Clinical trial NCT01681732: A Pilot Study of Personalized Medicine for Pediatric Asthma
Official title: A Pilot Study of Personalized Medicine for Pediatric Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
child
pediatric
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2012-09-10
Enrollment: 22
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A pilot study to test the feasibility of a personalized asthma care intervention.

Detailed description: There are two arms in this study. The control arm of the trial will involve the current standard primary care asthma management, and the intervention arm will involve personalized asthma management.

Inclusion criteria include: 1) child age 6-17 years, 2) doctor diagnosed asthma, 3) at least one asthma exacerbation in the previous year. Children with other coexistent pulmonary diseases such as chronic lung disease and cystic fibrosis will be excluded.

The period of participation will be three months for each participant. After screening, each participant will have an initial clinic visit. During this baseline visit, the investigators will collect DNA by taking a saliva sample, the investigators will conduct spirometry, and the investigators will survey the families regarding household level environmental exposures, demographics, and other key variables. The participant will be randomly assigned to a study arm at the end of the baseline visit. The data gathered at the baseline visit will be used to develop a management plan. The investigators will mail a plan to the participant and the primary care provider within a couple weeks of the baseline visit. The investigators will then discuss the plan with the participant via phone. Both groups will receive a plan which MAY be used to guide asthma care. Sample letters follow the protocol. The intervention group will receive basic information on the skin testing, genetic testing, and spirometry. The control group will not receive the genetic information. The control arm will receive the genetic information at the end of the study follow up.

After the baseline visit, the participants will receive a monthly phone call for two months to conduct a survey to assess our study outcomes and covariates. At the 3rd month participants will return to the GCRC for a final clinic visit. During the final visit the investigators will conduct our survey and spirometry and request permission for medical record release.

Eligibility criteria: Inclusion Criteria:

* age 6-17 years
* doctor diagnosed asthma -at least one asthma exacerbation in the previous year. -

Exclusion Criteria:

-Children with other coexistent pulmonary diseases such as chronic lung disease and cystic fibrosis will be excluded.

Primary outcomes:
measure: number of symptom free days over the course of the study
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hersey
country: United States
facility: Penn State Hershey Children's Hospital
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Adam Spanier, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: