Recruiting
Phase 2
Phase 3

Montelukast

Sponsor:

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

Code:

NCT00494572

Conditions

Status Asthmaticus

Asthma

Eligibility Criteria

Sex: All

Age: 6 - 18

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 6-18 who are in the hospital because of status asthmaticus.

Conditions

Status Asthmaticus

Asthma

Study ID

NCT00494572

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: 6 - 18

Healthy Volunteers: Not accepted

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.

1. Obtain consent of the parent/legal guardian using a signed consent form;
2. Obtain assent form minors between the ages of 7-13 using a signed assent form;
3. 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:

1. Oxygen as needed
2. >3 nebulized albuterol treatments of at least 2.5mg/dose
3. Methylprednisolone or prednisone loading dose of 2mg/kg
4. 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 Design

Enrollment

52 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: Sterile Water

Sterile water

active comparator: Montelukast

10mg rapid dissolving granules in sterile water orally once

Interventions

Montelukast

10 mg rapid dissolving granule in sterile water orally once

sterile water

sterile water

Primary outcome measure

  • Evaluate 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

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.