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| ID | Type | Description | Link |
|---|---|---|---|
| CoNAC | Other Identifier | ICAC |
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| Name | Class |
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| Inner-City Asthma Consortium | NETWORK |
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This research is being done to look at the body's response to cockroach extract, an allergen, when sprayed into the nose. The spraying of the cockroach extract into the participant's nose is called Nasal Allergen Challenge (NAC). The purpose of this study is to evaluate the safety and tolerability of a intranasal cockroach extract given to participants with asthma.
This is a multi-center, open label pilot study to assess the safety and determine the feasibility of cockroach nasal allergen challenge in children with asthma. This pilot study will occur in two phases:
Study mandated procedures include: blood draws (venipuncture); pulmonary function testing (PFTs); nasal allergen challenge (NAC); allergen skin testing; and peak expiratory flow.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glycerinated CR Allergenic Extract | Experimental | Complete Arm Title: Glycerinated German Cockroach Allergenic Extract. Cockroach sensitive subjects are exposed to cockroach nasal allergen (NAC) intranasally at at increasing doses per protocol. The NAC aim is pursuit of optimal dose range as determined by tolerability and eliciting a threshold of nasal symptoms. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glycerinated German Cockroach Allergenic Extract | Biological | Participants will receive escalating doses intranasally. Briefly: per protocol- Phase 1a NAC: N=10 cockroach sensitive adults with asthma will undergo nasal allergen challenge with dose escalation (up to 8 doses per protocol). Phase 1b: Phase 1a subjects will have repeat NAC with dose escalation (up to 8 doses). Phase 2: N=25 cockroach sensitive children with asthma (ages 8 - 14 years) will undergo NAC with doses determined by Phase 1a data (e.g., symptoms and safety data). |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Proportion of Participants Meeting Either a Total Nasal Symptom Score (TNSS) Threshold or Sneezing Score Threshold During the Cockroach Allergen (CA) Nasal Allergen Challenge (NAC) | Result is the proportion of participants (Pss) responding at each of 9 CA doses during the NAC.To illustrate the variability of the outcome at each dose,the protocol specifies computation of 95% CIs for the proportion responding at each dose.A proportion is to record for each Ps a 0 for non-responder and 1 for responder &compute the mean of the 0 &1 values.Summary statistic for this method: a mean. After each dose,TNSS &TNSS Sneezing scores were recorded.TNSS (0-12) is a self-rated score computed as the sum of 4 subscale scores (0-3) measuring sneezing, runny nose, stuffy nose, & itchy nose symptoms (sxs).Pss provide a score on each subscale of 0, 1, 2, or 3(none, mild, moderate, or severe sxs, respectively).Pss cont'd receiving doses until either a TNSS (≥8 in adults,≥6 in children) or sneezing score threshold [TLV] of 3 was met.Assumption: Pss met TLV criteria for doses not recv'd beyond dose at which TLV criteria were initially met. | NAC Baseline through last dose of German cockroach allergen administered during the NAC |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Sneezes at Each of Nine Doses of German Cockroach Allergen | Nine increasing doses of German cockroach allergen (0, 0.00381, 0.01204, 0.0380, 0.120, 0.379, 1.20, 3.78, and 11.9 mcg/mL) were administered during the Nasal Allergen Challenge (NAC). After administration of each dose, the number of times the participant sneezed was recorded. Participants continued receiving doses of German cockroach allergen until threshold criteria described in the primary endpoint were met. Number of sneezes was carried forward for doses not received beyond the dose at which the threshold criteria were initially met. Number of sneezes is summarized at each dose. |
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Accrual Objective: N=10 adults, 25 children)
STUDY INCLUSION CRITERIA:
Subjects fulfilling all of the following criteria are eligible for enrollment as study participants for Phase 1a and Phase 2:
Subject and/or parent guardian must be able to understand and provide informed consent.
Male or female adults, 18 through 55 years of age at recruitment (Phase 1) or male or female children, 8-14 years of age at recruitment (Phase 2).
Have a history of asthma for a minimum of 1 year before study entry:
A diagnosis of asthma for this study is defined as a reported clinical diagnosis of asthma made by a physician over a year ago.
The subject must have persistent asthma defined by the current need for at least 100 microgram (mcg) fluticasone per day or the equivalent of another inhaled corticosteroid.
The subject's asthma must be well controlled as defined by:
Are sensitive to German Cockroach as documented by a positive (≥ 3 mm greater than negative control) skin prick test result and a positive German Cockroach specific immunoglobulin E (IgE) (≥0.35 kUA/L).
Have no known contraindications to the allergenic extracts or diluents.
Subjects who meet the following criteria are eligible for enrollment as study participants in Phase 1b after completion of Phase 1a:
Their asthma must be well controlled as defined by:
The subject tolerated the Nasal Allergen Challenge (NAC) during Phase 1a with no adverse events grade 2 or higher as determined by "Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (published September 2007) for local reactions to study procedures."
Subjects not eligible for enrollment as study participants in Phase 1b after completion of Phase 1a if any of the following criteria are met:
Are pregnant or lactating.
Have an asthma severity classification of severe persistent, using the NAEPP classification, as evidenced by at least one of the following:
Have received allergen immunotherapy (SLIT or SCIT) in the last 12 months prior to their participation in Phase 1b.
Have previously been treated with anti-IgE therapy in the 12 months prior to their participation in Phase 1b.
Are currently receiving oral or nasal antihistamines, nasal corticosteroids, nasal decongestants, nasal anticholinergics or cromolyn, which cannot be suspended for the required washout periods prior to the nasal allergen challenge in Phase 1b.
Have received an investigational drug in the 30 days prior to their participation in Phase 1b.
Have past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the subject's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
Meet any of the Participant Stopping Rules and Withdrawal Criteria during Phase 1a
The subject's initial TNSS at the Repeat Challenge Visit must be within 1 point of the initial TNSS at the Challenge Visit in Phase 1a. If the participant's initial TNSS is outside the 1 point range, then the participant may be reevaluated for the Repeat Challenge Visit up to 3 additional times.
STUDY EXCLUSION CRITERIA:
Subjects fulfilling any of the following criteria are not eligible for enrollment in any portion of the study and may not be reassessed. Participants are ineligible if they:
EXCLUSION CRITERIA SPECIFIC TO STUDY PHASE 1A AND -2:
Subjects who meet any of these criteria are not eligible for enrollment as study participants in Phase1a and Phase 2:
Are pregnant or lactating. Post-menarcheal females must be abstinent or use a medically acceptable birth control method throughout the study (e.g. oral, subcutaneous, mechanical, or surgical contraception).
Cannot perform spirometry at Screening.
Have an asthma severity classification at Recruitment of severe persistent, using the The National Asthma Education and Prevention Program (NAEPP) classification, as evidenced by at least one of the following:
Have nasal polyps or other major structural abnormalities in their nasal cavities as assessed by anterior rhinoscopy.
Have active rhinitis symptoms prior to the nasal allergen challenge, defined as a Baseline Total Nasal Symptom Score(TNSS) >3,with no individual symptom score >1.
Do not have access to a phone (needed for scheduling appointments).
Have received allergen immunotherapy (Sublingual [SLIT] or Subcutaneous [SCIT]) in the last 12 months prior to recruitment or who plan to initiate or resume allergen immunotherapy during the study.
Have previously been treated with anti-IgE therapy in the 12 months prior to recruitment.
Are currently receiving oral or nasal antihistamines, nasal corticosteroids, nasal decongestants,nasal anticholinergics or cromolyn, which cannot be suspended for the required washout periods prior to skin prick testing and the nasal allergen challenge.
Have received an investigational drug in the 30 days prior to recruitment or who plan to use an investigational drug during the study.
Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
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| Name | Affiliation | Role |
|---|---|---|
| Robert Wood, MD | Johns Hopkins University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States | ||
| Children's National Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33606312 | Derived | Rudman Spergel AK, Sever ML, Johnson J, Gill MA, Schulten V, Frazier A, Kercsmar CM, Lovinsky-Desir S, Searing DA, Sette A, Shao B, Teach SJ, Gern JE, Busse WW, Togias A, Wood RA, Liu AH; National Institute of Allergy and Infectious Diseases Inner City Asthma Consortium. Development of nasal allergen challenge with cockroach in children with asthma. Pediatr Allergy Immunol. 2021 Jul;32(5):971-979. doi: 10.1111/pai.13480. Epub 2021 Mar 20. |
| Label | URL |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | View source |
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The plan is to share data upon completion of the study in ImmPort, a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
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The aim is to share data available to the public within 24 months upon completion of the study.
ImmPort public data access.
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Of the 182 participants recruited, 80 participants consented to be screened for study eligibility. Among the five participating clinical research sites, all located in the United States, 35 participants enrolled to participate in the study. Enrollment was active from February 2016 to March 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cockroach Sensitive Adults With Asthma | In Phase 1a, adult participants ages 18-55 underwent a nasal allergen challenge (NAC) with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥8 or a sneezing score=3. Participants who completed the NAC in Phase 1a were invited to assess additional screening criteria and return for a second nasal allergen challenge in Phase 1b to evaluate the reproducibility of the NAC in determining nasal symptoms in response to German cockroach allergen. |
| FG001 | Cockroach Sensitive Children With Asthma | In Phase 2, pediatric participants ages 8-14 underwent a nasal allergen challenge with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥6 or a sneezing score=3. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Study Enrollment |
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| Phase 1a[Refer to Arm/Group Description] |
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| Phase 1b[Refer to Arm/Group Description] |
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| Phase 2 [Refer to Arm/Group Description] |
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Phase 1a and Phase 2 participants who started a Nasal Allergen Challenge
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| ID | Title | Description |
|---|---|---|
| BG000 | Cockroach Sensitive Adults With Asthma | In Phase 1a, adult participants ages 18-55 underwent a nasal allergen challenge (NAC) with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥8 or a sneezing score=3. Participants who completed the NAC in Phase 1a were invited to assess additional screening criteria and return for a second nasal allergen challenge in Phase 1b to evaluate the reproducibility of the NAC in determining nasal symptoms in response to German cockroach allergen. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cumulative Proportion of Participants Meeting Either a Total Nasal Symptom Score (TNSS) Threshold or Sneezing Score Threshold During the Cockroach Allergen (CA) Nasal Allergen Challenge (NAC) | Result is the proportion of participants (Pss) responding at each of 9 CA doses during the NAC.To illustrate the variability of the outcome at each dose,the protocol specifies computation of 95% CIs for the proportion responding at each dose.A proportion is to record for each Ps a 0 for non-responder and 1 for responder &compute the mean of the 0 &1 values.Summary statistic for this method: a mean. After each dose,TNSS &TNSS Sneezing scores were recorded.TNSS (0-12) is a self-rated score computed as the sum of 4 subscale scores (0-3) measuring sneezing, runny nose, stuffy nose, & itchy nose symptoms (sxs).Pss provide a score on each subscale of 0, 1, 2, or 3(none, mild, moderate, or severe sxs, respectively).Pss cont'd receiving doses until either a TNSS (≥8 in adults,≥6 in children) or sneezing score threshold [TLV] of 3 was met.Assumption: Pss met TLV criteria for doses not recv'd beyond dose at which TLV criteria were initially met. | Phase 1a and Phase 2 Participants who started a NAC | Posted | Mean | 95% Confidence Interval | Cumulative proportion of participants | NAC Baseline through last dose of German cockroach allergen administered during the NAC |
Time of consent until participant completed study participation or until 10 days have participant prematurely withdraws (without withdrawing consent) or was withdrawn from the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1a Cockroach Sensitive Adults With Asthma | Adverse events captured during Screening and Phase 1a are included. In Phase 1a, adult participants ages 18-55 underwent a nasal allergen challenge (NAC) with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥8 or a sneezing score=3. Participants who completed the NAC in Phase 1a were invited to return for a second nasal allergen challenge in Phase 1b to assess the reproducibility of the NAC in determining nasal symptoms in response to German cockroach allergen. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Herpes simplex | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis allergic | Eye disorders | MedDRA 18.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research Operations Program | DAIT/NIAID | 301-594-7669 | DAITClinicalTrialsGov@niaid.nih.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 9, 2016 | Apr 20, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 6, 2017 | Apr 20, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| NAC Baseline through last dose of German cockroach allergen administered during the NAC |
| Highest Total Nasal Symptom Score (TNSS) | TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring sneezing, runny nose, stuffy nose, and itchy nose symptoms. Participants provide a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. The highest TNSS observed after administration of any of the German cockroach allergen doses received during the Nasal Allergen Challenge (NAC) is summarized. | NAC Baseline through last dose of German cockroach allergen administered during the NAC |
| Change in Total Nasal Symptom Score (TNSS) | TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring sneezing, runny nose, stuffy nose, and itchy nose symptoms. Participants indicate a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. Change is computed by subtracting the TNSS score obtained after the nasal rinse administered prior to the Nasal Allergen Challenge from the TNSS score obtained at the last tolerated dose of German cockroach allergen received during the Nasal Allergen Challenge (NAC). A positive change score indicates that nasal symptoms increased over the course of the NAC. | NAC Baseline through last dose of German cockroach allergen administered during the NAC |
| Change in Peak Nasal Inspiratory Flow (PNIF) L/Min | PNIF is defined as the speed of inspiration of air in Liters per minute when breathing into the lungs. Change is computed by subtracting the PNIF score obtained after the nasal rinse administered prior to the Nasal Allergen Challenge (NAC) from the PNIF score obtained at the last tolerated dose of German cockroach allergen received during the NAC. A negative change score indicates that speed of inspiration decreased over the course of the NAC. | NAC Baseline through last dose of German cockroach allergen administered during the NAC |
| Change in Peak Expiratory Flow (PEF) L/Min | PEF is defined as the speed of expiration of air in Liters per minute when breathing out of the lungs. Change is computed by subtracting the PEF score obtained after the nasal rinse administered prior to the Nasal Allergen Challenge (NAC) from the PEF score obtained at the last tolerated dose of German cockroach allergen received during the NAC. A positive change score indicates that speed of expiration increased over the course of the Challenge, while a negative change score indicates speed of expiration decreased over the course of the NAC. | NAC Baseline through last dose of German cockroach allergen administered during the NAC |
| Change in Visual Analogue Score | Participants self-reported their score, reflecting the severity of their nasal symptoms-sneezing, runny nose, stuffy nose, itchy nose- on a Visual Analogue Scale (0 to 10 centimeters). The left-hand side of the scale (0) represents "No Symptoms," and the right hand side of the scale (10) represents "As Bad as I Can Imagine." Change is computed by subtracting the VAS score obtained after the nasal rinse administered prior to the Nasal Allergen Challenge (NAC) from the VAS score obtained at the last tolerated dose of German cockroach allergen received during the NAC. A positive change score indicates that nasal symptoms increased over the course of the NAC. | NAC Baseline through last dose of German cockroach allergen administered during the NAC |
| Change in Log Base 10 Tryptase in Nasal Secretions | Tryptase is a protein in the human body. Levels are hypothesized to be related to the extent of allergic response. Change is computed by subtracting the tryptase level prior to the Nasal Allergen Challenge (NAC) from the tryptase level after the last dose received during the NAC. A log base 10 transformation is applied to both baseline and post-baseline measures. A positive change score indicates that tryptase levels increased over the course of the NAC. | NAC Baseline through last dose of German cockroach allergen administered during the NAC |
| Change in Log Base 10 Albumin in Nasal Secretions | Albumin is a protein in the human body. Levels are hypothesized to be related to the extent of allergic response. Change is computed by subtracting the albumin level prior to the Nasal Allergen Challenge (NAC) from the albumin level after the last dose received during the NAC. A log base 10 transformation is applied to both baseline and post-baseline measures. A positive change score indicates that albumin levels increased over the course of the NAC. | NAC Baseline through last dose of German cockroach allergen administered during the NAC |
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Division of Allergy, Immunology, and Transplantation (DAIT) | View source |
| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | Cockroach Sensitive Children With Asthma | In Phase 2, pediatric participants ages 8-14 underwent a nasal allergen challenge with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥6 or a sneezing score=3. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| German cockroach allergen Bla g 1, Bla g 2, or Bla g 5 ng/g levels in home dust above LLD (yes/no) | Blatella germanica 1 (Bla g 1), Blatella germanica 2 (Bla g 2), and Blatella germanica 5 (Bla g 5) are cockroach proteins that cause allergy to cockroach in humans. Levels above the lower limit of detection (LLD) indicate the presence of cockroaches in the home. LLD for Bla g 1, Bla g 2, and Bla g 5 were 120, 196, and 140 ng/g, respectively. | Count of Participants | Participants |
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| German cockroach allergen skin test wheal size (mm) | Extent of allergy to German cockroach can be assessed using a skin prick test. In this test, a small amount of allergen is introduced to the skin via a needle, and then the diameter of the resulting swelling, called a wheal, is measured. Larger wheal sizes indicate greater allergy to German cockroach. | Geometric Mean | Standard Deviation | mm |
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| German cockroach allergen IgE (kU/L) | Extent of allergy to German cockroach can be assessed using levels of German cockroach specific Immunoglobulin E (IgE). IgE are antibodies produced by the immune system, so that higher levels of IgE present indicate greater allergy to German cockroach. IgE levels are measured in the serum (blood test). | Geometric Mean | Standard Deviation | kU/L |
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| Total Nasal Symptom Score (TNSS) | Total Nasal Symptom Score (TNSS) (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring sneezing, runny nose, stuffy nose, and itchy nose symptoms. Participants indicate a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. Baseline TNSS scores were obtained after the nasal rinse administered prior to the Nasal Allergen Challenge. Higher scores indicate more severe nasal symptoms. | Mean | Standard Deviation | Scores on a Scale |
|
| Peak Nasal Inspiratory Flow (PNIF) L/min | PNIF is defined as the speed of inspiration of air in Liters per minute when breathing into the lungs. Baseline PNIF scores were obtained after the nasal rinse administered prior to the Nasal Allergen Challenge. Lower scores indicate less ability to breathe air into the lungs due to more severe nasal symptoms. | Mean | Standard Deviation | L/min |
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| Peak Expiratory Flow (PEF) L/min | PEF is defined as the speed of expiration of air in Liters per minute when breathing out of the lungs. Baseline PEF scores were obtained after the nasal rinse administered prior to the Nasal Allergen Challenge. Lower scores indicate less ability to expel air out of the lungs due to more severe nasal symptoms. | Mean | Standard Deviation | L/min |
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| Visual Analog Score (VAS) | Participants self-reported their score, reflecting the severity of their nasal symptoms-sneezing, runny nose, stuffy nose, itchy nose- on a Visual Analogue Scale (0 to 10 centimeters). The left-hand side of the scale (0) represents "No Symptoms," and the right hand side of the scale (10) represents "As Bad as I Can Imagine." Baseline VAS scores were obtained after the nasal rinse administered prior to the Nasal Allergen Challenge. | Mean | Standard Deviation | Centimeters |
|
| Log base 10 Tryptase in Nasal Secretions | Tryptase is a protein in the human body whose levels are hypothesized to be related to extent of allergic response. Baseline tryptase scores were obtained after the nasal rinse administered prior to the Nasal Allergen Challenge. Higher scores indicate more allergic response. | Mean | Standard Deviation | mcg/L |
|
| Log base 10 Albumin in Nasal Secretions | Albumin is a protein in the human body whose levels are hypothesized to be related to extent of allergic response. Baseline albumin scores were obtained after the nasal rinse administered prior to the Nasal Allergen Challenge. Higher scores indicate more allergic response. | Mean | Standard Deviation | mcg/L |
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| Secondary | Number of Sneezes at Each of Nine Doses of German Cockroach Allergen | Nine increasing doses of German cockroach allergen (0, 0.00381, 0.01204, 0.0380, 0.120, 0.379, 1.20, 3.78, and 11.9 mcg/mL) were administered during the Nasal Allergen Challenge (NAC). After administration of each dose, the number of times the participant sneezed was recorded. Participants continued receiving doses of German cockroach allergen until threshold criteria described in the primary endpoint were met. Number of sneezes was carried forward for doses not received beyond the dose at which the threshold criteria were initially met. Number of sneezes is summarized at each dose. | Phase 1a and Phase 2 Participants who started a NAC | Posted | Mean | Standard Deviation | Count of sneezes | NAC Baseline through last dose of German cockroach allergen administered during the NAC |
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| Secondary | Highest Total Nasal Symptom Score (TNSS) | TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring sneezing, runny nose, stuffy nose, and itchy nose symptoms. Participants provide a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. The highest TNSS observed after administration of any of the German cockroach allergen doses received during the Nasal Allergen Challenge (NAC) is summarized. | Phase 1a and Phase 2 Participants who started a NAC | Posted | Mean | Standard Deviation | Scores on a Scale | NAC Baseline through last dose of German cockroach allergen administered during the NAC |
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| Secondary | Change in Total Nasal Symptom Score (TNSS) | TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring sneezing, runny nose, stuffy nose, and itchy nose symptoms. Participants indicate a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. Change is computed by subtracting the TNSS score obtained after the nasal rinse administered prior to the Nasal Allergen Challenge from the TNSS score obtained at the last tolerated dose of German cockroach allergen received during the Nasal Allergen Challenge (NAC). A positive change score indicates that nasal symptoms increased over the course of the NAC. | Phase 1a and Phase 2 Participants who started a NAC | Posted | Mean | Standard Deviation | Scores on a Scale | NAC Baseline through last dose of German cockroach allergen administered during the NAC |
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| Secondary | Change in Peak Nasal Inspiratory Flow (PNIF) L/Min | PNIF is defined as the speed of inspiration of air in Liters per minute when breathing into the lungs. Change is computed by subtracting the PNIF score obtained after the nasal rinse administered prior to the Nasal Allergen Challenge (NAC) from the PNIF score obtained at the last tolerated dose of German cockroach allergen received during the NAC. A negative change score indicates that speed of inspiration decreased over the course of the NAC. | Phase 1a and Phase 2 Participants who started a NAC | Posted | Mean | Standard Deviation | L/min | NAC Baseline through last dose of German cockroach allergen administered during the NAC |
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| Secondary | Change in Peak Expiratory Flow (PEF) L/Min | PEF is defined as the speed of expiration of air in Liters per minute when breathing out of the lungs. Change is computed by subtracting the PEF score obtained after the nasal rinse administered prior to the Nasal Allergen Challenge (NAC) from the PEF score obtained at the last tolerated dose of German cockroach allergen received during the NAC. A positive change score indicates that speed of expiration increased over the course of the Challenge, while a negative change score indicates speed of expiration decreased over the course of the NAC. | Phase 1a and Phase 2 Participants who started a NAC | Posted | Mean | Standard Deviation | L/min | NAC Baseline through last dose of German cockroach allergen administered during the NAC |
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| Secondary | Change in Visual Analogue Score | Participants self-reported their score, reflecting the severity of their nasal symptoms-sneezing, runny nose, stuffy nose, itchy nose- on a Visual Analogue Scale (0 to 10 centimeters). The left-hand side of the scale (0) represents "No Symptoms," and the right hand side of the scale (10) represents "As Bad as I Can Imagine." Change is computed by subtracting the VAS score obtained after the nasal rinse administered prior to the Nasal Allergen Challenge (NAC) from the VAS score obtained at the last tolerated dose of German cockroach allergen received during the NAC. A positive change score indicates that nasal symptoms increased over the course of the NAC. | Phase 1a and Phase 2 Participants who started a NAC | Posted | Mean | Standard Deviation | Centimeters | NAC Baseline through last dose of German cockroach allergen administered during the NAC |
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| Secondary | Change in Log Base 10 Tryptase in Nasal Secretions | Tryptase is a protein in the human body. Levels are hypothesized to be related to the extent of allergic response. Change is computed by subtracting the tryptase level prior to the Nasal Allergen Challenge (NAC) from the tryptase level after the last dose received during the NAC. A log base 10 transformation is applied to both baseline and post-baseline measures. A positive change score indicates that tryptase levels increased over the course of the NAC. | Phase 1a and Phase 2 Participants who started a NAC and had an evaluable baseline and post-baseline tryptase measurement. | Posted | Mean | Standard Deviation | mcg/L | NAC Baseline through last dose of German cockroach allergen administered during the NAC |
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| Secondary | Change in Log Base 10 Albumin in Nasal Secretions | Albumin is a protein in the human body. Levels are hypothesized to be related to the extent of allergic response. Change is computed by subtracting the albumin level prior to the Nasal Allergen Challenge (NAC) from the albumin level after the last dose received during the NAC. A log base 10 transformation is applied to both baseline and post-baseline measures. A positive change score indicates that albumin levels increased over the course of the NAC. | Phase 1a and Phase 2 Participants who started a NAC and had an evaluable baseline and post-baseline albumin measurement. | Posted | Mean | Standard Deviation | mcg/L | NAC Baseline through last dose of German cockroach allergen administered during the NAC |
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| 0 |
| 10 |
| 1 |
| 10 |
| 4 |
| 10 |
| EG001 | Phase 1b Cockroach Sensitive Adults With Asthma | Adverse events captured during Phase 1b are included. In Phase 1a, adult participants ages 18-55 underwent a nasal allergen challenge (NAC) with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥8 or a sneezing score=3. Participants who completed the NAC in Phase 1a were invited to assess additional screening criteria and return for a second nasal allergen challenge in Phase 1b to evaluate the reproducibility of the NAC in determining nasal symptoms in response to German cockroach allergen. | 0 | 4 | 0 | 4 | 2 | 4 |
| EG002 | Cockroach Sensitive Children With Asthma | Adverse events captured during Phase 2 are included. In Phase 2, pediatric participants ages 8-14 underwent a nasal allergen challenge with increasing doses of German cockroach allergen. At each allergen dose, the Total Nasal Symptom Score (TNSS; 0-12) was determined. This score is the sum of subscale scores measuring sneezing (0-3), runny nose (0-3), stuffy nose (0-3), and itchy nose (0-3) symptoms. Results were used to identify a range of doses that are safe and elicit nasal symptoms of TNSS ≥6 or a sneezing score=3. | 0 | 25 | 1 | 25 | 7 | 25 |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Vessel puncture site pain | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Xerosis | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Anaphylactic reaction | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Concussion | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
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| Peak expiratory flow rate decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
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Not provided
Not provided
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Dose 3 - 0.01204 mcg/mL |
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| Dose 4 - 0.0380 mcg/mL |
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| Dose 5 - 0.120 mcg/mL |
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| Dose 6 - 0.379 mcg/mL |
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| Dose 7 - 1.20 mcg/mL |
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| Dose 8 - 3.78 mcg/mL |
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| Dose 9 - 11.9 mcg/mL |
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