid + Placebo
n=55 Participants
Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
|
|---|---|---|
|
Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Patient
2007: 1 = Excellent
|
18.33 percentage of participants
|
7.27 percentage of participants
|
|
Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Patient
2007: 2 = Good
|
45.00 percentage of participants
|
50.91 percentage of participants
|
|
Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Patient
2007: 3 = Moderate
|
18.33 percentage of participants
|
18.18 percentage of participants
|
|
Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Patient
2007: 4 = Poor
|
10.00 percentage of participants
|
21.82 percentage of participants
|
|
Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Patient
2007: 5 = Worsening
|
1.67 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Patient
2007: (.) = Missing
|
6.67 percentage of participants
|
1.82 percentage of participants
|
|
Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Patient
2008: 1 = Excellent
|
13.56 percentage of participants
|
5.45 percentage of participants
|
|
Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Patient
2008: 2 = Good
|
45.76 percentage of participants
|
43.64 percentage of participants
|
|
Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Patient
2008: 3 = Moderate
|
25.42 percentage of participants
|
36.36 percentage of participants
|
|
Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Patient
2008: 4 = Poor
|
6.78 percentage of participants
|
9.09 percentage of participants
|
|
Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Patient
2008: 5 = Worsening
|
1.69 percentage of participants
|
1.82 percentage of participants
|
|
Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Patient
2008: (.) = Missing
|
6.78 percentage of participants
|
3.64 percentage of participants
|
SECONDARY outcome
Timeframe: 52 Weeks (2007) and 104 Weeks (2008) after completion of core studyPopulation: Intent-to-Treat (ITT)
The Asthma Control Questionnaire (ACQ) was developed and validated for assessing asthma symptom control in patients in clinical trials as well as for individuals in clinical practice. It is a simple questionnaire consisting of seven questions assessing symptoms, airway caliber and rescue β2-agonist use. It uses a 7-point scale. The possible minimum value is 1, the possible maximum value is 7. Higher values represent worse asthma control and quality of life, respectively.
Outcome measures
| Measure |
Depigoid + Omalizumab
n=60 Participants
Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
|
Depigoid + Placebo
n=55 Participants
Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
|
|---|---|---|
|
Asthma Control Questionnaire (ACQ)
2007
|
1.83 units on a scale
Standard Deviation 0.68
|
1.97 units on a scale
Standard Deviation 0.91
|
|
Asthma Control Questionnaire (ACQ)
2008
|
1.82 units on a scale
Standard Deviation 0.71
|
1.95 units on a scale
Standard Deviation 0.80
|
SECONDARY outcome
Timeframe: 52 Weeks (2007) and 104 Weeks (2008) after completion of core studyPopulation: Intent-to-Treat (ITT)
The Asthma Quality of Life Questionnaire (AQLQ) is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to patients with asthma. It consists of 4 domains (symptoms, emotions, exposure to environmental stimuli and activity limitation). Patients are asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale. The overall AQLQ score is the mean response to all 32 questions (low=1, high=7). Higher values represent better quality of life.
Outcome measures
| Measure |
Depigoid + Omalizumab
n=60 Participants
Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
|
Depigoid + Placebo
n=55 Participants
Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
|
|---|---|---|
|
Asthma Quality of Life Questionnaire (AQLQ)
2007
|
6.19 units on a scale
Standard Deviation 0.81
|
6.06 units on a scale
Standard Deviation 0.98
|
|
Asthma Quality of Life Questionnaire (AQLQ)
2008
|
6.22 units on a scale
Standard Deviation 0.77
|
6.21 units on a scale
Standard Deviation 0.74
|
SECONDARY outcome
Timeframe: 52 Weeks (2007) and 104 Weeks (2008) after completion of core studyPopulation: Intent-to-Treat (ITT)
The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) is a 28-item disease specific questionnaire designed to measure functional impairments that are most important to patients with rhinoconjunctivitis. It consists of 7 domains (activities, sleep, common complaints, practical problems, nasal symptoms, ocular symptoms, and emotions). Patients recall their experiences during the previous week and to score each item on a 7-point scale. The overall RQLQ score is the mean response to all 28 questions (low=1, high=7). Higher values represent worse quality of life.
Outcome measures
| Measure |
Depigoid + Omalizumab
n=60 Participants
Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
|
Depigoid + Placebo
n=55 Participants
Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
|
|---|---|---|
|
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
2007
|
2.07 units on a scale
Standard Deviation 0.86
|
2.08 units on a scale
Standard Deviation 0.95
|
|
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
2008
|
2.05 units on a scale
Standard Deviation 0.99
|
1.98 units on a scale
Standard Deviation 0.94
|
SECONDARY outcome
Timeframe: Baseline of core study and 52 Weeks (2007) and 104 Weeks (2008) after completion of core studyPopulation: Intent-to-Treat (ITT)
Both the AQLQ and RQLQ clinical differences were categorized as important, moderate, or meaningful improvement; no clinical change; meaningful, moderate, or important impairment. Clinically important differences in scores between any two assessments have been determined by the authors of the AQLQ and RQLQ. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and \> 1.5 as marked clinically important differences for any individual domain or for the overall summary score.
Outcome measures
| Measure |
Depigoid + Omalizumab
n=60 Participants
Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
|
Depigoid + Placebo
n=55 Participants
Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
|
|---|---|---|
|
Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline
2008 AQLQ: no clinical change
|
36 participants
|
28 participants
|
|
Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline
2007 AQLQ: important improvement
|
2 participants
|
3 participants
|
|
Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline
2007 AQLQ: moderate improvement
|
4 participants
|
3 participants
|
|
Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline
2007 AQLQ: meaningful improvement
|
8 participants
|
4 participants
|
|
Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline
2007 AQLQ: no clinical change
|
34 participants
|
27 participants
|
|
Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline
2007 AQLQ: meaningful impairment
|
5 participants
|
9 participants
|
|
Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline
2007 AQLQ: moderate impairment
|
2 participants
|
4 participants
|
|
Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline
2007 AQLQ: important impairment
|
4 participants
|
5 participants
|
|
Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline
2007 AQLQ: missing
|
1 participants
|
0 participants
|
|
Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline
2007 RQLQ: important improvement
|
4 participants
|
3 participants
|
|
Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline
2007 RQLQ: moderate improvement
|
4 participants
|
3 participants
|
|
Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline
2007 RQLQ: meaningful improvement
|
5 participants
|
4 participants
|
|
Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline
2007 RQLQ: no clinical change
|
27 participants
|
25 participants
|
|
Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline
2007 RQLQ: meaningful impairment
|
7 participants
|
10 participants
|
|
Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline
2007 RQLQ: moderate impairment
|
8 participants
|
5 participants
|
|
Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline
2007 RQLQ: important impairment
|
4 participants
|
5 participants
|
|
Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline
2007 RQLQ: missing
|
1 participants
|
0 participants
|
|
Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline
2008 AQLQ: important improvement
|
2 participants
|
4 participants
|
|
Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline
2008 AQLQ: moderate improvement
|
3 participants
|
2 participants
|
|
Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline
2008 AQLQ: meaningful improvement
|
6 participants
|
4 participants
|
|
Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline
2008 AQLQ: meaningful impairment
|
2 participants
|
9 participants
|
|
Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline
2008 AQLQ: moderate impairment
|
3 participants
|
4 participants
|
|
Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline
2008 AQLQ: important impairment
|
4 participants
|
3 participants
|
|
Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline
2008 AQLQ: missing
|
3 participants
|
1 participants
|
|
Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline
2008 RQLQ: important improvement
|
2 participants
|
3 participants
|
|
Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline
2008 RQLQ: moderate improvement
|
2 participants
|
2 participants
|
|
Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline
2008 RQLQ: meaningful improvement
|
7 participants
|
7 participants
|
|
Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline
2008 RQLQ: no clinical change
|
26 participants
|
22 participants
|
|
Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline
2008 RQLQ: meaningful impairment
|
9 participants
|
12 participants
|
|
Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline
2008 RQLQ: moderate impairment
|
6 participants
|
3 participants
|
|
Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline
2008 RQLQ: important impairment
|
4 participants
|
5 participants
|
|
Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline
2008 RQLQ: missing
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 52 Weeks (2007) and 104 Weeks (2008) after completion of core studyPopulation: Intent-to-Treat (ITT)
The Work Productivity and Activity Impairment questionnaire measures time missed from work, impairment of work and regular activities. It consists of 6 items. The outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. The minimum value is 0 (0 %), the maximum value is 1 (100%). The recall time is 1 week. For this study WPAI-AA was used defining the specific health problem as allergic asthma, which has been validated by the instrument owner.
Outcome measures
| Measure |
Depigoid + Omalizumab
n=60 Participants
Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
|
Depigoid + Placebo
n=55 Participants
Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
|
|---|---|---|
|
Work Productivity and Activity Impairment
2007: Work time missed due to asthma
|
0.00 units on a scale
Standard Deviation 0.01
|
0.01 units on a scale
Standard Deviation 0.04
|
|
Work Productivity and Activity Impairment
2007: Impairment while working due to asthma
|
0.17 units on a scale
Standard Deviation 0.20
|
0.09 units on a scale
Standard Deviation 0.16
|
|
Work Productivity and Activity Impairment
2007: Overall work impairment due to asthma
|
0.17 units on a scale
Standard Deviation 0.20
|
0.10 units on a scale
Standard Deviation 0.17
|
|
Work Productivity and Activity Impairment
2007: Activitiy impairment due to asthma
|
0.15 units on a scale
Standard Deviation 0.15
|
0.17 units on a scale
Standard Deviation 0.22
|
|
Work Productivity and Activity Impairment
2007Time in school activities missed due to asthma
|
0.00 units on a scale
Standard Deviation 0.00
|
0.01 units on a scale
Standard Deviation 0.02
|
|
Work Productivity and Activity Impairment
2007:Impairment in school activities due to asthma
|
0.04 units on a scale
Standard Deviation 0.09
|
0.11 units on a scale
Standard Deviation 0.18
|
|
Work Productivity and Activity Impairment
2007: Overall impairment/activities due to asthma
|
0.00 units on a scale
Standard Deviation 0.00
|
0.01 units on a scale
Standard Deviation 0.03
|
|
Work Productivity and Activity Impairment
2008: Work time missed due to asthma
|
0.00 units on a scale
Standard Deviation 0.01
|
0.04 units on a scale
Standard Deviation 0.18
|
|
Work Productivity and Activity Impairment
2008: Impairment while working due to asthma
|
0.11 units on a scale
Standard Deviation 0.13
|
0.10 units on a scale
Standard Deviation 0.16
|
|
Work Productivity and Activity Impairment
2008: Overall work impairment due to asthma
|
0.11 units on a scale
Standard Deviation 0.14
|
0.10 units on a scale
Standard Deviation 0.16
|
|
Work Productivity and Activity Impairment
2008: Activitiy impairment due to asthma
|
0.16 units on a scale
Standard Deviation 0.18
|
0.15 units on a scale
Standard Deviation 0.19
|
|
Work Productivity and Activity Impairment
2008Time in school activities missed due to asthma
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Work Productivity and Activity Impairment
2008:Impairment in school activities due to asthma
|
0.05 units on a scale
Standard Deviation 0.06
|
0.14 units on a scale
Standard Deviation 0.30
|
|
Work Productivity and Activity Impairment
2008: Overall impairment/activities due to asthma
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Assist during 2007 and 2008 pollen seasonPopulation: Intent-to-Treat (ITT)
The spirometric parameter Forced Expiratory Volume in One Second (FEV1) was measured during grass pollen season before each injection of Depigoid.
Outcome measures
| Measure |
Depigoid + Omalizumab
n=60 Participants
Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
|
Depigoid + Placebo
n=55 Participants
Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
|
|---|---|---|
|
Lung Function as Assessed by Forced Expiratory Volume in One Second (FEV1)
2007: FEV1 (best test)
|
3886 milliliters (mL)
Standard Deviation 740
|
3661 milliliters (mL)
Standard Deviation 720
|
|
Lung Function as Assessed by Forced Expiratory Volume in One Second (FEV1)
2008: FEV1 (best test)
|
3814 milliliters (mL)
Standard Deviation 721
|
3574 milliliters (mL)
Standard Deviation 691
|
SECONDARY outcome
Timeframe: Assist during 2007 and 2008 pollen seasonPopulation: Intent-to-Treat (ITT)
The spirometric parameter Peak Expiratory Flow (PEF) was measured during grass pollen season before each injection of Depigoid. PEF was collected in the patient diary at seven days after visit 22, 23 and 24 as well as 35, 36 and 37. For analyzing purposes these data were averaged after the respective visits. Missing PEF-values from the patient diary were not replaced.
Outcome measures
| Measure |
Depigoid + Omalizumab
n=60 Participants
Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
|
Depigoid + Placebo
n=55 Participants
Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
|
|---|---|---|
|
Lung Function as Assessed by Peak Expiratory Flow (PEF)
2007: PEF (V23 or 36)
|
465.6 liters per minute (L/min)
Standard Deviation 111.5
|
441.0 liters per minute (L/min)
Standard Deviation 111.8
|
|
Lung Function as Assessed by Peak Expiratory Flow (PEF)
2008: PEF (V23 or 36)
|
463.9 liters per minute (L/min)
Standard Deviation 113.2
|
446.1 liters per minute (L/min)
Standard Deviation 116.4
|
Adverse Events
Depigoid + Omalizumab 2007
Serious events: 2 serious events
Other events: 36 other events
Deaths: 0 deaths
Depigoid + Omalizumab 2008
Serious events: 5 serious events
Other events: 32 other events
Deaths: 0 deaths
Depigoid + Placebo 2007
Serious events: 2 serious events
Other events: 34 other events
Deaths: 0 deaths
Depigoid + Placebo 2008
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Depigoid + Omalizumab 2007
n=65 participants at risk
Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
|
Depigoid + Omalizumab 2008
n=59 participants at risk
Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
|
Depigoid + Placebo 2007
n=63 participants at risk
Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
|
Depigoid + Placebo 2008
n=55 participants at risk
Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
|
|---|---|---|---|---|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/65
|
0.00%
0/59
|
1.6%
1/63
|
0.00%
0/55
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/65
|
1.7%
1/59
|
0.00%
0/63
|
0.00%
0/55
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/65
|
1.7%
1/59
|
0.00%
0/63
|
0.00%
0/55
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/65
|
1.7%
1/59
|
0.00%
0/63
|
0.00%
0/55
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/65
|
0.00%
0/59
|
0.00%
0/63
|
1.8%
1/55
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/65
|
1.7%
1/59
|
0.00%
0/63
|
0.00%
0/55
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/65
|
1.7%
1/59
|
0.00%
0/63
|
0.00%
0/55
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.5%
1/65
|
1.7%
1/59
|
0.00%
0/63
|
0.00%
0/55
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/65
|
0.00%
0/59
|
1.6%
1/63
|
0.00%
0/55
|
|
Nervous system disorders
Syncope
|
0.00%
0/65
|
1.7%
1/59
|
0.00%
0/63
|
0.00%
0/55
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
1/65
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/55
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/65
|
1.7%
1/59
|
0.00%
0/63
|
0.00%
0/55
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/65
|
0.00%
0/59
|
1.6%
1/63
|
0.00%
0/55
|
|
Vascular disorders
Hypotension
|
0.00%
0/65
|
1.7%
1/59
|
0.00%
0/63
|
0.00%
0/55
|
Other adverse events
| Measure |
Depigoid + Omalizumab 2007
n=65 participants at risk
Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
|
Depigoid + Omalizumab 2008
n=59 participants at risk
Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
|
Depigoid + Placebo 2007
n=63 participants at risk
Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
|
Depigoid + Placebo 2008
n=55 participants at risk
Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
|
|---|---|---|---|---|
|
Eye disorders
Conjunctivitis allergic
|
3.1%
2/65
|
0.00%
0/59
|
6.3%
4/63
|
3.6%
2/55
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/65
|
0.00%
0/59
|
1.6%
1/63
|
5.5%
3/55
|
|
General disorders
Injection site reaction
|
16.9%
11/65
|
8.5%
5/59
|
15.9%
10/63
|
14.5%
8/55
|
|
General disorders
Pyrexia
|
0.00%
0/65
|
1.7%
1/59
|
0.00%
0/63
|
5.5%
3/55
|
|
Immune system disorders
Hypersensitivity
|
4.6%
3/65
|
5.1%
3/59
|
3.2%
2/63
|
1.8%
1/55
|
|
Infections and infestations
Bronchitis
|
9.2%
6/65
|
5.1%
3/59
|
4.8%
3/63
|
9.1%
5/55
|
|
Infections and infestations
Gastroenteritis
|
3.1%
2/65
|
0.00%
0/59
|
0.00%
0/63
|
5.5%
3/55
|
|
Infections and infestations
Nasopharyngitis
|
29.2%
19/65
|
32.2%
19/59
|
22.2%
14/63
|
21.8%
12/55
|
|
Infections and infestations
Pharyngitis
|
1.5%
1/65
|
0.00%
0/59
|
0.00%
0/63
|
5.5%
3/55
|
|
Infections and infestations
Rhinitis
|
6.2%
4/65
|
1.7%
1/59
|
11.1%
7/63
|
3.6%
2/55
|
|
Infections and infestations
Sinusitis
|
4.6%
3/65
|
10.2%
6/59
|
3.2%
2/63
|
7.3%
4/55
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/65
|
5.1%
3/59
|
6.3%
4/63
|
3.6%
2/55
|
|
Nervous system disorders
Headache
|
3.1%
2/65
|
6.8%
4/59
|
3.2%
2/63
|
7.3%
4/55
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
6.2%
4/65
|
0.00%
0/59
|
7.9%
5/63
|
10.9%
6/55
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
5/65
|
10.2%
6/59
|
6.3%
4/63
|
3.6%
2/55
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
6.2%
4/65
|
1.7%
1/59
|
7.9%
5/63
|
5.5%
3/55
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER