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

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ClinicalTrials.gov Identifier: NCT00117338
Recruitment Status : Completed
First Posted : July 6, 2005
Results First Posted : August 11, 2009
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE June 30, 2005
First Posted Date  ICMJE July 6, 2005
Results First Submitted Date  ICMJE March 16, 2009
Results First Posted Date  ICMJE August 11, 2009
Last Update Posted Date April 6, 2017
Study Start Date  ICMJE July 2005
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2010)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00117338 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2010)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of an Intravenous Drug in Pediatric Patients With Acute Asthma (0476-301)
Official Title  ICMJE 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
Brief 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.
Detailed Description The duration of treatment is a one time dose.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • 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®
  • Drug: Comparator: placebo (unspecified)
    Pbo for a study approximately 120 minutes in duration
Study Arms  ICMJE
  • Placebo Comparator: 1
    Placebo
    Intervention: Drug: Comparator: placebo (unspecified)
  • Active Comparator: 2
    montelukast sodium
    Intervention: Drug: montelukast sodium
Publications * Morris CR, Becker AB, Piñieiro A, Massaad R, Green SA, Smugar SS, Gurner DM. A randomized, placebo-controlled study of intravenous montelukast in children with acute asthma. Ann Allergy Asthma Immunol. 2010 Feb;104(2):161-71.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 26, 2009)
276
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Brazil,   Chile,   Colombia,   Costa Rica,   Guatemala,   India,   Lithuania,   Mexico,   Peru,   United States
 
Administrative Information
NCT Number  ICMJE NCT00117338
Other Study ID Numbers  ICMJE 0476-301
MK0476-301
2005_026
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP