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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00117338
• Other study ID #: 0476-301
• Secondary ID: MK0476-3012005_0
• Status: Completed
• Phase: Phase 3
• Start date: July 2005
• Est. completion date: March 2008

Study information

• Verified date: January 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The duration of treatment is a one time dose.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

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
• Comparator: placebo (unspecified)
Pbo for a study approximately 120 minutes in duration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in FEV1 (Forced Expiratory Volume in 1 Second) Over the First 60 Minutes After Administration	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.	Baseline and (time weighted average over) 60 Minutes
Secondary	Change From Baseline in Modified Pulmonary Index [mPI] Score	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.	Baseline and 60 minutes
Secondary	Number of Participants With Treatment Failure (Hospitalization or Time to Decision to Discharge > 2 Hours)	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.	120 minutes
Secondary	Time-Weighted Average Change in FEV1 Over 45 Minutes Following the End of Study Drug Administration	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.	Baseline and (time-weighed average over) 45 Minutes
Secondary	Time-Weighted Average Change in FEV1 Over 30 Minutes Following the End of Study Drug Administration	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.	Baseline and (time-weighted average over) 30 Minutes
Secondary	Change in FEV1 After 15 Minutes Following the End of Study Drug Administration	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	Baseline and 15 Minutes
Secondary	Total Dose of ß-agonist Administered Per Patient Over a Period of 2 Hours Following the End of Study Drug Administration	Median total dose of ß-agonist administered per patient over a period of 2 hours following the end of study drug administration.	120 minutes