CompletedNCT02710136Updated Sep 25, 2018Results posted

Cockroach Nasal Allergen Challenge Pilot

A Phase 1 interventional study of Glycerinated German Cockroach Allergenic Extract in Asthma and Cockroach Hypersensitivity, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 4 sites in United States. Open to participants aged 8 Years to 55 Years. Per ClinicalTrials.gov, last updated 2018-09-25.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 35
Allocation: Not applicable
Ages: 8 Years to 55 Years
Sex: All

Study summary

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.

Read the detailed description

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:

Phase 1 will enroll 10 cockroach sensitive adults with asthma who will undergo a nasal allergen challenge with increasing doses of cockroach allergen. Phase 1 will consist of two parts, Phase 1a and Phase 1b. In Phase 1a, participants will undergo a nasal allergen challenge. In Phase 1b, participants will undergo a repeat nasal allergen challenge to assess reproducibility of the NAC with cockroach allergen in a population with asthma. The data from Phase 1a will be used to identify a range of doses that is safe and elicits a threshold of nasal symptoms (TNSS ≥8).
Phase 2 will enroll 25 cockroach sensitive children with asthma ages 8-14 years who will undergo a nasal allergen challenge using the dose range identified in Phase 1a.

Study mandated procedures include: blood draws (venipuncture); pulmonary function testing (PFTs); nasal allergen challenge (NAC); allergen skin testing; and peak expiratory flow.

Conditions studied

Asthma
Cockroach Hypersensitivity

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Keywords

Asthma
Glycerinated German cockroach allergenic extract
Cockroach Nasal Allergen Challenge

In context

Asthma

3,920 studies on the registry are indexed under Asthma; 506 are open to participants now.

This study's enrollment of 35 is below the median of 83 across 2,751 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.

Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 8 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

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:
1. Subject and/or parent guardian must be able to understand and provide informed consent.
2. 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).
3. Have a history of asthma for a minimum of 1 year before study entry:
  1. A diagnosis of asthma for this study is defined as a reported clinical diagnosis of asthma made by a physician over a year ago.
  2. 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.
  3. The subject's asthma must be well controlled as defined by:
    - A Forced Expiratory Volume in 1 Second (FEV1) ≥ 80% predicted.
    - An Asthma Control Test (ACT) score ≥ 20.
4. 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).
5. 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:
1. Their asthma must be well controlled as defined by:
  1. A FEV1 ≥ 80% predicted.
  2. An Asthma Control Test (ACT) score ≥ 20.
2. 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:
1. Are pregnant or lactating.
2. Have an asthma severity classification of severe persistent, using the NAEPP classification, as evidenced by at least one of the following:
  1. Require a dose of greater than 500 mcg of fluticasone per day or the equivalent of another inhaled corticosteroid.
  2. Have received more than 2 courses of oral or parenteral corticosteroids within the last 12 months or one course within the last 3 months.
  3. Have been treated with depot corticosteroids within the last 12 months.
  4. Have been hospitalized for asthma within the 12 months prior to their participation in Phase1b.
  5. Have had an emergency room visit for asthma within the 3 months prior to their participation in Phase 1b.
  6. Have had a life-threatening asthma exacerbation that required intubation, mechanical ventilation, or that resulted in a hypoxic seizure within 2 years prior to their participation in Phase 1b.
3. Have received allergen immunotherapy (SLIT or SCIT) in the last 12 months prior to their participation in Phase 1b.
4. Have previously been treated with anti-IgE therapy in the 12 months prior to their participation in Phase 1b.
5. 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.
6. Have received an investigational drug in the 30 days prior to their participation in Phase 1b.
7. 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.
8. Meet any of the Participant Stopping Rules and Withdrawal Criteria during Phase 1a
  - The participant elected to withdraw consent from all future study activities, including followup.
  - The Investigator no longer believes participation is in the best interest of the participant.
  - Serious Adverse Event (SAE) related to investigational product.
  - Anaphylactic reaction grade 2 or 3.
  - Inability to tolerate the NAC prior to reaching a TNSS ≥8 due to excessive discomfort or symptoms.
  - Epistaxis occurring during the Challenge Visit.
  - The need to start immunotherapy or any chronic immunosuppressive medications in the period between Phase 1a and Phase 1b.
  - Require a dose of greater than 500 mcg of fluticasone per day or the equivalent of another inhaled corticosteroid to maintain asthma control in the period between Phase 1a and Phase 1b.
  - Inability to restrict use of antihistamines, nasal steroids, nasal decongestants, nasal anticholinergics or cromolyn prior to the NAC.
  - Development of any serious medical illness whose natural history, sequela, or treatment would be worsened or impaired by continuation in the protocol.
  - Subject is "lost to follow-up"
9. 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:

Plan to move from the area during the study period.
Have a history of idiopathic anaphylaxis or anaphylaxis grade 2 or higher as defined by the grading scale of Brown et al. for anaphylaxis and systemic reactions to study procedures.
Have unstable angina, significant arrhythmia, uncontrolled hypertension, history of autoimmune disease, or other chronic or immunological diseases that in the opinion of the investigator might interfere with the evaluation of the investigational agent or pose additional risk to the participant.
Are using tricyclic antidepressants or beta-adrenergic blocker drugs (both oral and topical).

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:
1. 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).
2. Cannot perform spirometry at Screening.
3. 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:
  1. Require a dose of greater than 500mcg of fluticasone per day or the equivalent of another inhaled corticosteroid.
  2. Have received more than 2 courses of oral or parenteral corticosteroids within the last 12 months or one course within the last 3 months.
  3. Have been treated with depot corticosteroids within the last 12 months.
  4. Have been hospitalized for asthma within the 12 months prior to recruitment.
  5. Have had an emergency room visit for asthma within the 3 months prior to recruitment.
  6. Have had a life-threatening asthma exacerbation that required intubation, mechanical ventilation, or that resulted in a hypoxic seizure within 2 years prior to recruitment.
4. Have nasal polyps or other major structural abnormalities in their nasal cavities as assessed by anterior rhinoscopy.
5. 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.
6. Do not have access to a phone (needed for scheduling appointments).
7. 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.
8. Have previously been treated with anti-IgE therapy in the 12 months prior to recruitment.
9. 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.
10. Have received an investigational drug in the 30 days prior to recruitment or who plan to use an investigational drug during the study.
11. 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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 35 participants (actual)

Study arms

Experimental
Glycerinated CR Allergenic Extract
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.
Biological: Glycerinated German Cockroach Allergenic Extract

Interventions

BiologicalGlycerinated German Cockroach Allergenic Extract
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).
Also known as: Blattella germanica allergenic extract, Cockroach antigen (CR antigen)

What researchers measure

Primary outcomes

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.
Time frame: NAC Baseline through last dose of German cockroach allergen administered during the NAC

Secondary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: NAC Baseline through last dose of German cockroach allergen administered during the NAC

Results

Posted Aug 28, 2018

Participant flow

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.

Study Enrollment

Participant flow — Study Enrollment
Milestone	Cockroach Sensitive Adults With Asthma	Cockroach Sensitive Children With Asthma
Started	10	25
Completed	10	25
Not completed	0	0

Phase 1a[Refer to Arm/Group Description]

Participant flow — Phase 1a[Refer to Arm/Group Description]
Milestone	Cockroach Sensitive Adults With Asthma	Cockroach Sensitive Children With Asthma
Started	10	0
Completed	9	0
Not completed	1	0
Withdrew: Adverse event	1	0

Phase 1b[Refer to Arm/Group Description]

Participant flow — Phase 1b[Refer to Arm/Group Description]
Milestone	Cockroach Sensitive Adults With Asthma	Cockroach Sensitive Children With Asthma
Started	4	0
Completed	4	0
Not completed	0	0

Phase 2 [Refer to Arm/Group Description]

Participant flow — Phase 2 [Refer to Arm/Group Description]
Milestone	Cockroach Sensitive Adults With Asthma	Cockroach Sensitive Children With Asthma
Started	0	25
Completed	0	25
Not completed	0	0

Outcome measures

PrimaryCumulative 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.

Time frame:: NAC Baseline through last dose of German cockroach allergen administered during the NAC
Reported as:: Mean · Cumulative proportion of participants

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)
Cumulative proportion of participants	Cockroach Sensitive Adults With Asthma	Cockroach Sensitive Children With Asthma
Dose 1 - 0 mcg/mL	0.00 (0.00 to 0.31)	0.12 (0.03 to 0.31)
Dose 2 - 0.00381 mcg/mL	0.00 (0.00 to 0.31)	0.16 (0.05 to 0.36)
Dose 3 - 0.01204 mcg/mL	0.10 (0.00 to 0.45)	0.16 (0.05 to 0.36)
Dose 4 - 0.0380 mcg/mL	0.22 (0.03 to 0.60)	0.32 (0.15 to 0.54)
Dose 5 - 0.120 mcg/mL	0.44 (0.14 to 0.79)	0.48 (0.28 to 0.69)
Dose 6 - 0.379 mcg/mL	0.56 (0.21 to 0.86)	0.64 (0.43 to 0.82)
Dose 7 - 1.20 mcg/mL	0.56 (0.21 to 0.86)	0.72 (0.51 to 0.88)
Dose 8 - 3.78 mcg/mL	0.56 (0.21 to 0.86)	0.76 (0.55 to 0.91)
Dose 9 - 11.9 mcg/mL	0.67 (0.30 to 0.93)	0.80 (0.59 to 0.93)

SecondaryNumber 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.

Time frame:: NAC Baseline through last dose of German cockroach allergen administered during the NAC
Reported as:: Mean · Count of sneezes

Number of Sneezes at Each of Nine Doses of German Cockroach Allergen
Count of sneezes	Cockroach Sensitive Adults With Asthma	Cockroach Sensitive Children With Asthma
Dose 1 - 0 mcg/mL	0.00 ± 0.00	0.32 ± 0.99
Dose 2 - 0.00381 mcg/mL	0.00 ± 0.00	0.76 ± 1.64
Dose 3 - 0.01204 mcg/mL	0.50 ± 0.97	0.64 ± 1.41
Dose 4 - 0.0380 mcg/mL	1.40 ± 2.55	1.56 ± 2.48
Dose 5 - 0.120 mcg/mL	3.10 ± 3.63	2.80 ± 3.62
Dose 6 - 0.379 mcg/mL	3.80 ± 4.42	4.04 ± 4.61
Dose 7 - 1.20 mcg/mL	4.00 ± 4.27	4.20 ± 4.49
Dose 8 - 3.78 mcg/mL	4.10 ± 4.23	4.48 ± 4.48
Dose 9 - 11.9 mcg/mL	4.40 ± 4.25	4.68 ± 4.36

SecondaryHighest 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.

Time frame:: NAC Baseline through last dose of German cockroach allergen administered during the NAC
Reported as:: Mean · Scores on a Scale

Highest Total Nasal Symptom Score (TNSS)
Scores on a Scale	Cockroach Sensitive Adults With Asthma	Cockroach Sensitive Children With Asthma
Highest Total Nasal Symptom Score (TNSS)	5.20 ± 3.05	5.16 ± 2.12

SecondaryChange 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.

Time frame:: NAC Baseline through last dose of German cockroach allergen administered during the NAC
Reported as:: Mean · Scores on a Scale

Change in Total Nasal Symptom Score (TNSS)
Scores on a Scale	Cockroach Sensitive Adults With Asthma	Cockroach Sensitive Children With Asthma
Change in Total Nasal Symptom Score (TNSS)	4.40 ± 3.17	3.96 ± 2.35

SecondaryChange 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.

Time frame:: NAC Baseline through last dose of German cockroach allergen administered during the NAC
Reported as:: Mean · L/min

Change in Peak Nasal Inspiratory Flow (PNIF) L/Min
L/min	Cockroach Sensitive Adults With Asthma	Cockroach Sensitive Children With Asthma
Change in Peak Nasal Inspiratory Flow (PNIF) L/Min	-33.5 ± 44.5	-18.8 ± 34.0

SecondaryChange 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.

Time frame:: NAC Baseline through last dose of German cockroach allergen administered during the NAC
Reported as:: Mean · L/min

Change in Peak Expiratory Flow (PEF) L/Min
L/min	Cockroach Sensitive Adults With Asthma	Cockroach Sensitive Children With Asthma
Change in Peak Expiratory Flow (PEF) L/Min	25.0 ± 57.0	-5.2 ± 27.4

SecondaryChange 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.

Time frame:: NAC Baseline through last dose of German cockroach allergen administered during the NAC
Reported as:: Mean · Centimeters

Change in Visual Analogue Score
Centimeters	Cockroach Sensitive Adults With Asthma	Cockroach Sensitive Children With Asthma
Change in Visual Analogue Score	1.82 ± 1.66	1.44 ± 1.92

SecondaryChange 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.

Time frame:: NAC Baseline through last dose of German cockroach allergen administered during the NAC
Reported as:: Mean · mcg/L

Change in Log Base 10 Tryptase in Nasal Secretions
mcg/L	Cockroach Sensitive Adults With Asthma	Cockroach Sensitive Children With Asthma
Change in Log Base 10 Tryptase in Nasal Secretions	0.55 ± 0.52	0.25 ± 0.63

SecondaryChange 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.

Time frame:: NAC Baseline through last dose of German cockroach allergen administered during the NAC
Reported as:: Mean · mcg/L

Change in Log Base 10 Albumin in Nasal Secretions
mcg/L	Cockroach Sensitive Adults With Asthma	Cockroach Sensitive Children With Asthma
Change in Log Base 10 Albumin in Nasal Secretions	0.32 ± 0.61	0.19 ± 0.35

Adverse events

Collected over 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. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Phase 1a Cockroach Sensitive Adults With Asthma	0/10 (0%)	1/10 (10%)	4/10 (40%)
Phase 1b Cockroach Sensitive Adults With Asthma	0/4 (0%)	0/4 (0%)	2/4 (50%)
Cockroach Sensitive Children With Asthma	0/25 (0%)	1/25 (4%)	7/25 (28%)

Most frequent serious events

Most frequent serious events
Event	Phase 1a Cockroach Sensitive Adults With Asthma	Phase 1b Cockroach Sensitive Adults With Asthma	Cockroach Sensitive Children With Asthma
Herpes simplexInfections and infestations	1/10	0/4	0/25
AsthmaRespiratory, thoracic and mediastinal disorders	0/10	0/4	1/25

Most frequent other events

Showing 10 of 17

Most frequent other events
Event	Phase 1a Cockroach Sensitive Adults With Asthma	Phase 1b Cockroach Sensitive Adults With Asthma	Cockroach Sensitive Children With Asthma
HypersensitivityImmune system disorders	0/10	1/4	0/25
HeadacheNervous system disorders	2/10	1/4	2/25
Influenza like illnessGeneral disorders	1/10	0/4	0/25
XerosisGeneral disorders	1/10	0/4	0/25
Anaphylactic reactionImmune system disorders	1/10	0/4	0/25
Peak expiratory flow rate decreasedInvestigations	1/10	0/4	0/25
Rhinitis allergicRespiratory, thoracic and mediastinal disorders	1/10	0/4	0/25
Conjunctivitis allergicEye disorders	0/10	0/4	1/25
Vessel puncture site painGeneral disorders	0/10	0/4	1/25
InfluenzaInfections and infestations	0/10	0/4	1/25

Baseline characteristics

Phase 1a and Phase 2 participants who started a Nasal Allergen Challenge

Age, Categorical
Age, Categorical(Participants)	Cockroach Sensitive Adults With Asthma	Cockroach Sensitive Children With Asthma	Total
<=18 years	0	25	25
Between 18 and 65 years	10	0	10
>=65 years	0	0	0

Age, Continuous
Age, Continuous(years)	Cockroach Sensitive Adults With Asthma	Cockroach Sensitive Children With Asthma	Total
Mean	26.0 ± 7.5	11.2 ± 1.9	15.5 ± 8.0

Sex: Female, Male
Sex: Female, Male(Participants)	Cockroach Sensitive Adults With Asthma	Cockroach Sensitive Children With Asthma	Total
Female	7	9	16
Male	3	16	19

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Cockroach Sensitive Adults With Asthma	Cockroach Sensitive Children With Asthma	Total
Hispanic or Latino	0	6	6
Not Hispanic or Latino	10	19	29
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Cockroach Sensitive Adults With Asthma	Cockroach Sensitive Children With Asthma	Total
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	10	18	28
White	0	6	6
More than one race	0	0	0
Unknown or Not Reported	0	1	1

Region of Enrollment
Region of Enrollment(Participants)	Cockroach Sensitive Adults With Asthma	Cockroach Sensitive Children With Asthma	Total
United States	10	25	35

German cockroach allergen Bla g 1, Bla g 2, or Bla g 5 ng/g levels in home dust above LLD (yes/no)
German cockroach allergen Bla g 1, Bla g 2, or Bla g 5 ng/g levels in home dust above LLD (yes/no)(Participants)	Cockroach Sensitive Adults With Asthma	Cockroach Sensitive Children With Asthma	Total
Count of participants	1	9	10

German cockroach allergen skin test wheal size (mm)
German cockroach allergen skin test wheal size (mm)(mm)	Cockroach Sensitive Adults With Asthma	Cockroach Sensitive Children With Asthma	Total
Geometric mean	6.2 ± 1.6	5.6 ± 1.5	5.8 ± 1.5

7 further baseline measures are reported on the registry.

Study locations

4 sites

Children's Hospital Colorado
Aurora, Colorado 80045, United States
Children's National Medical Center
Washington, District of Columbia 20010, United States
Cincinnati Children's Hospital
Cincinnati, Ohio 45229, United States
UT Southwestern Medical Center
Dallas, Texas 75390, United States

References and documents

Publications

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. PubMed 33606312 ↗

Study documents

Study protocol · Sep 9, 2016
Statistical analysis plan · Apr 6, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — 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.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 25, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02710136
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: Inner-City Asthma Consortium
Responsible party: Sponsor
First posted: Mar 16, 2016
Start date: Feb 2016
Primary completion: Apr 11, 2017
Completion: Apr 11, 2017
Results posted: Aug 28, 2018
Last update: Sep 25, 2018

Study contacts

Robert Wood, MD

study chair · Johns Hopkins University

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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