Trial Outcomes & Findings for Development of Cockroach Immunotherapy by the Inner-City Asthma Consortium (NCT NCT01221285)
NCT ID: NCT01221285
Last Updated: 2014-06-11
Results Overview
Number of non-serious adverse events reported as possibly related, probably related, or definitely related to study participation.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
11 participants
Primary outcome timeframe
Baseline through 6-months of treatment
Results posted on
2014-06-11
Participant Flow
Participant milestones
| Measure |
Glycerinated German Cockroach Allergenic Extract
Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
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|---|---|
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Overall Study
STARTED
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11
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Glycerinated German Cockroach Allergenic Extract
Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
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|---|---|
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Overall Study
Withdrawal by Subject
|
1
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Baseline Characteristics
Development of Cockroach Immunotherapy by the Inner-City Asthma Consortium
Baseline characteristics by cohort
| Measure |
Glycerinated German Cockroach Allergenic Extract
n=10 Participants
Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 mL of extract at a concentration of 1:20 wt/vol.
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|---|---|
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Age, Continuous
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37.5 years
n=5 Participants
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|
Sex: Female, Male
Female
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8 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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10 participants
n=5 Participants
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Participants with Asthma
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7 participants
n=5 Participants
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Participants with Perennial Allergic Rhinitis
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6 participants
n=5 Participants
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Glycerinated German Cockroach Prick Skin Test Wheal Size
|
6.8 mm
n=5 Participants
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|
German Cockroach-Specific Serum Immunoglobulin E (IgE) Levels
|
3.8 kU/L
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline through 6-months of treatmentPopulation: Intent-to-treat
Number of non-serious adverse events reported as possibly related, probably related, or definitely related to study participation.
Outcome measures
| Measure |
Glycerinated German Cockroach Allergenic Extract
n=10 Participants
Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
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|---|---|
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Number of Reported Treatment-related Adverse Events (AEs)
Severe, Definitely
|
0 Events
|
|
Number of Reported Treatment-related Adverse Events (AEs)
Severe, Probably
|
0 Events
|
|
Number of Reported Treatment-related Adverse Events (AEs)
Severe, Possibly
|
0 Events
|
|
Number of Reported Treatment-related Adverse Events (AEs)
Moderate, Definitely
|
0 Events
|
|
Number of Reported Treatment-related Adverse Events (AEs)
Moderate , Probably
|
3 Events
|
|
Number of Reported Treatment-related Adverse Events (AEs)
Moderate , Possibly
|
1 Events
|
|
Number of Reported Treatment-related Adverse Events (AEs)
Mild , Definitely
|
0 Events
|
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Number of Reported Treatment-related Adverse Events (AEs)
Mild Probably
|
47 Events
|
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Number of Reported Treatment-related Adverse Events (AEs)
Mild Possibly
|
99 Events
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PRIMARY outcome
Timeframe: Baseline through 6-months of treatmentPopulation: Intent-to-treat
Number of SAEs reported as possibly related, probably related, or definitely related to study participation.
Outcome measures
| Measure |
Glycerinated German Cockroach Allergenic Extract
n=10 Participants
Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
|
|---|---|
|
Number of Reported Treatment-related Serious Adverse Events (SAEs)
Definitely related
|
0 Events
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|
Number of Reported Treatment-related Serious Adverse Events (SAEs)
Probably related
|
0 Events
|
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Number of Reported Treatment-related Serious Adverse Events (SAEs)
Possibly related
|
0 Events
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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 E (IgE) vs. post-baseline German cockroach-specific serum IgE. Numerator is geometric mean post-baseline IgE; denominator is baseline 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=10 Participants
Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
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|---|---|
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Change in German Cockroach-Specific Serum IgE Over Time
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1.8 Ratio
95% Confidence Interval 0.1 • Interval 1.1 to 2.8
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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 G (IgG) vs. post-baseline German cockroach-specific serum IgG. Numerator is geometric mean post-baseline IgG; denominator is baseline IgG.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=10 Participants
Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
|
|---|---|
|
Change in German Cockroach-Specific Serum IgG Over Time
|
2.5 Ratio
95% Confidence Interval 0.1 • Interval 1.8 to 3.4
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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. Numerator is geometric mean post-baseline IgG4; denominator is baseline IgG4. 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=10 Participants
Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
|
|---|---|
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Change in German Cockroach-Specific Serum IgG4 Over Time
|
12.9 Ratio
95% Confidence Interval 0.7 • Interval 7.5 to 22.5
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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 cockroach subcutaneous immunotherapy (SCIT)-treated participants were analyzed to determine if treatment inhibits the in-vitro cockroach antigen binding to B-cells after 6-months of treatment with cockroach SCIT, using the per protocol allergenic extract doses. 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=10 Participants
Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
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|---|---|
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Change in IgE Fragment Antibody Binding (FAB) Activity (10 Micrograms/mL Cockroach Allergen Extract)
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-42.8 Percent antibody binding
Standard Error 8.3
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Adverse Events
Experimental: German Cockroach Allergenic Extract
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental: German Cockroach Allergenic Extract
n=10 participants at risk
Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
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|---|---|
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Infections and infestations
Bronchitis
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10.0%
1/10 • Number of events 1
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Infections and infestations
Localised infection
|
10.0%
1/10 • Number of events 1
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Other adverse events
| Measure |
Experimental: German Cockroach Allergenic Extract
n=10 participants at risk
Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
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|---|---|
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Ear and labyrinth disorders
Ear pruritus
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20.0%
2/10 • Number of events 4
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Eye disorders
Eye pruritus
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10.0%
1/10 • Number of events 2
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Eye disorders
Eye swelling
|
10.0%
1/10 • Number of events 2
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Eye disorders
Lacrimation increased
|
10.0%
1/10 • Number of events 1
|
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Gastrointestinal disorders
Abdominal discomfort
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Lip pain
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Lip swelling
|
10.0%
1/10 • Number of events 1
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Gastrointestinal disorders
Nausea
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10.0%
1/10 • Number of events 1
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Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Number of events 1
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General disorders
Influenza like illness
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10.0%
1/10 • Number of events 1
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General disorders
Injection site anaesthesia
|
10.0%
1/10 • Number of events 1
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|
General disorders
Injection site eczema
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10.0%
1/10 • Number of events 1
|
|
General disorders
Injection site erosion
|
20.0%
2/10 • Number of events 2
|
|
General disorders
Injection site erythema
|
60.0%
6/10 • Number of events 15
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General disorders
Injection site haemorrhage
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10.0%
1/10 • Number of events 1
|
|
General disorders
Injection site pain
|
20.0%
2/10 • Number of events 4
|
|
General disorders
Injection site pruritus
|
90.0%
9/10 • Number of events 53
|
|
General disorders
Injection site swelling
|
90.0%
9/10 • Number of events 43
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|
General disorders
Injection site urticaria
|
10.0%
1/10 • Number of events 1
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Hepatobiliary disorders
Cholelithiasis
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Bronchitis
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10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
10.0%
1/10 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Blood urine present
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
2/10 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
20.0%
2/10 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
20.0%
2/10 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
30.0%
3/10 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
30.0%
3/10 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
10.0%
1/10 • Number of events 7
|
|
Surgical and medical procedures
Wisdom teeth removal
|
10.0%
1/10 • Number of events 1
|
Additional Information
Associate Director, Clinical Research Operations Program
DAIT/NIAID
Phone: 301-594-7669
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place