Trial Outcomes & Findings for Biomarker-based Cockroach Sublingual Immunotherapy Study (BioCSI) (NCT NCT00829985)
NCT ID: NCT00829985
Last Updated: 2017-03-21
Results Overview
Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin E (IgE) vs. post-baseline German cockroach-specific serum IgE. This result is an indicator of immune modulation over time, however its clinical significance is unclear.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
54 participants
Primary outcome timeframe
Baseline through 6-months of treatment
Results posted on
2017-03-21
Participant Flow
Four National Institute of Allergy and Infectious Diseases (NIAID) Inner-City Asthma Consortium (ICAC) sites in the United States recruited the targeted number of study participants who fulfilled entry criteria between January and June 2009.
Participant milestones
| Measure |
Glycerinated German Cockroach Allergenic Extract
Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume \[w/v\]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
|
Placebo
Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume \[w/v\]) was achieved.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
26
|
|
Overall Study
COMPLETED
|
19
|
22
|
|
Overall Study
NOT COMPLETED
|
9
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Biomarker-based Cockroach Sublingual Immunotherapy Study (BioCSI)
Baseline characteristics by cohort
| Measure |
Glycerinated German Cockroach Allergenic Extract
n=28 Participants
Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume \[w/v\]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
|
Placebo
n=26 Participants
Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume \[w/v\]) was achieved.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31 years
STANDARD_DEVIATION 9.9 • n=99 Participants
|
33 years
STANDARD_DEVIATION 11.4 • n=107 Participants
|
32 years
STANDARD_DEVIATION 10.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=99 Participants
|
26 participants
n=107 Participants
|
54 participants
n=206 Participants
|
|
German Cockroach-Specific Serum IgE Levels
|
1.9 kU/L
n=99 Participants
|
2.9 kU/L
n=107 Participants
|
2.0 kU/L
n=206 Participants
|
|
German Cockroach-Specific Serum Immunoglobulin Subclass 4 (IgG4) Levels
|
0.19 mg/mL
n=99 Participants
|
0.08 mg/mL
n=107 Participants
|
0.09 mg/mL
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline through 6-months of treatmentPopulation: Intent-to-treat
Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin E (IgE) vs. post-baseline German cockroach-specific serum IgE. This result is an indicator of immune modulation over time, however its clinical significance is unclear.
Outcome measures
| Measure |
Glycerinated German Cockroach Allergenic Extract
n=23 Participants
Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume \[w/v\]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
|
Placebo
n=25 Participants
Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume \[w/v\]) was achieved.
|
|---|---|---|
|
Difference in German Cockroach-Specific Serum IgE Over Time
|
2.16 Ratio
Interval 1.81 to 2.57
|
1.12 Ratio
Interval 0.95 to 1.33
|
SECONDARY outcome
Timeframe: Baseline through 6-months of treatmentPopulation: Intent-to-treat
Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin subclass 4 (IgG4) vs. post-baseline German cockroach-specific serum IgG4. This ratio is an indicator of immune modulation, however its clinical significance is unclear.
Outcome measures
| Measure |
Glycerinated German Cockroach Allergenic Extract
n=23 Participants
Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume \[w/v\]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
|
Placebo
n=25 Participants
Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume \[w/v\]) was achieved.
|
|---|---|---|
|
Difference in German Cockroach-Specific Serum IgG4 Over Time
|
1.06 Ratio
Interval 0.95 to 1.17
|
0.93 Ratio
Interval 0.83 to 1.03
|
SECONDARY outcome
Timeframe: Baseline through 6-months of treatmentPopulation: Intent-to-treat
Outcome is the change in mean IgE fragment antibody binding (FAB) activity, baseline to post-baseline. Serum from sensitized donor incubated with 30 micrograms/mL of cockroach allergen extract in presence or absence of equal volume of sera from study participants to assess allergen-IgE binding. (Presence of sera from those who previously received allergen-specific immunotherapy, viz., study participants post-baseline, expected to inhibit allergen-IgE complex binding.) This change is an indicator of immune modulation, however its clinical significance is unclear.
Outcome measures
| Measure |
Glycerinated German Cockroach Allergenic Extract
n=23 Participants
Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume \[w/v\]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
|
Placebo
n=25 Participants
Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume \[w/v\]) was achieved.
|
|---|---|---|
|
Change in IgE Fragment Antibody Binding (FAB) Activity (30 Micrograms/mL Cockroach Allergen Extract)
|
4.7 Percent antibody binding
Interval -1.72 to 11.28
|
0.7 Percent antibody binding
Interval -5.56 to 6.87
|
SECONDARY outcome
Timeframe: Baseline through 6-months of treatmentPopulation: Intent-to-treat
Outcome is the change in mean IgE fragment antibody binding (FAB) activity, baseline to post-baseline. Serum from sensitized donor incubated with 60 micrograms/mL of cockroach allergen extract in presence or absence of equal volume of sera from study participants to assess allergen-IgE binding. (Presence of sera from those who previously received allergen-specific immunotherapy, viz., study participants post-baseline, expected to inhibit allergen-IgE complex binding.) This change is an indicator of immune modulation, however its clinical significance is unclear.
Outcome measures
| Measure |
Glycerinated German Cockroach Allergenic Extract
n=23 Participants
Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume \[w/v\]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
|
Placebo
n=25 Participants
Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume \[w/v\]) was achieved.
|
|---|---|---|
|
Change in IgE Fragment Antibody Binding (FAB) Activity (60 Micrograms/mL Cockroach Allergen Extract)
|
4.0 Percent antibody binding
Interval -0.38 to 8.45
|
-1.3 Percent antibody binding
Interval -5.6 to 2.94
|
SECONDARY outcome
Timeframe: Participant enrollment to end of study (up to 6 months post-baseline)Population: Safety population
Percent of participants who experienced at least one adverse event
Outcome measures
| Measure |
Glycerinated German Cockroach Allergenic Extract
n=28 Participants
Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume \[w/v\]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
|
Placebo
n=26 Participants
Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume \[w/v\]) was achieved.
|
|---|---|---|
|
Percent of Participants With the Occurrence of Adverse Events (AE)
|
93 percentage of population
|
85 percentage of population
|
Adverse Events
Glycerinated German Cockroach Allergenic Extract
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Glycerinated German Cockroach Allergenic Extract
n=28 participants at risk
Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume \[w/v\]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
|
Placebo
n=26 participants at risk
Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume \[w/v\]) was achieved.
|
|---|---|---|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/28
|
3.8%
1/26 • Number of events 1
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/28
|
3.8%
1/26 • Number of events 1
|
Other adverse events
| Measure |
Glycerinated German Cockroach Allergenic Extract
n=28 participants at risk
Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume \[w/v\]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
|
Placebo
n=26 participants at risk
Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume \[w/v\]) was achieved.
|
|---|---|---|
|
Ear and labyrinth disorders
Ear pruritus
|
25.0%
7/28 • Number of events 12
|
38.5%
10/26 • Number of events 11
|
|
Eye disorders
Eye pruritus
|
17.9%
5/28 • Number of events 5
|
15.4%
4/26 • Number of events 4
|
|
Eye disorders
Lacrimation increased
|
14.3%
4/28 • Number of events 5
|
11.5%
3/26 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal discomfort
|
7.1%
2/28 • Number of events 3
|
0.00%
0/26
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
2/28 • Number of events 2
|
7.7%
2/26 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.3%
4/28 • Number of events 4
|
15.4%
4/26 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
7/28 • Number of events 9
|
15.4%
4/26 • Number of events 9
|
|
Gastrointestinal disorders
Nausea
|
7.1%
2/28 • Number of events 2
|
15.4%
4/26 • Number of events 9
|
|
Gastrointestinal disorders
Oral mucosal erythema
|
7.1%
2/28 • Number of events 3
|
3.8%
1/26 • Number of events 1
|
|
Gastrointestinal disorders
Oral pruritus
|
25.0%
7/28 • Number of events 18
|
30.8%
8/26 • Number of events 11
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
4/28 • Number of events 6
|
7.7%
2/26 • Number of events 2
|
|
General disorders
Adverse drug reaction
|
32.1%
9/28 • Number of events 12
|
26.9%
7/26 • Number of events 9
|
|
General disorders
Chest discomfort
|
7.1%
2/28 • Number of events 2
|
7.7%
2/26 • Number of events 2
|
|
General disorders
Pyrexia
|
3.6%
1/28 • Number of events 1
|
7.7%
2/26 • Number of events 2
|
|
Immune system disorders
Multiple allergies
|
7.1%
2/28 • Number of events 3
|
3.8%
1/26 • Number of events 2
|
|
Immune system disorders
Seasonal allergy
|
7.1%
2/28 • Number of events 3
|
3.8%
1/26 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
3.6%
1/28 • Number of events 1
|
7.7%
2/26 • Number of events 2
|
|
Infections and infestations
Pharyngitis
|
7.1%
2/28 • Number of events 2
|
3.8%
1/26 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
2/28 • Number of events 2
|
3.8%
1/26 • Number of events 1
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/28
|
7.7%
2/26 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
2/28 • Number of events 2
|
0.00%
0/26
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.1%
2/28 • Number of events 3
|
0.00%
0/26
|
|
Nervous system disorders
Headache
|
7.1%
2/28 • Number of events 3
|
3.8%
1/26 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.6%
8/28 • Number of events 10
|
0.00%
0/26
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.1%
2/28 • Number of events 2
|
11.5%
3/26 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
25.0%
7/28 • Number of events 9
|
11.5%
3/26 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
25.0%
7/28 • Number of events 8
|
3.8%
1/26 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.1%
2/28 • Number of events 2
|
3.8%
1/26 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
17.9%
5/28 • Number of events 5
|
15.4%
4/26 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
14.3%
4/28 • Number of events 4
|
0.00%
0/26
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
42.9%
12/28 • Number of events 16
|
46.2%
12/26 • Number of events 21
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
10.7%
3/28 • Number of events 3
|
3.8%
1/26 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Eczema
|
7.1%
2/28 • Number of events 2
|
3.8%
1/26 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
7/28 • Number of events 9
|
30.8%
8/26 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/28
|
11.5%
3/26 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.1%
2/28 • Number of events 2
|
7.7%
2/26 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
7.1%
2/28 • Number of events 2
|
11.5%
3/26 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place