Montelukast With Status Asthmaticus, Ages 2-5

NCT00491790 | Unknown Phase 2 DMC

• 1 other identifier: PPRU 10854
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Keywords

montelukast; Albuterol; Status Asthmaticus; Asthma

Outcome Measures

Primary Outcomes (1)

• Effectiveness of Montelukast as adjunctive therapy

Secondary Outcomes (1)

• Estimate the first dose pharmacokinetic parameters of Montelukast

Study Arms (2)

1

SHAM COMPARATOR

Sterile Water

Other: Sterile water

Montelukast

ACTIVE COMPARATOR

Dissolved granules in sterile water

Drug: Montelukast

Interventions

Montelukast DRUG

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

Montelukast

Sterile water OTHER

Sterile water

1

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead
• Pediatric Pharmacology Research Units Network: collaborator

Study Sites (1)

Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

RECRUITING

MeSH Terms

Conditions

Status Asthmaticus; Asthma

Interventions

montelukast

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Jeffrey L. Blumer, M.D., Ph.D.

  PPRU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 22, 2007
• First Posted: June 26, 2007
• Study Start: December 1, 2006
• Primary Completion: January 1, 2010
• Study Completion: October 1, 2010
• Last Updated: December 16, 2008

Record last verified: 2008-11

Locations

US (1)