Montelukast With Status Asthmaticus, Ages 6-18

NCT00494572 | Unknown Phase 2 DMC

• 1 other identifier: PPRU 10856
• 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 6-18 who are in the hospital because of status asthmaticus.

Conditions

Status Asthmaticus; Asthma

Keywords

Montelukast; Albuterol; Status Asthmaticus; Asthma

Outcome Measures

Primary Outcomes (1)

• Evaluate effectiveness of Montelukast as adjunctive therapy

Secondary Outcomes (1)

• Estimate the first dose pharmacokinetic parameter of Montelukast

Study Arms (2)

Sterile Water

SHAM COMPARATOR

Sterile water

Other: sterile water

Montelukast

ACTIVE COMPARATOR

10mg rapid dissolving granules in sterile water orally once

Drug: Montelukast

Interventions

Montelukast DRUG

10 mg rapid dissolving granule in sterile water orally once

Montelukast

sterile water OTHER

sterile water

Sterile Water

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 an indwelling catheter in place from which to obtain blood specimens. Catheter may be peripheral or central, arterial or venous.

You may not qualify if:

• 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

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 Blumer, MD

  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 28, 2007
• First Posted: June 29, 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)