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Completed

NCT Number: NCT00117338

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

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.

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Key information

Conditions

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

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

The duration of treatment is a one time dose.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

montelukast sodium

Drug

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®

Comparator: Placebo (Unspecified)

Drug

Pbo for a study approximately 120 minutes in duration

Primary outcomes

  1. 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

    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 outcomes

  1. Change From Baseline in Modified Pulmonary Index [mPI] Score

    Time frame: Baseline and 60 minutes

    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.

  2. Number of Participants With Treatment Failure (Hospitalization or Time to Decision to Discharge > 2 Hours)

    Time frame: 120 minutes

    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.

  3. 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

    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.

  4. 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

    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.

  5. Change in FEV1 After 15 Minutes Following the End of Study Drug Administration

    Time frame: Baseline and 15 Minutes

    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

  6. 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

    Median total dose of β-agonist administered per patient over a period of 2 hours following the end of study drug administration.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Jul 6, 2005
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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