Montelukast With Status Asthmaticus, Ages 2-5
The recruitment status of this study is unknown because the information has not been verified recently.
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:
Collaborator:
Pediatric Pharmacology Research Units Network
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00491790
First received: June 22, 2007
Last updated: December 15, 2008
Last verified: November 2008
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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 2-5 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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Primary Outcome Measures:
- Effectiveness of Montelukast as adjunctive therapy
Secondary Outcome Measures:
- Estimate the first dose pharmacokinetic parameters 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: 1
Sterile Water
|
Other: Sterile water
Sterile water
|
|
Active Comparator: Montelukast
Dissolved granules in sterile water
|
Drug: Montelukast
Montelukast 4 mg rapid dissolving granules in sterile water given orally once
|
Detailed Description:
This is a prospective study of montelukast efficacy in addition to standard treatment of status asthmaticus in children from 2-5 years old who are in the PICU. Children who meet eligibility requirements will be randomized to receive a rapid-dissolving oral dose of montelukast or placebo. Once enrolled, a baseline modified Wood's-Downes clinical asthma severity score will be recorded pre and post completion of a standard nebulized albuterol treatment of 0.15 mg/kg/dose (min2.5mg/dose). Patients who are able will have FEV1 measurements obtained at predetermined intervals for determination of clinical asthma severity score. 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: | 2 Years to 5 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Participant's parent/legal guardian must give written informed consent prior to study participation. When appropriate, written assent from the child will also be obtained.
- Participant, male or female, must be 2 to 5 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
Exclusion Criteria:
- Known hypersensitivity to montelukast
- Chronic lung disease
- Cardiac or pulmonary congenital anomalies
- Known renal disease
- Known hepatic disease
- Known immunologic disorders other than allergy and atopy
- Other explanations for respiratory distress
- Use of leukotriene modifiers within 2 weeks of the acute presentation
- Intubated patients
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00491790
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
Pediatric Pharmacology Research Units Network
Investigators
| Principal Investigator: | Jeffrey L. Blumer, M.D., Ph.D. | PPRU |
More Information
No publications provided
| Responsible Party: | Jeffrey L. Blumer, Ph.D, M.D., University Hospitals Case Medical Center |
| ClinicalTrials.gov Identifier: | NCT00491790 History of Changes |
| Other Study ID Numbers: | PPRU 10854 |
| Study First Received: | June 22, 2007 |
| Last Updated: | December 15, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
montelukast Albuterol Status Asthmaticus Asthma |
Additional relevant MeSH terms:
|
Asthma Status Asthmaticus Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
Montelukast Leukotriene Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013