Trial Outcomes & Findings for Sublingual Cockroach Safety in Adults With Cockroach Allergy & Perennial Allergic Rhinitis With or Without Asthma (NCT NCT00434421)
NCT ID: NCT00434421
Last Updated: 2015-06-11
Results Overview
Proportion of participants who discontinued study for any reason following initiation of treatment (any participant who receives the initial placebo dose will be considered initiated onto treatment)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
Initial placebo dose to end of 2-week treatment course (maximum study dose)
Results posted on
2015-06-11
Participant Flow
The result tables represent the safety population: all subjects that initiated the 1-day, 8-dose escalation, otherwise referred to as the Preliminary Dosing Visit. One subject in the 8-17 age group withdrew from the study after this timepoint and was replaced with another participant.
Participant milestones
| Measure |
German Cockroach Allergen Dosing Group
Initially each subject underwent a 1-day, 8-dose escalation (e.g., one dose of placebo, 0.14 milliliters \[mL\], followed by 7 escalating doses of Glycerinated German Cockroach Allergenic Extract until the Maximum Study Dose \[0.42 mL, 1:10 wt/vol\] or Maximum Tolerated Dose was achieved). This maximum dose became the daily dose - maintenance dose- of Glycerinated German Cockroach Allergenic Extract for the following 14 days.The maintenance dose of 0.42 mL was calculated to contain 3685 bioequivalent allergy units (BAU), with approximately 4.2 mg of German cockroach allergen Bla g 2 and 50 mg of Bla g 1 per dose. Route of administration: sublingual-oral route.
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
German Cockroach Allergen Dosing Group
Initially each subject underwent a 1-day, 8-dose escalation (e.g., one dose of placebo, 0.14 milliliters \[mL\], followed by 7 escalating doses of Glycerinated German Cockroach Allergenic Extract until the Maximum Study Dose \[0.42 mL, 1:10 wt/vol\] or Maximum Tolerated Dose was achieved). This maximum dose became the daily dose - maintenance dose- of Glycerinated German Cockroach Allergenic Extract for the following 14 days.The maintenance dose of 0.42 mL was calculated to contain 3685 bioequivalent allergy units (BAU), with approximately 4.2 mg of German cockroach allergen Bla g 2 and 50 mg of Bla g 1 per dose. Route of administration: sublingual-oral route.
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|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Non-compliance with study treatment
|
1
|
Baseline Characteristics
Sublingual Cockroach Safety in Adults With Cockroach Allergy & Perennial Allergic Rhinitis With or Without Asthma
Baseline characteristics by cohort
| Measure |
German Cockroach Allergen Dosing Group
n=28 Participants
Initially each subject underwent a 1-day, 8-dose escalation (e.g., one dose of placebo, 0.14 milliliters \[mL\], followed by 7 escalating doses of Glycerinated German Cockroach Allergenic Extract until the Maximum Study Dose \[0.42 mL, 1:10 wt/vol\] or Maximum Tolerated Dose was achieved). This maximum dose became the daily dose - maintenance dose- of Glycerinated German Cockroach Allergenic Extract for the following 14 days.The maintenance dose of 0.42 mL was calculated to contain 3685 bioequivalent allergy units (BAU), with approximately 4.2 mg of German cockroach allergen Bla g 2 and 50 mg of Bla g 1 per dose. Route of administration: sublingual-oral route.
|
|---|---|
|
Age, Categorical
<=18 years
|
19 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age, Customized
18-55 years
|
9 participants
n=93 Participants
|
|
Age, Customized
8-17 years
|
10 participants
n=93 Participants
|
|
Age, Customized
5-7 years
|
9 participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=93 Participants
|
|
German Cockroach Skin Test Sensitivity
High
|
18 participants
n=93 Participants
|
|
German Cockroach Skin Test Sensitivity
Low
|
10 participants
n=93 Participants
|
|
Asthma status (Mild-to-moderate persistent asthma)
Yes
|
10 participants
n=93 Participants
|
|
Asthma status (Mild-to-moderate persistent asthma)
No
|
18 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Initial placebo dose to end of 2-week treatment course (maximum study dose)Population: Safety Population: All study participants who were initiated onto the initial placebo study
Proportion of participants who discontinued study for any reason following initiation of treatment (any participant who receives the initial placebo dose will be considered initiated onto treatment)
Outcome measures
| Measure |
German Cockroach Allergen Dosing Group
n=28 Participants
Initially each subject underwent a 1-day, 8-dose escalation (e.g., one dose of placebo, 0.14 milliliters \[mL\], followed by 7 escalating doses of Glycerinated German Cockroach Allergenic Extract until the Maximum Study Dose \[0.42 mL, 1:10 wt/vol\] or Maximum Tolerated Dose was achieved). This maximum dose became the daily dose - maintenance dose- of Glycerinated German Cockroach Allergenic Extract for the following 14 days.The maintenance dose of 0.42 mL was calculated to contain 3685 bioequivalent allergy units (BAU), with approximately 4.2 mg of German cockroach allergen Bla g 2 and 50 mg of Bla g 1 per dose. Route of administration: sublingual-oral route.
|
|---|---|
|
Proportion of Participants Who Discontinue Study
|
7.1 Percentage of Participants
|
Adverse Events
German Cockroach Allergen Dosing Group
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
German Cockroach Allergen Dosing Group
n=28 participants at risk
Initially each subject underwent a 1-day, 8-dose escalation (e.g., one dose of placebo, 0.14 milliliters \[mL\], followed by 7 escalating doses of Glycerinated German Cockroach Allergenic Extract until the Maximum Study Dose \[0.42 mL, 1:10 wt/vol\] or Maximum Tolerated Dose was achieved). This maximum dose became the daily dose - maintenance dose- of Glycerinated German Cockroach Allergenic Extract for the following 14 days.The maintenance dose of 0.42 mL was calculated to contain 3685 bioequivalent allergy units (BAU), with approximately 4.2 mg of German cockroach allergen Bla g 2 and 50 mg of Bla g 1 per dose. Route of administration: sublingual-oral route.
|
|---|---|
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Ear and labyrinth disorders
EAR PRURITUS
|
10.7%
3/28 • Number of events 3 • Initial placebo dose to end of 2-week treatment course
|
|
Eye disorders
EYE PRURITUS
|
7.1%
2/28 • Number of events 2 • Initial placebo dose to end of 2-week treatment course
|
|
Gastrointestinal disorders
CRAMPS
|
3.6%
1/28 • Number of events 1 • Initial placebo dose to end of 2-week treatment course
|
|
Gastrointestinal disorders
DIARRHEA
|
3.6%
1/28 • Number of events 1 • Initial placebo dose to end of 2-week treatment course
|
|
Gastrointestinal disorders
NAUSEA
|
3.6%
1/28 • Number of events 1 • Initial placebo dose to end of 2-week treatment course
|
|
Gastrointestinal disorders
SALIVARY HYPERSECRETION
|
3.6%
1/28 • Number of events 1 • Initial placebo dose to end of 2-week treatment course
|
|
Gastrointestinal disorders
VOMITING
|
3.6%
1/28 • Number of events 1 • Initial placebo dose to end of 2-week treatment course
|
|
Respiratory, thoracic and mediastinal disorders
CHEST DISCOMFORT
|
10.7%
3/28 • Number of events 3 • Initial placebo dose to end of 2-week treatment course
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
7.1%
2/28 • Number of events 2 • Initial placebo dose to end of 2-week treatment course
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
3.6%
1/28 • Number of events 1 • Initial placebo dose to end of 2-week treatment course
|
|
Respiratory, thoracic and mediastinal disorders
NASAL DISCOMFORT
|
3.6%
1/28 • Number of events 1 • Initial placebo dose to end of 2-week treatment course
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
7.1%
2/28 • Number of events 2 • Initial placebo dose to end of 2-week treatment course
|
|
Respiratory, thoracic and mediastinal disorders
SHORTNESS OF BREATH
|
3.6%
1/28 • Number of events 1 • Initial placebo dose to end of 2-week treatment course
|
|
Respiratory, thoracic and mediastinal disorders
SNEEZING
|
3.6%
1/28 • Number of events 1 • Initial placebo dose to end of 2-week treatment course
|
|
Respiratory, thoracic and mediastinal disorders
THROAT IRRITATION
|
21.4%
6/28 • Number of events 8 • Initial placebo dose to end of 2-week treatment course
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
3.6%
1/28 • Number of events 1 • Initial placebo dose to end of 2-week treatment course
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
3.6%
1/28 • Number of events 1 • Initial placebo dose to end of 2-week treatment course
|
|
Skin and subcutaneous tissue disorders
ORAL PRURITUS
|
17.9%
5/28 • Number of events 5 • Initial placebo dose to end of 2-week treatment course
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
10.7%
3/28 • Number of events 4 • Initial placebo dose to end of 2-week treatment course
|
|
Skin and subcutaneous tissue disorders
RASH
|
14.3%
4/28 • Number of events 4 • Initial placebo dose to end of 2-week treatment course
|
|
Skin and subcutaneous tissue disorders
RASH PRURITIC
|
3.6%
1/28 • Number of events 1 • Initial placebo dose to end of 2-week treatment course
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
3.6%
1/28 • Number of events 1 • Initial placebo dose to end of 2-week treatment course
|
Additional Information
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