Montelukast With Status Asthmaticus, Ages 6-18

Asthma Clinical Trial

Official title:

Pharmacokinetics and Pharmacodynamics of Montelukast in Children, Ages 6 Through 18 Years Old, With Status Asthmaticus Unresponsive to Conventional Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00494572
• Other study ID #: PPRU 10856
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: June 28, 2007
• Last updated: December 15, 2008
• Start date: December 2006
• Est. completion date: October 2010

Study information

• Verified date: November 2008
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if montelukast, in addition to standard treatment is helpful in treating patients ages 6-18 who are in the hospital because of status asthmaticus.

Description:

This is a prospective study of montelukast efficacy in addition to standard treatment of status asthmaticus in children who are in the PICU. The study will be stratified in 2 groups: children 6-12 years of age and adolescents 13-18 years of age. Children who meet eligibility requirements will be randomized to receive a rapid-dissolving oral dose of montelukast or placebo. Participants will be given a physical exam, have FEV1 measurements and clinical asthma scores recorded pre- and post- completion of a nebulized albuterol treatment of 0.1 mg/kg/dose (min 2.5 mg/dose). Blood samples for PK analysis will be collected prior to study drug administration and at predetermined time intervals to determine the plasma level of montelukast. In addition, a blood sample will be obtained for genetic study of polymorphisms of CYP3A4, CYP3A5, and CYP2C9.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: October 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

• Participant's parent/legal guardian must give written informed consent and written assent must be obtained form the subject prior to study participation.

1. Obtain consent of the parent/legal guardian using a signed consent form;

2. Obtain assent form minors between the ages of 7-13 using a signed assent form;

3. Obtain assent from minors between the ages of 14-17 by having the subject sign the consent formed signed the parent / legal guardian (Or based on the assessment by the Primary Investigator that the patient is unable to comprehend the study as written in the consent form document, the patient may document assent by signing the assent form).

• Participant, male or female, must be 6 to 18 years of age.

• Participant must have a history of reactive airway disease (RAD) or asthma and must currently be admitted for an acute exacerbation of RAD or asthma.

• Primary physician must believe that patient would benefit from improved bronchodilation and improvement in clinical asthma severity score.

• Participant must have received standard therapy for status asthmaticus:

1. Oxygen as needed

2. >3 nebulized albuterol treatments of at least 2.5mg/dose

3. Methylprednisolone or prednisone loading dose of 2mg/kg

4. Ongoing methylprednisolone therapy @ 0.5mg/kg every 6 hours

• Participant must have received steroids at least 6 hours prior to their inclusion, and must still require nebulized albuterol at least every 2 hours, as determined by PICU team in accordance with the PICU standard for evaluating and treating patients with RAD or asthma exacerbations.

• Participant must have an indwelling catheter in place from which to obtain blood specimens. Catheter may be peripheral or central, arterial or venous.

Exclusion Criteria:

• Known hypersensitivity to montelukast

• Chronic lung disease other than RAD or asthma

• Known renal disease

• Known hepatic disease

• Cardiac or pulmonary congenital anomalies

• Known immunologic disorders other than allergy and atopy

• Other explanations for respiratory distress

• Use of leukotriene modifiers within 2 weeks of the acute presentation

• Pregnant females

• Intubated patients

• Inability to participate in portable spirometry for FEV1 measurement

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Status Asthmaticus

Intervention

Drug:
• Montelukast
10 mg rapid dissolving granule in sterile water orally once

Other:
• sterile water
sterile water

Locations

Country	Name	City	State
United States	Rainbow Babies and Children's Hospital	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Pediatric Pharmacology Research Units Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate effectiveness of Montelukast as adjunctive therapy
Secondary	Estimate the first dose pharmacokinetic parameter of Montelukast