AsthmaPhase 1NCT02710136
Cockroach Nasal Allergen Challenge Pilot
A Phase 1 study testing Glycerinated German Cockroach Allergenic Extract in people with Asthma and Cockroach Hypersensitivity, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 8 to 55 years
- Conditions the study is for
- Asthma, Cockroach Hypersensitivity
- What is being tested?
- Glycerinated German Cockroach Allergenic Extract
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2016to 11 Apr 2017
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- 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:
- Require a dose of greater than 500mcg of fluticasone per day or the equivalent of another inhaled corticosteroid.
- Have received more than 2 courses of oral or parenteral corticosteroids within the last 12 months or one course within the last 3 months.
Show all 18Show fewer
- Have been treated with depot corticosteroids within the last 12 months.
- Have been hospitalized for asthma within the 12 months prior to recruitment.
- Have had an emergency room visit for asthma within the 3 months prior to recruitment.
- 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.
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
UT Southwestern Medical Center
Dallas, Texas, 75390
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: A Pilot Study to Assess Safety and Feasibility of Cockroach Nasal Allergen Challenge in Cockroach Sensitive Children and Adults With Asthma (ICAC-27)
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
- Asthma, Cockroach Hypersensitivity
- Being tested
- Glycerinated German Cockroach Allergenic Extract
- Keywords
- Asthma, Glycerinated German cockroach allergenic extract, Cockroach Nasal Allergen Challenge
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycerinated German Cockroach Allergenic ExtractBiological
Also called Blattella germanica allergenic extract, Cockroach antigen (CR antigen)
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Glycerinated German Cockroach Allergenic Extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: NAC Baseline through last dose of German cockroach allergen administered during the NAC
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: NAC Baseline through last dose of German cockroach allergen administered during the NAC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completion11 Apr 2017
- Study completion11 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Inner-City Asthma Consortium
- Responsible party
- Sponsor
- Investigators
- Robert Wood, MD, Study chair, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02710136
- Sponsor's protocol ID
- DAIT ICAC-27
- Other IDs
- CoNAC
- Status last verified
- Aug 2018
- First submitted
- 7 Mar 2016
- Last updated
- 25 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- 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.
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 at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess Safety and Feasibility of Cockroach Nasal Allergen Challenge in Cockroach Sensitive Children and Adults With Asthma (ICAC-27)
- ClinicalTrials.gov ID
- NCT02710136
- Acronym / sponsor ID
- DAIT ICAC-27
- Conditions
- Asthma, Cockroach Hypersensitivity
- Keywords
- Asthma, Glycerinated German cockroach allergenic extract, Cockroach Nasal Allergen Challenge
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Inner-City Asthma Consortium
- Study start
- Feb 2016
- Primary completion
- 11 Apr 2017 (actual)
- Study completion
- 11 Apr 2017 (actual)
- First posted
- 16 Mar 2016 (estimated)
- Results
- Posted 28 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glycerinated CR Allergenic Extract | Experimental | Biological: Glycerinated German Cockroach Allergenic ExtractComplete 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. |
Who may qualify
- Ages
- 8 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (18 listed)
- Subjects who meet any of these criteria are not eligible for enrollment as study participants in Phase1a and Phase 2:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glycerinated German Cockroach Allergenic ExtractAlso: Blattella germanica allergenic extract, Cockroach antigen (CR antigen)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). | Biological | Glycerinated CR Allergenic Extract |
Primary outcome
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)
Time frame: NAC Baseline through last dose of German cockroach allergen administered during the 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.
8 secondary outcomes
Number of Sneezes at Each of Nine Doses of German Cockroach Allergen
Time frame: NAC Baseline through last dose of German cockroach allergen administered during the NAC
Highest Total Nasal Symptom Score (TNSS)
Time frame: NAC Baseline through last dose of German cockroach allergen administered during the NAC
Change in Total Nasal Symptom Score (TNSS)
Time frame: NAC Baseline through last dose of German cockroach allergen administered during the NAC
Change in Peak Nasal Inspiratory Flow (PNIF) L/Min
Time frame: NAC Baseline through last dose of German cockroach allergen administered during the NAC
Change in Peak Expiratory Flow (PEF) L/Min
Time frame: NAC Baseline through last dose of German cockroach allergen administered during the NAC
Change in Visual Analogue Score
Time frame: NAC Baseline through last dose of German cockroach allergen administered during the NAC
Change in Log Base 10 Tryptase in Nasal Secretions
Time frame: NAC Baseline through last dose of German cockroach allergen administered during the NAC
Change in Log Base 10 Albumin in Nasal Secretions
Time frame: NAC Baseline through last dose of German cockroach allergen administered during the NAC
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33606312Rudman 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.
- National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
- Division of Allergy, Immunology, and Transplantation (DAIT)Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Wood, MD study chair
Johns Hopkins University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Glycerinated German Cockroach Allergenic Extract in people with Asthma and Cockroach Hypersensitivity, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: NAC Baseline through last dose of German cockroach allergen administered during the NAC). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02710136, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2018.