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| Sponsor: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|---|---|
| Collaborator: |
Pediatric Pharmacology Research Units Network |
| Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00494572 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Status Asthmaticus Asthma |
Drug: Montelukast Other: sterile water |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Pharmacokinetics and Pharmacodynamics of Montelukast in Children, Ages 6 Through 18 Years Old, With Status Asthmaticus Unresponsive to Conventional Treatment |
| Estimated Enrollment: | 52 |
| Study Start Date: | December 2006 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Sterile Water: Sham Comparator
Sterile water
|
Other: sterile water
sterile water
|
|
Montelukast: Active Comparator
10mg rapid dissolving granules in sterile water orally once
|
Drug: Montelukast
10 mg rapid dissolving granule in sterile water orally once
|
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.
Eligibility| Ages Eligible for Study: | 6 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Participant must have received standard therapy for status asthmaticus:
Exclusion Criteria:
Contacts and Locations| United States, Ohio | |
| Rainbow Babies and Children's Hospital | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Eloise Lemon, RN 216-844-3681 eloise.lemon@uhhs.com | |
| Principal Investigator: Jeffrey Blumer, Ph.D., M.D. | |
| Principal Investigator: | Jeffrey Blumer, MD | PPRU |
More Information
| Responsible Party: | University Hospitals Case Medical Center ( Jeffrey L. Blumer, Ph.D., M.D. ) |
| Study ID Numbers: | PPRU 10856 |
| Study First Received: | June 28, 2007 |
| Last Updated: | December 15, 2008 |
| ClinicalTrials.gov Identifier: | NCT00494572 History of Changes |
| Health Authority: | United States: Federal Government |
|
Montelukast Albuterol Status Asthmaticus Asthma |
|
Respiratory System Agents Bronchial Diseases Immune System Diseases Status Asthmaticus Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Asthma Pharmacologic Actions |
Leukotriene Antagonists Montelukast Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Therapeutic Uses Lung Diseases Hypersensitivity, Immediate Respiratory Hypersensitivity |