Trial Outcomes & Findings for Subcutaneous Immunotherapy in Patients Sensitized to Dermatophagoides Pteronyssinus (DPT) (NCT NCT01489020)
NCT ID: NCT01489020
Last Updated: 2019-05-06
Results Overview
The primary end points were the number of ARs and the severity of local and systemic ARs (SARs) to SCIT administration. Proportions were compared between study arms. The tolerability of SCIT was evaluated by early and late local reactions (i.e., local swelling and redness) and systemic reactions after each injection (any symptoms from organs distant from the location of the injection). Reactions were classified depending on the severity and onset of the reaction, according to the EAACI classification (Alvarez-Cuesta 2006).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
From informed consent signature (V0) until the end of patient participation in the study (depending on the treatment assigned between 4 and 8 weeks )
Results posted on
2019-05-06
Participant Flow
Participant milestones
| Measure |
Group A Active
6 administrations and 5 weeks duration
1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals
2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.
subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)
|
Group A Placebo
6 administrations and 5 weeks duration
1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals
2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.
subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)
|
Group B Active
8 administrations and 7 weeks duration
1. Vial 1: 0.2 ml at 1 week intervals
2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals
3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals
subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)
|
Group B Placebo
8 administrations and 7 weeks duration
1. Vial 1: 0.2 ml at 1 week intervals
2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals
3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals
subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)
|
Group C Active
8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.
1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval
2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval
3. Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval
4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval
subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)
|
Group C Placebo
8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.
1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval
2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval
3. Week 3: vial 3 - 2 dose of 0.1 ml with 30 minute interval
4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval
subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
4
|
12
|
4
|
12
|
4
|
|
Overall Study
COMPLETED
|
11
|
4
|
9
|
4
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
3
|
0
|
6
|
0
|
Reasons for withdrawal
| Measure |
Group A Active
6 administrations and 5 weeks duration
1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals
2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.
subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)
|
Group A Placebo
6 administrations and 5 weeks duration
1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals
2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.
subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)
|
Group B Active
8 administrations and 7 weeks duration
1. Vial 1: 0.2 ml at 1 week intervals
2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals
3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals
subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)
|
Group B Placebo
8 administrations and 7 weeks duration
1. Vial 1: 0.2 ml at 1 week intervals
2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals
3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals
subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)
|
Group C Active
8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.
1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval
2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval
3. Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval
4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval
subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)
|
Group C Placebo
8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.
1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval
2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval
3. Week 3: vial 3 - 2 dose of 0.1 ml with 30 minute interval
4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval
subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
3
|
0
|
3
|
0
|
|
Overall Study
Concomitant disease
|
0
|
0
|
0
|
0
|
3
|
0
|
Baseline Characteristics
Subcutaneous Immunotherapy in Patients Sensitized to Dermatophagoides Pteronyssinus (DPT)
Baseline characteristics by cohort
| Measure |
Group A Active
n=12 Participants
6 administrations and 5 weeks duration
1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals
2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.
subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo
|
Group B Active
n=12 Participants
8 administrations and 7 weeks duration
1. Vial 1: 0.2 ml at 1 week intervals
2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals
3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals
subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo
|
Group C Active
n=12 Participants
8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.
1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval
2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval
3. Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval
4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval
subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo
|
Group A Placebo
n=4 Participants
6 administrations and 5 weeks duration
1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals
2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.
Subcutaneous depot placebo
|
Group B Placebo
n=4 Participants
8 administrations and 7 weeks duration
1. Vial 1: 0.2 ml at 1 week intervals
2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals
3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals
subcutaneous depot placebo
|
Group C Placebo
n=4 Participants
8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.
1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval
2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval
3. Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval
4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval
subcutaneous depot placebo
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
31.66 years
STANDARD_DEVIATION 8.93 • n=5 Participants
|
30.88 years
STANDARD_DEVIATION 9.77 • n=7 Participants
|
31.80 years
STANDARD_DEVIATION 8.85 • n=5 Participants
|
33.93 years
STANDARD_DEVIATION 9.49 • n=4 Participants
|
33.93 years
STANDARD_DEVIATION 9.49 • n=21 Participants
|
33.93 years
STANDARD_DEVIATION 9.49 • n=8 Participants
|
32.68 years
STANDARD_DEVIATION 9.34 • n=8 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
24 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
24 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From informed consent signature (V0) until the end of patient participation in the study (depending on the treatment assigned between 4 and 8 weeks )The primary end points were the number of ARs and the severity of local and systemic ARs (SARs) to SCIT administration. Proportions were compared between study arms. The tolerability of SCIT was evaluated by early and late local reactions (i.e., local swelling and redness) and systemic reactions after each injection (any symptoms from organs distant from the location of the injection). Reactions were classified depending on the severity and onset of the reaction, according to the EAACI classification (Alvarez-Cuesta 2006).
Outcome measures
| Measure |
Group A Active
n=12 Participants
6 administrations and 5 weeks duration
1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals
2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.
subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo
|
Group B Active
n=12 Participants
8 administrations and 7 weeks duration
1. Vial 1: 0.2 ml at 1 week intervals
2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals
3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals
subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo
|
Group C Active
n=12 Participants
8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.
1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval
2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval
3. Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval
4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval
subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo
|
Group A Placebo
n=4 Participants
6 administrations and 5 weeks duration
1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals
2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.
subcutaneous depot placebo
|
Group B Placebo
n=4 Participants
8 administrations and 7 weeks duration
1. Vial 1: 0.2 ml at 1 week intervals
2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals
3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals
subcutaneous depot placebo
|
Group C Placebo
n=4 Participants
8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.
1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval
2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval
3. Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval
4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval
subcutaneous depot placebo
|
|---|---|---|---|---|---|---|
|
Number and Seriousness of Both Local and Systemic Adverse Reactions
Local adverse reactions number
|
2 adverse reactions number
|
1 adverse reactions number
|
0 adverse reactions number
|
1 adverse reactions number
|
1 adverse reactions number
|
0 adverse reactions number
|
|
Number and Seriousness of Both Local and Systemic Adverse Reactions
Systemic adverse reactions number
|
4 adverse reactions number
|
6 adverse reactions number
|
4 adverse reactions number
|
0 adverse reactions number
|
1 adverse reactions number
|
1 adverse reactions number
|
SECONDARY outcome
Timeframe: Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)Changes on immunoglobulin level determinations (specific IgE, IgG and IgG4) from basal visit to final visit and changes in mean wheal area in prick test dose response from basal visit to final visit, active versus placebo.
Outcome measures
| Measure |
Group A Active
n=11 Participants
6 administrations and 5 weeks duration
1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals
2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.
subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo
|
Group B Active
n=4 Participants
8 administrations and 7 weeks duration
1. Vial 1: 0.2 ml at 1 week intervals
2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals
3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals
subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo
|
Group C Active
n=9 Participants
8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.
1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval
2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval
3. Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval
4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval
subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo
|
Group A Placebo
n=4 Participants
6 administrations and 5 weeks duration
1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals
2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.
subcutaneous depot placebo
|
Group B Placebo
n=6 Participants
8 administrations and 7 weeks duration
1. Vial 1: 0.2 ml at 1 week intervals
2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals
3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals
subcutaneous depot placebo
|
Group C Placebo
n=4 Participants
8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.
1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval
2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval
3. Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval
4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval
subcutaneous depot placebo
|
|---|---|---|---|---|---|---|
|
Immunoglobulin Levels (IgE Specific) Active Versus Placebo
|
0.0750 ng/mL
Standard Deviation 0.393
|
-0.0055 ng/mL
Standard Deviation 0.013
|
0.1709 ng/mL
Standard Deviation 0.274
|
-0.1445 ng/mL
Standard Deviation 0.639
|
-0.0398 ng/mL
Standard Deviation 0.507
|
0.0395 ng/mL
Standard Deviation 0.039
|
SECONDARY outcome
Timeframe: Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)Changes on immunoglobulin level determinations (IgG) from basal visit to final visit and changes in mean wheal area in prick test dose response from basal visit to final visit, active versus placebo.
Outcome measures
| Measure |
Group A Active
n=11 Participants
6 administrations and 5 weeks duration
1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals
2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.
subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo
|
Group B Active
n=4 Participants
8 administrations and 7 weeks duration
1. Vial 1: 0.2 ml at 1 week intervals
2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals
3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals
subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo
|
Group C Active
n=9 Participants
8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.
1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval
2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval
3. Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval
4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval
subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo
|
Group A Placebo
n=4 Participants
6 administrations and 5 weeks duration
1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals
2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.
subcutaneous depot placebo
|
Group B Placebo
n=6 Participants
8 administrations and 7 weeks duration
1. Vial 1: 0.2 ml at 1 week intervals
2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals
3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals
subcutaneous depot placebo
|
Group C Placebo
n=4 Participants
8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.
1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval
2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval
3. Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval
4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval
subcutaneous depot placebo
|
|---|---|---|---|---|---|---|
|
Immunoglobulin Levels (IgG Total) Active Versus Placebo
|
-0.8813 ng/mL
Standard Deviation 0.484
|
-0.0405 ng/mL
Standard Deviation 0.097
|
-0.9589 ng/mL
Standard Deviation 0.536
|
-0.0953 ng/mL
Standard Deviation 0.137
|
-0.4918 ng/mL
Standard Deviation 0.389
|
-0.0425 ng/mL
Standard Deviation 0.090
|
SECONDARY outcome
Timeframe: Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)Changes on immunoglobulin level determinations (IgG4) from basal visit to final visit and changes in mean wheal area in prick test dose response from basal visit to final visit, active versus placebo.
Outcome measures
| Measure |
Group A Active
n=11 Participants
6 administrations and 5 weeks duration
1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals
2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.
subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo
|
Group B Active
n=4 Participants
8 administrations and 7 weeks duration
1. Vial 1: 0.2 ml at 1 week intervals
2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals
3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals
subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo
|
Group C Active
n=9 Participants
8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.
1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval
2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval
3. Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval
4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval
subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo
|
Group A Placebo
n=4 Participants
6 administrations and 5 weeks duration
1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals
2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.
subcutaneous depot placebo
|
Group B Placebo
n=6 Participants
8 administrations and 7 weeks duration
1. Vial 1: 0.2 ml at 1 week intervals
2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals
3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals
subcutaneous depot placebo
|
Group C Placebo
n=4 Participants
8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.
1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval
2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval
3. Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval
4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval
subcutaneous depot placebo
|
|---|---|---|---|---|---|---|
|
Immunoglobulin Levels (IgG 4) Active Versus Placebo
|
-1.0878 ng/mL
Standard Deviation 0.770
|
0.0838 ng/mL
Standard Deviation 0.518
|
-1.2885 ng/mL
Standard Deviation 0.844
|
0.0770 ng/mL
Standard Deviation 0.162
|
-0.8243 ng/mL
Standard Deviation 0.663
|
0.0580 ng/mL
Standard Deviation 0.039
|
Adverse Events
Group A Active
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Group B Active
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Group C Active
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Group A Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group B Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group C Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A Active
n=12 participants at risk
6 administrations and 5 weeks duration
1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals
2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.
subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo
|
Group B Active
n=12 participants at risk
8 administrations and 7 weeks duration
1. Vial 1: 0.2 ml at 1 week intervals
2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals
3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals
subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo
|
Group C Active
n=12 participants at risk
8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.
1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval
2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval
3. Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval
4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval
subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo
|
Group A Placebo
n=4 participants at risk
6 administrations and 5 weeks duration
1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals
2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.
subcutaneous depot placebo
|
Group B Placebo
n=4 participants at risk
8 administrations and 7 weeks duration
1. Vial 1: 0.2 ml at 1 week intervals
2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals
3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals
subcutaneous depot placebo
|
Group C Placebo
n=4 participants at risk
8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.
1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval
2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval
3. Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval
4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval
subcutaneous depot placebo
|
|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Otitis
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
|
Gastrointestinal disorders
pyrosis
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Facial edema
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
urticaria
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Edema in upper extremities
|
0.00%
0/12
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
broncoconstriction
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
16.7%
2/12 • Number of events 2
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/12
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
|
Immune system disorders
allergic rhinoconjunctivitis
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
Other adverse events
| Measure |
Group A Active
n=12 participants at risk
6 administrations and 5 weeks duration
1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals
2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.
subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo
|
Group B Active
n=12 participants at risk
8 administrations and 7 weeks duration
1. Vial 1: 0.2 ml at 1 week intervals
2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals
3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals
subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo
|
Group C Active
n=12 participants at risk
8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.
1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval
2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval
3. Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval
4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval
subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo
|
Group A Placebo
n=4 participants at risk
6 administrations and 5 weeks duration
1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals
2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.
subcutaneous depot placebo
|
Group B Placebo
n=4 participants at risk
8 administrations and 7 weeks duration
1. Vial 1: 0.2 ml at 1 week intervals
2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals
3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals
subcutaneous depot placebo
|
Group C Placebo
n=4 participants at risk
8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.
1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval
2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval
3. Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval
4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval
subcutaneous depot placebo
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
cephalea
|
25.0%
3/12 • Number of events 7
|
41.7%
5/12 • Number of events 12
|
33.3%
4/12 • Number of events 7
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
|
Infections and infestations
Cold
|
41.7%
5/12 • Number of events 5
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
|
General disorders
alterations injection site
|
41.7%
5/12 • Number of events 12
|
58.3%
7/12 • Number of events 16
|
41.7%
5/12 • Number of events 20
|
25.0%
1/4 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
Additional Information
Dr. M Cruz Gómez project manager of Roxall Medicina España S.A.
Roxall Medicina España S.A.
Phone: +34 944438000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place