Montelukast With Status Asthmaticus, Ages 6-18
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2008 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00494572
First Posted: June 29, 2007
Last Update Posted: December 16, 2008
Collaborator:
Pediatric Pharmacology Research Units Network
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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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 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment |
| Official Title: | Pharmacokinetics and Pharmacodynamics of Montelukast in Children, Ages 6 Through 18 Years Old, With Status Asthmaticus Unresponsive to Conventional Treatment |
Resource links provided by NLM:
MedlinePlus related topics:
Infertility
Drug Information available for:
Montelukast
U.S. FDA Resources
Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Primary Outcome Measures:
- Evaluate effectiveness of Montelukast as adjunctive therapy
Secondary Outcome Measures:
- Estimate the first dose pharmacokinetic parameter of Montelukast
| 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 |
|---|---|
|
Sham Comparator: Sterile Water
Sterile water
|
Other: sterile water
sterile water
|
|
Active Comparator: Montelukast
10mg rapid dissolving granules in sterile water orally once
|
Drug: Montelukast
10 mg rapid dissolving granule in sterile water orally once
|
Detailed 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.
Eligibility
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| Ages Eligible for Study: | 6 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
- Obtain consent of the parent/legal guardian using a signed consent form;
- Obtain assent form minors between the ages of 7-13 using a signed assent form;
- 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:
- Oxygen as needed
- >3 nebulized albuterol treatments of at least 2.5mg/dose
- Methylprednisolone or prednisone loading dose of 2mg/kg
- 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
Contacts and Locations
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00494572
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. | |
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Pediatric Pharmacology Research Units Network
Investigators
| Principal Investigator: | Jeffrey Blumer, MD | PPRU |
More Information
| Responsible Party: | Jeffrey L. Blumer, Ph.D., M.D., University Hospitals Case Medical Center |
| ClinicalTrials.gov Identifier: | NCT00494572 History of Changes |
| Other Study ID Numbers: |
PPRU 10856 |
| First Submitted: | June 28, 2007 |
| First Posted: | June 29, 2007 |
| Last Update Posted: | December 16, 2008 |
| Last Verified: | November 2008 |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
Montelukast Albuterol Status Asthmaticus Asthma |
Additional relevant MeSH terms:
|
Status Asthmaticus Asthma Bronchial Diseases Respiratory Tract Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Montelukast |
Anti-Asthmatic Agents Respiratory System Agents Leukotriene Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Cytochrome P-450 CYP1A2 Inducers Cytochrome P-450 Enzyme Inducers Molecular Mechanisms of Pharmacological Action |