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Investigate the Effect of the CREON2000A on Asthma Control in Children With Mild to Moderate Persistent Asthma

NCT02715375 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2020-11-03

No results posted yet for this study

Summary

This is a pivotal, 12-month, randomized, sham controlled, parallel group, multicenter, double blind study with an allocation ratio of 1:1. The study population is children between the ages 6 to 17 years, with mild to moderate persistent asthma. The purpose of the study is to determine whether the CREON2000A, an environmental control device, will decrease asthma severity, as measured by the Composite Asthma Severity Index (CASI), in children with mild to moderate persistent allergic asthma over a twelve month period.

Conditions

Interventions

DEVICE

CREON2000A

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • University of Cincinnati

    collaborator OTHER

  • Bernstein Clinical Research Center

    collaborator OTHER

  • General Innovations and Goods, Inc.

    lead INDUSTRY

Principal Investigators

  • Jonathan Bernstein, MD · University of Cincinnati, Cincinnati, Ohio

  • Mark Glazman, PhD · General Innovations and Goods, Inc. (GI&G)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-10
Primary Completion
2020-10-15
Completion
2020-10-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02715375 on ClinicalTrials.gov