Clinical TrialID 1176
Cockroach Nasal Allergen Challenge Pilot
NCT02710136
Asthma|Cockroach Hypersensitivity
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 1176
- Evidence Id
- 1176
- Core Evidence Id
- 1176
- Source Clinical Trial Id
- 1158
- Herb2 Clinical Trial Id
- HBCT001158
- Nct Id
- NCT02710136
- Title
- Cockroach Nasal Allergen Challenge Pilot
- Status
- Completed
- Phase
- Phase 1
- Study Result
- Yes
- Study Condition
- Asthma|Cockroach Hypersensitivity
- Study Type
- Interventional
- Study Design
- Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- BIOLOGICAL: Glycerinated German Cockroach Allergenic Extract
- Intervention Allocation
- Intervention Model
- Single_Group
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Child, Adult
- Enrollment
- 35
- 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), 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
- Sponsor Collaborator
- National Institute of Allergy and Infectious Diseases (NIAID)|Inner-City Asthma Consortium
- Funded By
- NIH
- Location
- 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
- Other Id
- DAIT ICAC-27|CoNAC
- Start Date
- 2016-02
- Primary Completion Date
- 2017-04-11
- Completion Date
- 2017-04-11
- First Posted
- 2016-03-16
- Results First Posted
- 2018-08-28
- Last Update Posted
- 2018-09-25
- Study Document
- Study Protocol, https://cdn.clinicaltrials.gov/large-docs/36/NCT02710136/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/36/NCT02710136/SAP_001.pdf
- Study Url
- https://clinicaltrials.gov/study/NCT02710136
- Title Cn
- Title En
- Cockroach Nasal Allergen Challenge Pilot
- Bilingual Status
- semi_complete