Clinical TrialID 1179

Biomarkers of Cockroach Sublingual Immunotherapy 2

NCT01380327

Asthma|Perennial Allergic Rhinitis

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Record Fields

Scalar fields from the final clinical_trial record.

Clinical Trial Id
1179
Evidence Id
1179
Core Evidence Id
1179
Source Clinical Trial Id
1161
Herb2 Clinical Trial Id
HBCT001161
Nct Id
NCT01380327
Title
Biomarkers of Cockroach Sublingual Immunotherapy 2
Status
Completed
Phase
Phase 1|Phase 2
Study Result
Yes
Study Condition
Asthma|Perennial Allergic Rhinitis
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Intervention
BIOLOGICAL: Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|OTHER: Placebo|BIOLOGICAL: Cockroach Sublingual Immunotherapy (SLIT) - High Dose
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Quadruple
Intervention Purpose
Treatment
Gender
All
Age
Child
Enrollment
99
Outcome Measure
Change in German Cockroach-Specific Serum IgE Over Time, Outcome is the ratio of geometric means for baseline versus post-baseline German cockroach-specific serum IgE. This result is an indicator of immune modulation over time, however its clinical significance is unclear., Baseline through 3 months of treatment
Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)
Funded By
NIH
Location
Children's Memorial Hospital, Chicago, Illinois, 60614, United States|Johns Hopkins University School of Medicine, Baltimore, Maryland, 21287, United States|Henry Ford Health System, Detroit, Michigan, 48202, United States|Cincinnati Children's Hospital, Cincinnati, Ohio, 45229, United States|University of Texas Southwestern Medical Center, Dallas, Texas, 75390, United States
Other Id
DAIT ICAC-17
Start Date
2011-05
Primary Completion Date
2012-06
Completion Date
2012-06
First Posted
2011-06-27
Results First Posted
2014-05-30
Last Update Posted
2014-06-11
Study Document
Study Url
https://clinicaltrials.gov/study/NCT01380327
Title Cn
Title En
Biomarkers of Cockroach Sublingual Immunotherapy 2
Bilingual Status
semi_complete