Acute Care

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Lebrikizumab in Adolescent Patients with Uncontrolled Asthma who are on Inhaled Corticosteroids and a Second Controller Medication (IRB# 43985)

Status: Active

 

Investigators:

  • Principal Investigator: Adam Spanier, MD, PhD, MPH

 

Description:

The burden of asthma is high in the pediatric population. Uncontrolled asthma, in particular, accounts for a major proportion of the overall burden of asthma. Even with guidelines-based asthma therapy (NHLBI 2007), asthma in up to 50% of asthma patients is not well controlled.  The evidence indicates that severe asthma is not a uniform condition and that phenotypic variability is a key aspect of the disease.

Lebrikizumab is being developed for the treatment of patients with uncontrolled asthma despite treatment with a combination of inhaled corticosteroid (ICS) therapy and a second asthma controller medication.   The proposed clinical development program for lebrikizumab will evaluate whether specific modulation of a type 2 helper T cell immune pathway that is mediated by interleukin-13  will improve clinical outcomes in patients with asthma whose disease remains uncontrolled by standard guideline-based therapies.

 

Eligibility:

Inclusion criteria includes:
1) Adolescent between 12-17 years of age at all three screening visits.
2) Asthma diagnosis at least 12 months prior to the first screening visit.
3) A bronchodilator response less than or equal to 12% FEV1 improvement at all screening visits.
4) A pre-bronchodilator FEV1 between 40%-90% predicted at the second and third screening visits.
5) Inhaled corticosteroids or ICS therapy at a daily dose of 500-2000  µg of fluticasone propionate DPI or equivalent 6 months or more prior to the first home visit, no changes should be made within 4 weeks of the first home visit and no changes should be anticipated.
6) Adolescent must be on a second controller medication such as LABAs, LTRAs, LAMAs, or theophylline for 6 months prior to the first visits with no changes 4 weeks prior to the first visits and no anticipated changes.
7) Uncontrolled asthma defined as a ACQ-5 score and at least one of these guidelines (symptoms of asthma more than 2 days in a week, night-time awakening more than 1 time per week, use of SABA rescue medication more than 2 days in a week, or interference with normal daily activity).
8) Adolescent showing 70% adherence to their asthma controller therapy during the screening process.

 

Additional Study Details:

We will recruit participants from the Penn State Milton S. Hershey Medical Center via physician or nurse referral. 

 

Locations:

Penn State Milton S. Hershey Medical Center
Pediatrics at 35 Hope Drive

 

Contacts:

Pediatric Clinical Research Office

717-531-5656

 

Categories:

  • Acute Care