- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00494572
Montelukast With Status Asthmaticus, Ages 6-18
December 15, 2008 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Pharmacokinetics and Pharmacodynamics of Montelukast in Children, Ages 6 Through 18 Years Old, With Status Asthmaticus Unresponsive to Conventional Treatment
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
52
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44106
- Recruiting
- Rainbow Babies and Children's Hospital
-
Contact:
- Eloise Lemon, RN
- Phone Number: 216-844-3681
- Email: eloise.lemon@uhhs.com
-
Principal Investigator:
- Jeffrey Blumer, Ph.D., M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Sterile Water
Sterile water
|
sterile water
|
Active Comparator: Montelukast
10mg rapid dissolving granules in sterile water orally once
|
10 mg rapid dissolving granule in sterile water orally once
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Evaluate effectiveness of Montelukast as adjunctive therapy
|
Secondary Outcome Measures
Outcome Measure |
---|
Estimate the first dose pharmacokinetic parameter of Montelukast
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jeffrey Blumer, MD, PPRU
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Primary Completion (Anticipated)
January 1, 2010
Study Completion (Anticipated)
October 1, 2010
Study Registration Dates
First Submitted
June 28, 2007
First Submitted That Met QC Criteria
June 28, 2007
First Posted (Estimate)
June 29, 2007
Study Record Updates
Last Update Posted (Estimate)
December 16, 2008
Last Update Submitted That Met QC Criteria
December 15, 2008
Last Verified
November 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Status Asthmaticus
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Asthmatic Agents
- Respiratory System Agents
- Leukotriene Antagonists
- Hormone Antagonists
- Cytochrome P-450 CYP1A2 Inducers
- Cytochrome P-450 Enzyme Inducers
- Montelukast
Other Study ID Numbers
- PPRU 10856
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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