Clinical TrialID 1177
Cockroach Immunotherapy in Children and Adolescents
NCT03541187
Persistent Asthma
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 1177
- Evidence Id
- 1177
- Core Evidence Id
- 1177
- Source Clinical Trial Id
- 1159
- Herb2 Clinical Trial Id
- HBCT001159
- Nct Id
- NCT03541187
- Title
- Cockroach Immunotherapy in Children and Adolescents
- Status
- Completed
- Phase
- Phase 2
- Study Result
- Yes
- Study Condition
- Persistent Asthma
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
- Intervention
- BIOLOGICAL: German cockroach allergenic extract|BIOLOGICAL: Placebo for German cockroach allergenic extract
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Triple
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Child
- Enrollment
- 82
- Outcome Measure
- Change in Mean Total Nasal Symptom Score (TNSS) From Baseline to 12 Months Between Cockroach SCIT and Placebo, The study's primary endpoint is the mean TNSS change from baseline to 12 months, calculated as the difference between baseline and 12-month mean TNSS up to baseline responsive dose. TNSS (0-12) is the sum of three participant-assessed scores for rhinorrhea, congestion, itching, and staff-monitored sneezing, rated 0=None, 1=Mild, 2=Moderate, 3=Severe. Analysis uses ANCOVA modeling mean TNSS difference with factors for treatment arm, site, and baseline mean TNSS. Least square means (LSmeans), SEs, difference in LSmeans between treatment and placebo groups, 95% CI, and p-value are reported. A greater change in the LSmeans indicates a better outcome., After 12 months
- Sponsor Collaborator
- National Institute of Allergy and Infectious Diseases (NIAID)|Inner-City Asthma Consortium|Rho Federal Systems Division, Inc.
- Funded By
- NIH
- Location
- Children's Hospital Colorado, Aurora, Colorado, 80045, United States|Children's National Medical Center - IMPACT DC, Washington, District of Columbia, 20010, United States|Ann and Robert Lurie Children's Hospital of Chicago, Chicago, Illinois, 60611, United States|Johns Hopkins University, Baltimore, Maryland, 21205, United States|Boston Medical Center, Boston, Massachusetts, 02118, United States|Henry Ford Health System: Division of Allergy and Immunology, Detroit, Michigan, 48202, United States|St. Louis Children's Hospital: Allergy, Immunology and Pulmonary Medicine Program, Saint Louis, Missouri, 63110, United States|Icahn School of Medicine at Mount Sinai, New York, New York, 10029, United States|Columbia University Medical Center, New York, New York, 10032, United States|Cincinnati Children's Hospital, Cincinnati, Ohio, 45229-3039, United States|University of Texas Southwestern Medical School, Dallas, Texas, 75390-8859, United States
- Other Id
- DAIT ICAC-28|UM1AI114271|NIAID CRMS ID#: 38517
- Start Date
- 2018-07-16
- Primary Completion Date
- 2022-06-02
- Completion Date
- 2022-06-03
- First Posted
- 2018-05-30
- Results First Posted
- 2023-05-22
- Last Update Posted
- 2023-05-22
- Study Document
- Study Protocol, https://cdn.clinicaltrials.gov/large-docs/87/NCT03541187/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/87/NCT03541187/SAP_001.pdf
- Study Url
- https://clinicaltrials.gov/study/NCT03541187
- Title Cn
- Title En
- Cockroach Immunotherapy in Children and Adolescents
- Bilingual Status
- semi_complete