|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Children's Hospital Medical Center, Cincinnati |
|---|---|
| Collaborator: |
Merck |
| Information provided by: | Children's Hospital Medical Center, Cincinnati |
| ClinicalTrials.gov Identifier: | NCT00492102 |
Purpose
The purpose of this study is to determine the pharmacokinetics (PK) of montelukast (Singulair) in very low birth weight (VLBW) infants at risk for developing bronchopulmonary dysplasia (the need for supplemental oxygen). The investigators' long-term hypothesis is that inhibition of leukotriene signaling in the VLBW preterm lung will decrease inflammation, remodeling and the incidence of bronchopulmonary dysplasia (BPD).
| Condition | Intervention | Phase |
|---|---|---|
|
Bronchopulmonary Dysplasia |
Drug: Montelukast |
Phase I |
| Study Type: | Interventional |
| Study Design: | Basic Science, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
| Official Title: | Pharmacokinetics of Montelukast in Very Low Birthweight (VLBW) Preterm Infants |
| Estimated Enrollment: | 26 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | March 2010 |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
One dose montelukast, either 0.2 mg or 0.3 mg, based on birth weight, followed by two blood draws for PK values
|
Drug: Montelukast
One dose montelukast, either 0.2 mg or 0.3 mg, based on birth weight, followed by two blood draws for PK values
|
This study proposal will determine the pharmacokinetics (PK) of montelukast (cysteinyl leukotriene receptor-1 or CysLT1 inhibitor) in very low birth weight (VLBW) infants between 500 - 1500g birth weight at risk for developing bronchopulmonary dysplasia (BPD). Montelukast (Singulair) is a FDA approved specific CysLT1 antagonist widely used clinically in the prophylaxis of asthma in children older than 12 months of age and blocks leukotriene signaling in the lung. BPD shares some pathogenic mechanisms with asthma, however Cysteinyl LT receptor blockade has not been studied in preterm infants. Montelukast is metabolized by the cytochrome P450 system which is immature in the preterm infant and hence the need for this study. The investigators' long-term hypothesis is that inhibition of leukotriene signaling in the VLBW preterm lung will decrease inflammation, remodeling and the incidence of BPD. The data will be used to design future efficacy trials of Montelukast in the prevention of bronchopulmonary dysplasia.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Suhas Kallapur, MD | 513-636-3879 | suhas.kallapur@cchmc.org |
| Contact: Anita Thoerner, RN, MSN, CNP | 513-872-2627 | Anita_Thoerner@TriHealth.com |
| United States, Ohio | |
| Good Samaritan Hospital | Recruiting |
| Cincinnati, Ohio, United States, 45220-2489 | |
| Principal Investigator: | Suhas Kallapur, MD | CCHMC/Good Samaritan |
More Information
| Responsible Party: | Cincinnati Children's Medical Center |
| Study ID Numbers: | CCHMC IRB# 05-05-22, TriHealth IRB# 05037-0505 |
| Study First Received: | June 25, 2007 |
| Last Updated: | May 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00492102 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
pharmacokinetics Montelukast bronchopulmonary dysplasia Pharmacokinetics of Montelukast |
|
Birth Weight Respiratory System Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Infant, Premature, Diseases Pharmacologic Actions Leukotriene Antagonists |
Bronchopulmonary Dysplasia Body Weight Montelukast Signs and Symptoms Respiratory Tract Diseases Therapeutic Uses Lung Diseases Infant, Newborn, Diseases |