A Study of an Intravenous Drug in Pediatric Patients With Acute Asthma (0476-301)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00117338
First received: June 30, 2005
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

This study will attempt to find out if the addition of an intravenous form of a drug that is already used for treating asthma in children will help resolve asthma attacks faster than using the current standard care alone.


Condition Intervention Phase
Asthma
Drug: montelukast sodium
Drug: Comparator: placebo (unspecified)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind Study Comparing the Clinical Effects of Intravenous Montelukast With Placebo in Pediatric Patients (Ages 6 to 14 Years) With Acute Asthma

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Improvement in FEV1 (Forced Expiratory Volume in 1 Second) Over the First 60 Minutes After Administration [ Time Frame: Baseline and (time weighted average over) 60 Minutes ] [ Designated as safety issue: No ]
    Improvement in FEV1 as the time-weighted average change from baseline over 60 minutes following the end of study drug administration. Time-weighted average of the changes from baseline obtained over the 60 minutes (at 60, 45, 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor.


Secondary Outcome Measures:
  • Change From Baseline in Modified Pulmonary Index [mPI] Score [ Time Frame: Baseline and 60 minutes ] [ Designated as safety issue: No ]

    Change from baseline in modified pulmonary index [mPI] score assessed 60 minutes following the end of study drug administration. mPI questionnaire scores each component on a scale of 0 to 3 (low to high) with a total possible score of 12.

    The components are respiratory rate, wheezing, prolongation of expiration (Inspiratory:Expiratory ratio), and accessory muscle use.


  • Number of Participants With Treatment Failure (Hospitalization or Time to Decision to Discharge > 2 Hours) [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
    Treatment Failure is defined as a.) patients who required hospitalization, or b.) patients for whom a decision to discharge home has not been reached by 2 hours following the end of study drug administration.

  • Time-Weighted Average Change in FEV1 Over 45 Minutes Following the End of Study Drug Administration [ Time Frame: Baseline and (time-weighed average over) 45 Minutes ] [ Designated as safety issue: No ]
    Improvement in FEV1 as time-weighted average change from baseline over 45 minutes following the end of study drug administration: Time-weighted average of the changes from baseline obtained over the 45 minutes (at 45, 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor.

  • Time-Weighted Average Change in FEV1 Over 30 Minutes Following the End of Study Drug Administration [ Time Frame: Baseline and (time-weighted average over) 30 Minutes ] [ Designated as safety issue: No ]
    Improvement in FEV1 as the time-weighted average change from baseline over 30 minutes following the end of study drug administration. Time-weighted average of the changes from baseline obtained over the 30 minutes (at 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor.

  • Change in FEV1 After 15 Minutes Following the End of Study Drug Administration [ Time Frame: Baseline and 15 Minutes ] [ Designated as safety issue: No ]
    Improvement in FEV1 as the time-weighted average change from baseline over the first 15 minutes following the end of study drug administration. Change = 15 minutes value minus Baseline value

  • Total Dose of β-agonist Administered Per Patient Over a Period of 2 Hours Following the End of Study Drug Administration [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
    Median total dose of β-agonist administered per patient over a period of 2 hours following the end of study drug administration.


Enrollment: 276
Study Start Date: August 2005
Study Completion Date: April 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
Drug: Comparator: placebo (unspecified)
Pbo for a study approximately 120 minutes in duration
Active Comparator: 2
montelukast sodium
Drug: montelukast sodium
Montelukast IV 5.25 mg lyophilized (reconstituted in 20 mL of 3.3% dextrose/0.3% sodium chloride) for a study approximately 120 minutes in duration
Other Names:
  • MK0476
  • SINGULAIR®

Detailed Description:

The duration of treatment is a one time dose.

  Eligibility

Ages Eligible for Study:   6 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children 6-14 years of age seeking treatment in emergency departments with acute asthma attacks

Exclusion Criteria:

  • Other respiratory conditions (including congenital lung abnormalities) or other acute illnesses that would complicate current treatment and response for asthma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00117338

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00117338     History of Changes
Other Study ID Numbers: 0476-301, MK0476-301, 2005_026
Study First Received: June 30, 2005
Results First Received: March 16, 2009
Last Updated: October 24, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014