Recruiting
Phase 2
Phase 3

Montelukast with Status Asthmaticus

Sponsor:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Code:

NCT00491790

Conditions

Status Asthmaticus

Asthma

Eligibility Criteria

Sex: All

Age: 2 - 5

Healthy Volunteers: Not accepted

Interventions

Montelukast

Sterile water

Study Details

Brief summary:

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.

Conditions

Status Asthmaticus

Asthma

Study ID

NCT00491790

Start date

Dec, 2006

Status verified date

Nov, 2008

Completion date

Oct, 2010

Anticipated

Primary completion date

Jan, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 5

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

52 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: 1

Sterile Water

active comparator: Montelukast

Dissolved granules in sterile water

Interventions

Montelukast

Montelukast 4 mg rapid dissolving granules in sterile water given orally once

Sterile water

Sterile water

Primary outcome measure

  • Effectiveness of Montelukast as adjunctive therapy [ Time Frame: undefined ]

Central Contacts and Locations

Locations

Rainbow Babies and Children's Hospital

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Eloise Lemon, RN

216-844-3681eloise.lemon@uhhs.com

Principal Investigator:

Jeffrey Blumer, Ph.D., M.D.

More Information

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Last update posted

Dec 16, 2008

Last verified

Nov, 2008

Keywords

  • montelukast
  • Albuterol
  • Status Asthmaticus
  • Asthma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) on 2008-12-16.