A Pilot Study of Personalized Medicine for Pediatric Asthma

Asthma Clinical Trial

Official title:

A Pilot Study of Personalized Medicine for Pediatric Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01681732
• Other study ID #: 38403
• Status: Completed
• Phase: N/A
• First received: September 5, 2012
• Last updated: March 31, 2017
• Start date: September 2012
• Est. completion date: August 29, 2014

Study information

• Verified date: March 2017
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 29, 2014
• Est. primary completion date: August 29, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• Personalized Care Plan
We will develop a personalized plan based on info collected in the primary visit
• Control Standard Care
This is the standard care arm

Locations

Country	Name	City	State
United States	Penn State Hershey Children's Hospital	Hersey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of symptom free days over the course of the study	measured as the number of days during the 2 weeks before the follow-up interview with no asthma symptoms	3 months